Oxaliplatin, Leucovorin, and Fluorouracil Before and After Radiation Therapy and Surgery in Treating Patients With Rectal Cancer That Can Be Removed by Surgery
- Conditions
- Colorectal Cancer
- Interventions
- Procedure: adjuvant therapyProcedure: neoadjuvant therapyProcedure: therapeutic conventional surgeryRadiation: radiation therapy
- Registration Number
- NCT01263171
- Lead Sponsor
- Cardiff University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neo-adjuvant chemotherapy adjuvant therapy Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy. Neo-adjuvant chemotherapy therapeutic conventional surgery Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy. Neo-adjuvant chemotherapy neoadjuvant therapy Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy. Neo-adjuvant chemotherapy Leucovorin Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy. Neo-adjuvant chemotherapy leucovorin calcium Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy. Neo-adjuvant chemotherapy radiation therapy Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy. Neo-adjuvant chemotherapy fluorouracil Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy. Neo-adjuvant chemotherapy oxaliplatin Neo-adjuvant chemotherapy prior to short course pre-operative radiotherapy followed by adjuvant chemotherapy.
- Primary Outcome Measures
Name Time Method Proportion of patients who commence neoadjuvant chemotherapy and radiotherapy and then undergo surgical resection Two years
- Secondary Outcome Measures
Name Time Method Safety in terms of NCI CTCAE v 4 toxicities up to 30 days postoperatively and late toxicity at 1 year after surgery Two years Complete response Two years Efficacy in terms of down-staging rectal cancer Two years Feasibility in terms of achieved dose intensity for chemotherapy and radiotherapy Two years Local recurrence-free, distant metastasis-free, and overall survival at 1 year after surgery Two years
Trial Locations
- Locations (7)
Walsgrave Hospital
š¬š§Coventry, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
š¬š§Cardiff, Wales, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
š¬š§Leeds, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
š¬š§Preston, England, United Kingdom
Royal Marsden - Surrey
š¬š§Sutton, England, United Kingdom
Christie Hospital
š¬š§Manchester, England, United Kingdom
Glan Clwyd Hospital
š¬š§Rhyl, Denbighshire, Wales, United Kingdom