Oxaliplatin, Leucovorin, and Fluorouracil Before and After Radiation Therapy and Surgery in Treating Patients With Rectal Cancer That Can Be Removed by Surgery
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil,
      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 chemotherapy before surgery may make the tumor smaller and reduce the amount of normal
      tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells
      that remain after surgery.

      PURPOSE: This phase II trial is studying giving oxaliplatin, leucovorin, and fluorouracil
      together, before and after radiation therapy and surgery in treating patients with rectal
      cancer that can be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the feasibility of introducing 8 weeks of neoadjuvant oxaliplatin and
           fluorouracil followed by radiotherapy and immediate surgical resection in patients with
           resectable adenocarcinoma of the rectum.

      Secondary

        -  Determine feasibility of achieving dose intensity for chemotherapy and radiotherapy in
           these patients.

        -  Determine the safety, in terms of NCI CTCAE version 4 toxicities, including
           postoperative complication rate (up to 30 days postoperatively), and late toxicity
           assessment at 1 year following surgery, in these patients.

        -  Determine how active is the neoadjuvant chemotherapy, in terms of down staging the
           rectal cancer, local recurrence-free, distant metastasis-free, and overall survival at 1
           year following surgery in these patients.

      Neoadjuvant therapy: Patients receive oxaliplatin and leucovorin (L-leucovorin or leucovorin
      calcium) IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2. Treatment
      repeats every 2 weeks for up to 4 courses in the absence of disease progression or
      unacceptable toxicity.

      Radiotherapy/Surgery: Beginning 1 week after completion of chemotherapy, patients undergo
      radiotherapy, followed by surgical resection of their primary tumor, within 7-14 days after
      completion of radiotherapy. Between 6-8 weeks following surgery, patients begin adjuvant
      therapy.

      Adjuvant therapy: Patients receive oxaliplatin and leucovorin (L-leucovorin or leucovorin
      calcium) IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2. Treatment
      repeats every 2 weeks for up to 8 courses in the absence of disease progression or
      unacceptable toxicity.

      Blood and biopsy specimens are collected at baseline and periodically for translational
      research studies.

      After completion of study therapy, patients are followed up periodically for 1 year.

      Peer Reviewed and Funded or Endorsed by Cancer Research UK.
    

Intervention name(s): Leucovorin; fluorouracil; leucovorin calcium; oxaliplatin; adjuvant therapy; neoadjuvant therapy; therapeutic conventional surgery; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Procedure; Procedure; Radiation
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the rectum; stage IIIB rectal cancer; stage IIIC rectal cancer