Combination Chemotherapy and Radiation Therapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and leucovorin,
      work in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
      Giving more than one drug (combination chemotherapy) together with radiation therapy may kill
      more tumor cells.

      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
      with radiation therapy works in treating patients with recurrent metastatic colorectal
      cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the response rate in patients with recurrent metastatic colorectal cancer
           treated with neoadjuvant oxaliplatin, fluorouracil, and leucovorin calcium followed by
           radiotherapy and concurrent fluorouracil and oxaliplatin.

      Secondary

        -  Determine the overall survival and disease-free survival of patients treated with this
           regimen.

        -  Determine the primary site of recurrence and time to recurrence in patients treated with
           this regimen.

        -  Determine quality of life of patients treated with this regimen.

      OUTLINE: This is a nonrandomized, open-label, multicenter study.

        -  Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours and leucovorin
           calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously
           over 46 hours beginning day 1. Treatment repeats every 14 days for 4 courses in the
           absence of disease progression or unacceptable toxicity. Two to 5 weeks later, patients
           with stable or responding disease proceed to chemoradiotherapy.

        -  Chemoradiotherapy: Patients receive fluorouracil IV continuously 5 days a week for 5
           weeks and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29. Patients also undergo
           radiotherapy 5 days a week for 5 weeks beginning on day 1.

      Quality of life is assessed at baseline, 1 week after the completion of neoadjuvant
      chemotherapy, on days 15, 30, and 42 of chemoradiotherapy, and at 1 and 2 months after the
      completion of study treatment.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
    

Intervention name(s): fluorouracil; leucovorin calcium; oxaliplatin; neoadjuvant therapy
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Calcium; Levoleucovorin
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the colon; adenocarcinoma of the rectum; stage IV colon cancer; stage III colon cancer; stage III rectal cancer; stage IV rectal cancer