Hepatoblastoma Clinical Trial
Official title:
Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)
Verified date | April 2024 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This partially randomized phase II/III trial studies how well, in combination with surgery, cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or hepatocellular carcinoma. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells than one type of chemotherapy alone.
Status | Active, not recruiting |
Enrollment | 537 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 30 Years |
Eligibility | Inclusion Criteria: - Patients in Group F must have a body surface area (BSA) >= 0.6 m^2 - Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score - Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted below; patients with a diagnosis of hepatocellular neoplasm, not otherwise specified, should be classified and treated per hepatoblastoma treatment arms; note that rapid central pathology review is required in some cases; please note: all patients with histology as assessed by the institutional pathologist consistent with pure small cell undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by immunohistochemistry (IHC) according to the practices at the institution - Patients with histology consistent with pure SCU must have positive INI1/SMARCB1 staining - For all Group A patients, WDF status as determined by rapid review will be used to further stratify patients to Group A1 or A2 - For Groups B, C and D, rapid review is required if patients are either >= 8 years of age or have an alphafetoprotein (AFP) =< 100 at diagnosis - For all Groups E and F patients, rapid central pathology review is required - In emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy - Clinical situations in which emergent treatment may be indicated include, but are not limited to, the following circumstances: - Anatomic or mechanical compromise of critical organ function by tumor (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.) - Uncorrectable coagulopathy - For a patient to maintain eligibility for AHEP1531 when emergent treatment is given, the following must occur: - The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alphafetoprotein (AFP), and must meet all AHEP1531 eligibility criteria at the time of emergent treatment - Patient must be enrolled on AHEP1531 prior to initiating protocol therapy; a patient will be ineligible if any chemotherapy is administered prior to AHEP1531 enrollment - Note: If the patient receives AHEP1531 chemotherapy emergently PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aims - Patients may have had surgical resection of the hepatic malignancy prior to enrollment; all other anti-cancer therapy for the current liver lesion is prohibited - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 or - A serum creatinine based on age/gender as follows: - Age: maximum serum creatinine (mg/dL) - 1 month to < 6 months: 0.4 (male and female) - 6 months to < 1 year: 0.5 (male and female) - 1 to < 2 years: 06 (male and female) - 2 to < 6 years: 0.8 (male and female) - 6 to < 10 years: 1 (male and female) - 10 to < 13 years: 1.2 (male and female) - 13 to < 16 years: 1.5 (male), 1.4 (female) - >= 16 years: 1.7 (male), 1.4 (female) - Total bilirubin =< 5 x upper limit of normal (ULN) for age - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 10 x upper limit of normal (ULN) for age - Shortening fraction of >= 28% by echocardiogram (for patients on doxorubicin-containing regimens [Groups C, D, E2, and F] assessed within 8 weeks prior to study enrollment) or - Ejection fraction of >= 47% by echocardiogram or radionuclide angiogram (for patients on doxorubicin-containing regimens [Groups C, D, E2, and F] assessed within 8 weeks prior to study enrollment) - Group F patients only: QT/corrected QT (QTc) interval =< 450 milliseconds for males and =< 470 milliseconds for females (assessed within 8 weeks prior to study enrollment) - Normal pulmonary function tests (including diffusion capacity of the lung for carbon monoxide [DLCO]) if there is clinical indication for determination (e.g. dyspnea at rest, known requirement for supplemental oxygen) (for patients receiving chemotherapy [Groups A, B, C, D, E2, F]); for patients who do not have respiratory symptoms or requirement for supplemental oxygen, pulmonary function tests (PFTs) are NOT required - All patients and/or their parents or legal guardians must sign a written informed consent - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: - Prior chemotherapy or tumor directed therapy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser); therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible - Patients who are currently receiving another investigational drug - Patients who are currently receiving other anticancer agents - Patients with uncontrolled infection - Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma - Patients with hypersensitivity to any drugs on their expected treatment arm - Group C: Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD) - Group D: - Patients with chronic inflammatory bowel disease and/or bowel obstruction - Patients with concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment - Group F: - Patients with peripheral sensitive neuropathy with functional impairment - Patients with a personal or family history of congenital long QT syndrome - These criteria apply ONLY to patients who may receive chemotherapy (all groups other than Group E1): - Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential - Lactating females who plan to breastfeed their infants - Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation - Note for Group F: patients of childbearing potential should use effective birth control during treatment with sorafenib and for at least 2 weeks after stopping treatment |
Country | Name | City | State |
---|---|---|---|
Australia | John Hunter Children's Hospital | Hunter Regional Mail Centre | New South Wales |
Australia | Women's and Children's Hospital-Adelaide | North Adelaide | South Australia |
Australia | Royal Children's Hospital | Parkville | Victoria |
Australia | Perth Children's Hospital | Perth | Western Australia |
Australia | Sydney Children's Hospital | Randwick | New South Wales |
Australia | Queensland Children's Hospital | South Brisbane | Queensland |
Australia | The Children's Hospital at Westmead | Westmead | New South Wales |
