Gastric Cancer Clinical Trial
Official title:
Non-Operative Therapy Of Local-Regional Carcinoma Of The Esophagus: A Randomizd Phase II Study Of Two Paclitaxel-Based Chemoradiotherapy Regimens
Verified date | July 2004 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy
plus radiation therapy with and without fluorouracil in treating patients who have cancer of
the esophagus or stomach.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction - Stage I-III (T1, N1, M0; T2-4, N any, M0) - Supraclavicular or celiac lymph node involvement allowed - Disease entirely confined to the esophagus or gastroesophageal junction and peri-esophageal soft tissue - Cervical esophageal carcinoma allowed - No tumor extension beyond 2 cm into stomach - No multiple primary carcinomas of the esophagus - No evidence of disseminated cancer - No tracheoesophageal fistula or direct invasion into the mucosa of the trachea or major bronchi - Bronchoscopy with biopsy and cytology required if the primary carcinoma is less than 26 cm from the incisors or is at or above the carina by imaging study PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 150,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Not specified Renal: - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 65 mL/min Cardiovascular: - No uncontrolled heart disease - No uncontrolled hypertension Other: - Total oral/enteral intake must be at least 1,700 kCal/day - Not pregnant or nursing - Fertile patients must use effective contraception - No uncontrolled diabetes - No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior systemic chemotherapy - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior chest radiotherapy Surgery: - No prior major esophageal surgery |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Akron City Hospital at Summa Health System | Akron | Ohio |
United States | Akron General's McDowell Cancer Center | Akron | Ohio |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland |
United States | St. Luke's Hospital Cancer Center | Bethlehem | Pennsylvania |
United States | SUNY Downstate Medical Center | Brooklyn | New York |
United States | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Mount Carmel West Hospital | Columbus | Ohio |
United States | CCOP - Dayton | Dayton | Ohio |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill | Pennsylvania |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Wendt Regional Cancer Center at Finley Hospital | Dubuque | Iowa |
United States | Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg | Pennsylvania |
United States | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | East Syracuse | New York |
United States | Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center | Edgewood | Kentucky |
United States | University of Florida Shands Cancer Center | Gainesville | Florida |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Monmouth Medical Center | Long Branch | New Jersey |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin |
United States | Community Memorial Hospital | Menomonee Falls | Wisconsin |
United States | Baptist-South Miami Regional Cancer Program | Miami | Florida |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin |
United States | Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin |
United States | Mobile Infirmary Medical Center | Mobile | Alabama |
United States | Cancer Center at Ball Memorial Hospital | Muncie | Indiana |
United States | Cottonwood Hospital Medical Center | Murray | Utah |
United States | Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans | Louisiana |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Leavey Cancer Center at Northridge Hospital Medical Center | Northridge | California |
United States | McKay-Dee Hospital Center | Ogden | Utah |
United States | Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha | Nebraska |
United States | Cancer Center at Paoli Memorial Hospital | Paoli | Pennsylvania |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | Foundation for Cancer Research and Education | Phoenix | Arizona |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
United States | Atlantic City Medical Center - Mainland Division | Pomona | New Jersey |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Utah Valley Regional Medical Center - Provo | Provo | Utah |
United States | All Saints Cancer Center at All Saints Healthcare | Racine | Wisconsin |
United States | Reading Hospital and Medical Center | Reading | Pennsylvania |
United States | Dixie Regional Medical Center | Saint George | Utah |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | LDS Hospital | Salt Lake City | Utah |
United States | University of Utah Health Sciences Center | Salt Lake City | Utah |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Union Hospital | Terre Haute | Indiana |
United States | CCOP - Toledo Community Hospital | Toledo | Ohio |
United States | Community Medical Center | Toms River | New Jersey |
United States | Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin |
United States | CCOP - MainLine Health | Wynnewood | Pennsylvania |
United States | Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI) |
United States,
Ajani JA, Winter K, Komaki R, Kelsen DP, Minsky BD, Liao Z, Bradley J, Fromm M, Hornback D, Willett CG. Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the — View Citation
Komaki R, Winter K, Ajani A, et al.: A randomized phase II study of two paclitaxel-based chemoradiotherapy regimens for patients with the non-operative esophageal carcinoma (RTOG 0113). [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-142, S79-80
Komaki R, Winter K, Ajani J: Non-operative therapy of local-regional carcinoma of the esophagus: a randomized phase II study of two paclitaxel-based chemoradiotherapy regimens (RTOG 0113). [Abstract] The American Radium Society 89th Annual Meeting, May 5-
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