A Phase II/III Trial of Neoadjuvant FOLFOX With Selective Use of Combined Modality Chemoradiation Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection With Total Mesorectal Excision (PROSPECT)
A Phase II/III Trial of Neoadjuvant FOLFOX With Selective Use of Combined Modality Chemoradiation Versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection With Total Mesorectal Excision (PROSPECT)
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 surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.
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 supportive care while on this study.
OBJECTIVES:
Primary
Secondary
Event monitoring of patients will continue up to 8 years post randomization.
Registration Inclusion Criteria:
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.
The following laboratory values obtained ≤ 28 days prior to registration:
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 Criteria:
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.
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.
Jonesboro, Arkansas 72401, United States
Burbank, California 91505, United States
Cameron Park, California 95682, United States
Roseville, California 95661, United States
Sacramento, California 95817, United States
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Highland Park, Illinois 60035, United States
Highland Park, Illinois 60035, United States
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Milford, Massachusetts 01757, United States
South Weymouth, Massachusetts 02190, United States
Brownstown, Michigan 48183, United States
East China Township, Michigan 48054, United States
Grosse Pointe Woods, Michigan 48236, United States
Macomb, Michigan 48044, United States
Rochester Hills, Michigan 48309, United States
Warren, Michigan 48093, United States
West Branch, Michigan 48661, United States
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