A Stratified Phase II Study of Neoadjuvant Chemotherapy Given Before SCPRT as Treatment for Patients With MRI-Staged Operable Rectal Cancer at High Risk of Metastatic Relapse
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients who commence neoadjuvant chemotherapy and radiotherapy and then undergo surgical resection
Two years
No
Simon Gollins, MD
Principal Investigator
Glan Clwyd Hospital
Medicines and Healthcare products Regulatory Agency United Kingdom:
CDR0000691166
NCT01263171
April 2012
Name | Location |
---|