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Canada | Children's Hospital | London | Ontario |
Canada | Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec |
Canada | The Montreal Children's Hospital of the MUHC | Montreal | Quebec |
Canada | CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) | Quebec | |
Canada | Jim Pattison Children's Hospital | Saskatoon | Saskatchewan |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Hospital for Sick Children | Toronto | Ontario |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
New Zealand | Christchurch Hospital | Christchurch | |
New Zealand | Starship Children's Hospital | Grafton | Auckland |
Puerto Rico | San Jorge Children's Hospital | San Juan | |
Puerto Rico | University Pediatric Hospital | San Juan | |
Saudi Arabia | King Faisal Specialist Hospital and Research Centre | Riyadh | |
United States | Children's Hospital Medical Center of Akron | Akron | Ohio |
United States | Albany Medical Center | Albany | New York |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania |
United States | Providence Alaska Medical Center | Anchorage | Alaska |
United States | C S Mott Children's Hospital | Ann Arbor | Michigan |
United States | Mission Hospital | Asheville | North Carolina |
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Augusta University Medical Center | Augusta | Georgia |
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Dell Children's Medical Center of Central Texas | Austin | Texas |
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Children's Hospital of Alabama | Birmingham | Alabama |
United States | Saint Luke's Cancer Institute - Boise | Boise | Idaho |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Tufts Children's Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Vermont and State Agricultural College | Burlington | Vermont |
United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | West Virginia University Charleston Division | Charleston | West Virginia |
United States | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
United States | University of Virginia Cancer Center | Charlottesville | Virginia |
United States | T C Thompson Children's Hospital | Chattanooga | Tennessee |
United States | Lurie Children's Hospital-Chicago | Chicago | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | University of Illinois | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Rainbow Babies and Childrens Hospital | Cleveland | Ohio |
United States | Columbia Regional | Columbia | Missouri |
United States | Prisma Health Richland Hospital | Columbia | South Carolina |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Driscoll Children's Hospital | Corpus Christi | Texas |
United States | Medical City Dallas Hospital | Dallas | Texas |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Dayton Children's Hospital | Dayton | Ohio |
United States | Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado |
United States | Blank Children's Hospital | Des Moines | Iowa |
United States | Ascension Saint John Hospital | Detroit | Michigan |
United States | Children's Hospital of Michigan | Detroit | Michigan |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Kaiser Permanente Downey Medical Center | Downey | California |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Michigan State University Clinical Center | East Lansing | Michigan |
United States | El Paso Children's Hospital | El Paso | Texas |
United States | Inova Fairfax Hospital | Falls Church | Virginia |
United States | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida |
United States | Cook Children's Medical Center | Fort Worth | Texas |
United States | University of Florida Health Science Center - Gainesville | Gainesville | Florida |
United States | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | BI-LO Charities Children's Cancer Center | Greenville | South Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
United States | Penn State Children's Hospital | Hershey | Pennsylvania |
United States | Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Children's Mercy Hospitals and Clinics | Kansas City | Missouri |
United States | East Tennessee Childrens Hospital | Knoxville | Tennessee |
United States | Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada |
United States | Summerlin Hospital Medical Center | Las Vegas | Nevada |
United States | Sunrise Hospital and Medical Center | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Miller Children's and Women's Hospital Long Beach | Long Beach | California |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Mattel Children's Hospital UCLA | Los Angeles | California |
United States | Norton Children's Hospital | Louisville | Kentucky |
United States | Covenant Children's Hospital | Lubbock | Texas |
United States | UMC Cancer Center / UMC Health System | Lubbock | Texas |
United States | Valley Children's Hospital | Madera | California |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
United States | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Saint Jude Children's Research Hospital | Memphis | Tennessee |
United States | Banner Children's at Desert | Mesa | Arizona |
United States | Nicklaus Children's Hospital | Miami | Florida |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
United States | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota |
United States | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota |
United States | West Virginia University Healthcare | Morgantown | West Virginia |
United States | Morristown Medical Center | Morristown | New Jersey |
United States | The Children's Hospital at TriStar Centennial | Nashville | Tennessee |
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
United States | Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
United States | Yale University | New Haven | Connecticut |
United States | The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York |
United States | Children's Hospital New Orleans | New Orleans | Louisiana |
United States | Ochsner Medical Center Jefferson | New Orleans | Louisiana |
United States | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Mount Sinai Hospital | New York | New York |
United States | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | NYP/Weill Cornell Medical Center | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Children's Hospital of The King's Daughters | Norfolk | Virginia |
