Status:
ACTIVE_NOT_RECRUITING
PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Canadian Cancer Trials Group
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surg...
Detailed Description
OUTLINE: This is a multicenter, phase II/III study. Patients are stratified according to ECOG performance status (0 or 1 vs 2) and randomized to 1 of 2 treatment regimens. Patients will receive full s...
Eligibility Criteria
Inclusion
- Registration
- Age ≥ 18 years at diagnosis
- Diagnosis of rectal adenocarcinoma
- Radiologically measurable or clinically evaluable disease as defined in the protocol
- ECOG Performance Status (PS): 0, 1 or 2
- For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection
- Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
- Primary surgeon is credentialed or is willing to be credentialed in Total Mesorectal Excision (TME), which entails submission of photos of a single TME specimen either before enrolling the first patient or by using the surgeon's 1st accrued case.
- Clinical Stage: T2N1, T3N0, T3N1.
- N2 disease is to be estimated as four or more lymph nodes that are ≥ 10 mm.
- Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT or PET/CT scan of the chest/abdomen/pelvis and either a pelvic MRI or an ultrasound (ERUS). If a pelvic MRI is peformed, it is acceptable to perform CT of the chest/abdomen, ommitting CT imaging of the pelvis.
- The following laboratory values obtained ≤ 28 days prior to registration:
- Absolute neutrophil count (ANC) ≥ 1500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin \> 8.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- SGOT (AST) ≤ 3 x ULN
- SGPT (ALT) ≤ 3 x ULN
- Creatinine ≤1.5 x ULN
- Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
- Patient of child-bearing potential is willing to employ adequate contraception
- Provide informed written consent
- Willing to return to enrolling medical site for all study assessments
- Registration
Exclusion
- Clinical T4 tumors
- Primary surgeon indicates need for abdominoperineal (APR) at baseline
- Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins)
- Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible).
- Chemotherapy within 5 years prior to registration. Hormonal therapy is allowable if the disease free interval is ≥ 5 years.
- Any prior pelvic radiation
- Other invasive malignancy ≤ 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervix.
- Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects.
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
Key Trial Info
Start Date :
June 12 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
1194 Patients enrolled
Trial Details
Trial ID
NCT01515787
Start Date
June 12 2012
End Date
June 30 2024
Last Update
February 2 2024
Active Locations (1073)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Southern Cancer Center PC-Daphne
Daphne, Alabama, United States, 36526
3
Southern Cancer Center PC-Mobile
Mobile, Alabama, United States, 36607
4
Southern Cancer Center PC-Providence
Mobile, Alabama, United States, 36608