Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 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.
Phase
Phase 2/Phase 3
Funding Agency/Sponsor
National Cooperative Group
Disease
Colorectal Cancer
Enrollment Eligibility
Registration Inclusion Criteria:
1. Age ≥ 18 years at diagnosis
2. Diagnosis of rectal adenocarcinoma
3. Radiologically measurable or clinically evaluable disease as defined in the protocol
4. ECOG Performance Status (PS): 0, 1 or 2
5. 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
6. Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy
according to the primary surgeon
7. 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.
8. 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.
9. 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
10. Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing
potential only
11. Patient of child-bearing potential is willing to employ adequate contraception
12. Provide informed written consent
13. Willing to return to enrolling medical site for all study assessments
Registration Exclusion Criteria:
1. Clinical T4 tumors
2. Primary surgeon indicates need for abdominoperineal (APR) at baseline
3. 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)
4. Tumor is causing symptomatic bowel obstruction (patients who have had a temporary
diverting ostomy are eligible).
5. Chemotherapy within 5 years prior to registration. Hormonal therapy is allowable if
the disease free interval is ≥ 5 years.
6. Any prior pelvic radiation
7. 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.
8. 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
9. 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.