Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer


About this study

RATIONALE: Drugs used in chemotherapy 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. Chemoradiotherapy (combining chemotherapy with radiation therapy) before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any remaining tumor cells.

PURPOSE: This randomized phase II trial is studying two different regimens of neoadjuvant chemoradiotherapy and adjuvant chemotherapy and comparing how well they work in treating patients who are undergoing surgical resection for locally advanced rectal cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Disease Characteristics:

  • Diagnosis of adenocarcinoma of the rectum

    • Clinical stage T3 or T4 disease by endorectal ultrasound or physical examination (for T4 lesions only)
    • Tumor originating at or below 12 cm from the anal verge
    • No extension of disease into the anal canal
  • No evidence of distant metastases
  • No synchronous primary colon carcinomas except T1 lesions
  • Potentially resectable en bloc disease

Patient Characteristics:

  • Age
    • 18 and over
  • Performance status
    • Zubrod 0-2
  • Life expectancy
    • Not specified
  • Hematopoietic
    • Absolute neutrophil count > 1,500/mm^3
    • Platelet count > 100,000/mm^3
  • Hepatic
    • AST (aspartate aminotransferase) < 2.5 times upper limit of normal (ULN)
    • Alkaline phosphatase < 2.5 times ULN
    • Bilirubin ≤ 1.5 times ULN
    • No known uncontrolled coagulopathy
  • Renal
    • Creatinine clearance > 50 mL/min
  • Cardiovascular
    • No congestive heart failure
    • No symptomatic coronary artery disease
    • No uncontrolled cardiac arrhythmias
    • No myocardial infarction within the past year
    • No other clinically significant cardiac disease
  • Other
    • Not pregnant or nursing
    • Negative pregnancy test
    • Fertile patients must use effective contraception during and for 30 days after completion of study treatment
    • No concurrent serious uncontrolled infection
    • No malabsorption syndrome
    • No lack of physical integrity of the upper gastrointestinal tract
    • No evidence of uncontrolled seizures, central nervous system (CNS) disorders, or psychiatric disability that, judged by the investigator, is clinically significant, precludes giving informed consent, or interferes with compliance of oral drug intake
    • No other malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast
    • No other serious uncontrolled medical condition that would preclude study participation

Prior Concurrent Therapy:

  • Biologic therapy
    • No concurrent routine prophylactic filgrastim (G-CSF)
  • Chemotherapy
    • No prior anticancer chemotherapy
  • Endocrine therapy
    • Not specified
  • Radiotherapy
    • No prior radiotherapy to the pelvis
    • No concurrent intensity-modulated radiotherapy
  • Surgery
    • More than 4 weeks since prior major surgery
  • Other
    • More than 4 weeks since prior participation in another clinical trial
    • No concurrent cimetidine
    • No concurrent sorivudine or brivudine

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Mankato, Minn.

Mayo Clinic principal investigator

Mohammad Ranginwala, M.B.B.S.

Closed for enrollment

Contact information:

Research Information Center


More information


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