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Trial Information

TitleA Clinical Trial Comparing Preoperative Radiation Therapy And Capecitabine With or Without Oxaliplatin With Preoperative Radiation Therapy And Continuous Intravenous Infusion Of 5-Fluorouracil With or Without Oxaliplatin In The Treatment Of Patients With Operable Carcinoma Of The Rectum
Trial IdentifierNCT00058474
SponsorNational Surgical Adjuvant Breast and Bowel Project (NSABP)
  • Richard Hellwig, MD
  • Saint Anne's Hospital  (Recruiting)
Global Trial StatusRecruiting
Study PhasePhase 3

Contact Information


Paulette Manssuer, RN
Saint Anne's Hospital Phone: 508-235-5226 Email: paulette.manssuer@caritaschristi.org

Other Trial Information

Trial Rationale and Purpose

RATIONALE: Drugs used in chemotherapy, such as capecitabine, fluorouracil, and oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: This randomized phase III trial is studying radiation therapy and either capecitabine or fluorouracil with or without oxaliplatin and comparing them to see how well they work when given before surgery in treating patients with resectable rectal cancer. It is not yet known whether radiation therapy and either capecitabine or fluorouracil is more effective with or without oxaliplatin in treating rectal cancer.

Trial Inclusion/Exclusion Criteria


- Diagnosis of adenocarcinoma of the rectum

- Diagnosis obtained within the past 42 days by a biopsy technique which leaves the
major portion of the tumor intact

- Stage II (T_3-4, N_0 [N_0is defined as all imaged lymph nodes < 1.0 cm]) OR stage
III (T_1-4, N_1-2 [with the definition of a clinically positive lymph node being
any node ≥ 1.0 cm]

- Clinically staged by transrectal ultrasound or MRI with endocoil or
endoluminal ultrasound AND CT scan, MRI, or combined PET/CT scan

- Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope

- Distal border of the tumor must be located < 12 cm from the anal verge

- Tumor amenable to curative resection* NOTE: *Curative resection can include pelvic

- No history of invasive rectal malignancy, regardless of disease-free interval

- No other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma,
or cloacogenic carcinoma)

- No synchronous colon cancer

- No clear indication of involvement of the pelvic side walls by imaging

- No evidence of metastatic disease



- 18 and over

Performance status

- ECOG 0-1 OR

- Zubrod 0-1

Life expectancy

- At least 5 years (excluding diagnosis of cancer)


- Absolute neutrophil count ≥ 1,200/mm^3

- Platelet count ≥ 100,000/mm^3


- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2 times ULN

- AST ≤ 2 times ULN*

- No hepatic disease that would preclude study treatment or follow-up

- No uncontrolled coagulopathy

- No history of viral hepatitis or other chronic liver disease NOTE: *If AST is > ULN,
serologic testing for Hepatitis B and C must be performed and results must be


- Creatinine clearance > 50 mL/min

- No renal disease that would preclude study treatment or follow-up


- No cardiovascular disease that would preclude study treatment or follow-up

- No New York Heart Association class III or IV heart disease

- No active ischemic heart disease

- No myocardial infarction within the past 6 months

- No symptomatic arrhythmia

- No uncontrolled hypertension


- Able to take oral medications

- No lack of upper gastrointestinal tract integrity or malabsorption syndrome

- No active inflammatory bowel disease (i.e., patients requiring current medical
interventions or who are symptomatic)


- Not pregnant or nursing

- Fertile patients must use effective contraception

- Patients with prior malignancies, including invasive colon cancer, are eligible
provided they have been disease-free for ≥ 5 years and are deemed by their physician
to be at low risk for recurrence

- No other malignancy within the past 5 years except effectively treated squamous cell
or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or
carcinoma in situ of the colon or rectum

- No other nonmalignant systemic disease that would preclude study therapy or follow-up

- No known hypersensitivity to fluorouracil, capecitabine, or oxaliplatin

- No clinically significant peripheral neuropathy (i.e., neurosensory or neuromotor
toxicity ≥ grade 2)

- No psychiatric or addictive disorders, or other conditions that, in the opinion of the
investigator, would preclude study participation


Biologic therapy

- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)


- No prior pelvic radiotherapy


- See Disease Characteristics


- No prior therapy for this cancer

- More than 4 weeks since prior participation in any investigational drug study

- No concurrent halogenated antiviral agents (e.g., sorivudine or brivudine)

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