Recurrent Rectal Cancer Clinical Trial
Official title:
Phase I Study of Neoadjuvant Short Course Radiotherapy Concurrent With Infusional 5-Fluorouracil for the Treatment of Locally Advanced Rectal Cancer
Verified date | July 2021 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I trial studies the side effects and best dose of fluorouracil when given together with radiation therapy followed by combination chemotherapy before and after surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, 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 more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving additional combination chemotherapy after surgery may kill any remaining tumor cells. Giving radiation therapy and fluorouracil followed by combination chemotherapy before and after surgery may be a better treatment for rectal cancer.
Status | Completed |
Enrollment | 14 |
Est. completion date | May 13, 2021 |
Est. primary completion date | May 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pathologically proven diagnosis of adenocarcinoma of the rectum (located below the peritoneal reflection or begins within 15 cm of the anal verge on flexible endoscopy) within 90 days of registration; diagnosis of rectal adenocarcinoma must be obtained by biopsy technique that does not completely excise the lesion (eg, fine needle aspiration, core needle biopsy) - Clinically determined to be clinically staged (American Joint Committee on Cancer (AJCC) 7th edition [ed.]) T3-4 N0 M0 or T any N1-2 M0 based upon the following minimum diagnostic workup within 90 days prior to registration: - Colonoscopy - History/physical examination (including medication history screen for contraindications) - Contrast-enhanced imaging of the abdomen and pelvis either by computed tomography (CT), magnetic resonance imaging (MRI), or whole body positron emission tomography (PET)-CT (preferred) - Chest x-ray (or CT) of the chest to exclude distant metastases (except for those who have had whole body PET-CT per above bullet point) - Transrectal ultrasound (TRUS) or MRI for T staging - Eastern Cooperative Oncology Group (ECOG) performance status =< 1 - Absolute neutrophil count (ANC) >= 1,800 cells/mm^3 - Platelets >= 100,000 cells/mm^3 - Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable) - Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN) - Alkaline phosphatase < 2.5 x ULN - Bilirubin =< 1.5 ULN - Calculated creatinine clearance (CrCl) > 50 mL/min using Cockcroft-Gault formula - Must be deemed a candidate for curative resection by the surgical oncologist who will be performing the operation - Must provide study-specific informed consent prior to study entry - Must have a negative serum pregnancy test Exclusion Criteria: - Prior radiotherapy to the region of the body that would result in overlap of RT fields with the current protocol treatment - Severe, active comorbidity, defined as follows: - Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months - Transmural myocardial infarction within the last 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol - Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of treatment protocol or follow up - Known, existing uncontrolled coagulopathy; subjects on therapeutic anticoagulation may be enrolled provided that they have been clinically stable on anti-coagulation for at least 2 weeks - Major surgery within 28 days of study enrollment (other than diverting colostomy) - Crohn's disease or ulcerative colitis requiring hospitalization, surgery or immunosuppressive medications - Prior allergic reaction to 5-Fluorouracil or oxaliplatin - Any evidence of distant metastases (M1) - Extension of malignant disease into the anal canal - Pregnant as determined by a positive serum pregnancy test within 14 days prior to registration on study (for females of childbearing potential) |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose limiting toxicity for continuous infusional 5-Fluorouracil given concurrently with short course pelvic radiation | To determine the maximum tolerated dose of continuous infusional 5-Fluorouracil, up to a target dose of 200 mg/m^2/day, given concurrently with short course radiation followed by neoadjuvant FOLFOX chemotherapy and planned surgical resection for locally advanced rectal cancer. Assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. | Up to 21 days | |
Secondary | Pathological response rate for subjects treated with concurrent 5-FU | To determine the rates of pathologic response for subjects treated with 5-FU together with neoadjuvant, short course pelvic RT. | Up to at least 5 years | |
Secondary | Complete response rate with radiographic imaging prior to surgery | To determine the rate of complete response prior to surgery. | Up to 8 weeks after completion of pre-operative chemotherapy | |
Secondary | Three-year rate of local-regional recurrence for all subjects enrolled on the study | To determine the rates of local-regional recurrence for subjects treated with 5-FU together with neoadjuvant, short course pelvic RT. | 3 years | |
Secondary | Adverse events at any time | To determine the incidence of all toxicity (gastrointestinal and non-gastrointestinal) associated with protocol treatment in the preoperative period, the postoperative period, and therefore assess the tolerability of the combination regimen. | 30 days after surgery | |
Secondary | Three-year rate of disease-free survival for all subjects enrolled on the study | To determine the disease-free survival for subjects treated with 5-FU together with neoadjuvant, short course pelvic RT. | 3 years | |
Secondary | Postoperative morbidity rates | Up to 30 days after surgery | ||
Secondary | Postoperative mortality rates | Up to 30 days after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01987726 -
Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
|
||
Active, not recruiting |
NCT00826540 -
Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
|
Phase 2 | |
Completed |
NCT00025337 -
Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
|
Phase 3 | |
Recruiting |
NCT04642924 -
SGM-101 in Locally Advanced and Recurrent Rectal Cancer
|
Phase 2/Phase 3 | |
Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
Completed |
NCT01217450 -
Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors
|
Phase 1 | |
Completed |
NCT01191684 -
Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer
|
Phase 1 | |
Terminated |
NCT01285102 -
Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer
|
Phase 1 | |
Terminated |
NCT01238965 -
Panobinostat and Fluorouracil Followed By Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Who Did Not Respond to Previous Fluorouracil-Based Chemotherapy
|
Phase 1 | |
Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01037790 -
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
|
Phase 2 | |
Completed |
NCT00551421 -
Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00407654 -
VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer
|
Phase 2 | |
Completed |
NCT00091182 -
Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
|
Phase 2 | |
Terminated |
NCT00052585 -
Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer
|
Phase 2 | |
Completed |
NCT00023933 -
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer
|
Phase 1 | |
Not yet recruiting |
NCT05076305 -
PelvEx 4: Advanced Pelvic Malignancy and the Role of the Multi-disciplinary Team Meeting
|
||
Completed |
NCT01740648 -
Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer
|
Phase 1 | |
Terminated |
NCT00397878 -
AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer
|
Phase 2 | |
Completed |
NCT00100841 -
Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer
|
Phase 2 |