Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on MRI
- Rectal tumor at baseline which would be considered to require complete TME
- No evidence of distant metastases
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- Age ≥ 18 years The minimum legal age of consent for select Canadian provinces is 19
- No active infections requiring systemic antibiotic treatment (oral antibiotics are
acceptable at the discretion of the treating physician)
- ECOG Performance status 0-2
- Women with childbearing potential (WOCBP) who are negative for pregnancy test (urine
or blood) and who agree to use effective contraceptive method. A woman of
childbearing potential is defined of one who is biologically capable of becoming
pregnant. Reliable contraception should be used from trial screening and must be
continued throughout the study.
- Patients must read, agree to, and sign a statement of Informed Consent prior to
participation in this study. Patients who do not read or understand English are
eligible and may be consented according to institutional and federal regulations.
- ANC > 1.5 cells/mm3, HGB > 8.0 gm/dl, PLT > 150,000/mm3 total bilirubin ≤ 1.5 x ULN
(except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x
ULN), AST≤ 3 x ULN, ALT ≤ 3 x ULN.
Exclusion Criteria:
- Recurrent rectal cancer
- Primary unresectable rectal cancer. A tumor is considered unresectable when invading
adjacent organs and an en block resection will not achieve negative margins.
- Creatinine level greater than 1.5 times the upper limit of normal.
- Patients who have received prior pelvic radiotherapy.
- Patients who are unable to undergo an MRI.
- Patients with a history of any arterial thrombotic event within the past 6 months.
This includes angina (stable or unstable), MI, TIA, or CVA.
- Patients with a history of venous thrombotic episodes such as deep venous
thrombosis, pulmonary embolus occurring more than 6 months prior to enrollment may
be considered for protocol participation, provided they are on stable doses of
anticoagulant therapy. Similarly, patients who are anticoagulated for atrial
fibrillation or other conditions may participate, provided they are on stable doses
of anticoagulant therapy.
- Other Anticancer or Experimental Therapy. No other experimental therapies (including
chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene
therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease
inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody or other experimental
drugs) of any kind are permitted while the patient is receiving study treatment.
- WOCBP who are unwilling or unable to use an acceptable method of avoiding pregnancy
for the entire study period.
- Women who are pregnant or breast-feeding.
- Patients with any other concurrent medical or psychiatric condition or disease
which, in the investigator's judgment, would make them inappropriate candidates for
entry into this study.
- Patients with a history of a prior malignancy within the past 5 years, except for
adequately treated basal cell or squamous cell skin cancer or in situ cervical
cancer.