United States | Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois |
United States | Kaiser Permanente-Oakland | Oakland | California |
United States | UCSF Benioff Children's Hospital Oakland | Oakland | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Children's Hospital of Orange County | Orange | California |
United States | AdventHealth Orlando | Orlando | Florida |
United States | Arnold Palmer Hospital for Children | Orlando | Florida |
United States | Nemours Children's Hospital | Orlando | Florida |
United States | Lucile Packard Children's Hospital Stanford University | Palo Alto | California |
United States | Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois |
United States | Saint Joseph's Regional Medical Center | Paterson | New Jersey |
United States | Sacred Heart Hospital | Pensacola | Florida |
United States | Saint Jude Midwest Affiliate | Peoria | Illinois |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | Phoenix Childrens Hospital | Phoenix | Arizona |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Legacy Emanuel Children's Hospital | Portland | Oregon |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Naval Medical Center - Portsmouth | Portsmouth | Virginia |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Renown Regional Medical Center | Reno | Nevada |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Beaumont Children's Hospital-Royal Oak | Royal Oak | Michigan |
United States | Sutter Medical Center Sacramento | Sacramento | California |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Cardinal Glennon Children's Medical Center | Saint Louis | Missouri |
United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
United States | Primary Children's Hospital | Salt Lake City | Utah |
United States | Children's Hospital of San Antonio | San Antonio | Texas |
United States | Methodist Children's Hospital of South Texas | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Naval Medical Center -San Diego | San Diego | California |
United States | Rady Children's Hospital - San Diego | San Diego | California |
United States | UCSF Medical Center-Mission Bay | San Francisco | California |
United States | Memorial Health University Medical Center | Savannah | Georgia |
United States | Maine Children's Cancer Program | Scarborough | Maine |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | State University of New York Upstate Medical University | Syracuse | New York |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | Mary Bridge Children's Hospital and Health Center | Tacoma | Washington |
United States | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida |
United States | Tampa General Hospital | Tampa | Florida |
United States | Scott and White Memorial Hospital | Temple | Texas |
United States | ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio |
United States | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California |
United States | New York Medical College | Valhalla | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
United States | Saint Mary's Hospital | West Palm Beach | Florida |
United States | Alfred I duPont Hospital for Children | Wilmington | Delaware |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Canada, New Zealand, Puerto Rico, Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Failure free survival | Failure free survival is defined as the time from randomization (or registration into the trial for non-randomized patients) to first failure event. Failure events are: progression of existing disease or occurrence of disease at new sites, death from any cause prior to disease progression, diagnosis of a second malignant neoplasm, or failure to go to resection. | 3 years | |
Other | Overall survival | Overall survival is defined as the time from randomization (or registration for non-randomized patients) to death from any cause. | 3 years | |
Other | Percentage of patients experiencing grade 3 or higher adverse events | The percentage of patients experiencing grade 3 or higher toxicity will be reported, where adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. | 8 months | |
Other | Percentage of patients with chemotherapy-related cardiac, nephro- and oto-toxicity | Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. | Up to 5 years | |
Other | Percentage of patients with hearing loss | Hearing loss will be measured according to the SIOP Boston Scale for ototoxicity. | Up to 5 years | |
Other | Best response | Response in hepatocellular carcinoma (HCC) will be defined as complete (CR) or partial (PR) response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Response in HB will be defined as CR or PR based on radiological response (RECIST v1.1) and AFP decline. | Up to 5 years | |
Other | Percentage of participants who are surgically resectable | Surgical resectability is defined as complete resection, partial resection or transplant following randomization (or enrollment for non-randomized patients). | Up to 5 years | |
Other | Percentage of participants with adherence to surgical guidelines | Adherence to surgical guidelines is defined as the local clinician's surgical decision to resect or not compared to the current SIOPEL surgical guidelines. | Up to 5 years | |
Primary | Event-free survival (EFS) | EFS is defined as the time from randomization (or registration into the trial for non-randomized patients) to the first failure event where the failure events are defined as: progression of existing disease or occurrence of disease at new sites, death from any cause prior to disease progression, or diagnosis of a second malignant neoplasm. Patients who have not had an event will be censored at their last follow-up date. EFS for group A, group B1, group C, group D1, group D2 and E will be presented. | 3 years | |
Primary | Percentage of Group B2 participants with resectable tumors | Group B patients who are unresectable after cycles 1 & 2 of cisplatin treatment will be assigned to Group B2. These patients will receive cycles 3-6 of cisplatin treatment. | 6 months | |
Primary | Response rate for Group F patients | Response is defined as complete (CR) or partial (PR) response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Patients who are not assessable for response - e.g. because of early stopping of treatment or death - will be classified as non-responders. | Up to 5 years |
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