Radiation Therapy With Either Capecitabine or Fluorouracil Before Surgery in Treating Patients With Resectable Rectal Cancer (NSABP-R-04)

Official Title

Phase III Randomized Study of Preoperative Capecitabine and Radiation Therapy Versus Fluorouracil and Radiation Therapy in Patients With Resectable Rectal Cancer

Summary:

RATIONALE: Drugs used in chemotherapy, such as capecitabine, fluorouracil, and oxaliplatin work in different ways to stop tumour 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 Description

Primary Outcome:

  • Loco-regional disease control as assessed by evidence of tumour at 3 years
Secondary Outcome:
  • Clinical complete response as assessed by digital rectal exam and sigmoidoscopy or proctoscopy at time of definitive analysis
  • Pathologic complete response as assessed by gross and microscopic exam of surgical specimens at time of definitive analysis
  • Sphincter-saving surgery at time of definitive analysis
  • Survival as measured by deaths from any cause at time of definitive analysis
  • Disease-free survival as assessed by recurrence, second primary cancer, or death from any cause at time of definitive analysis
  • Tissue biomarkers as assessed by analysis of tumor tissue using current biotechnology after definitive analysis
  • Quality of life as assessed by FACT-C trial outcome index and EORTC CR38 after definitive analysis
  • Neurotoxicity as assessed by FACT-NTX scale after definitive analysis
  • Symptoms as assessed by fluoropyrimidine symptom scale adapted from SWOG after definitive analysis
  • Vitality as assessed by SF-36 vitality scale after definitive analysis
  • Convenience of care as assessed by NSABP C-06 convenience of care scale adapted from ECOG after definitive analysis

OBJECTIVES:

Primary

  • Compare the rate of local-regional relapse in patients with resectable rectal cancer treated with chemoradiotherapy comprising radiation therapy and either capecitabine or fluorouracil with or without oxaliplatin.

Secondary

  • Compare the rate of clinical complete response in patients treated with these regimens.
  • Compare the rate of pathologic complete response in patients treated with these regimens.
  • Determine the increase in the number of patients who are able to undergo sphincter-saving surgery after treatment with these regimens.
  • Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens.
  • Compare preoperative quality of life (QOL) of patients treated with oral capecitabine versus continuous infusion with fluorouracil.
  • Determine the impact of oxaliplatin on neurotoxicity in patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the convenience of care in patients treated with these regimens.
  • Determine the impact of the type of surgical management on QOL at 1 year postoperatively in these patients.

OUTLINE: This is a randomized, multicentre study. Patients are stratified according to participating centre, gender, clinical tumour stage (stage II vs stage III), and surgical intent (sphincter saving vs non-sphincter saving). Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive fluorouracil IV continuously and undergo radiation therapy once daily 5 days a week for 5-6 weeks.
  • Arm II: Patients receive fluorouracil and undergo radiation therapy as in arm I. Patients also receive oxaliplatin IV over 1 hour once weekly for 5 weeks.
  • Arm III: Patients receive oral capecitabine twice daily and undergo radiation therapy once daily 5 days a week for 5-6 weeks.
  • Arm IV: Patients receive capecitabine and undergo radiotherapy as in arm III. Patients also receive oxaliplatin as in arm II.

Within 6-8 weeks after the completion of chemoradiotherapy, patients with responding or stable disease undergo surgery. Patients with progressive disease are treated at the discretion of the investigator and continue to be followed.

Quality of life is assessed at baseline, at completion of chemoradiotherapy, and at 1 year after surgery.

After completion of study treatment, patients are followed every 6 months for 5 years.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society

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