Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer
- Conditions
- Rectal Cancer
- Registration Number
- NCT00972881
- Lead Sponsor
- University College, London
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy, cetuximab, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I/II trial is studying the side effects of giving capecitabine and irinotecan hydrochloride together with cetuximab and radiation therapy and to see how well it works in treating patients undergoing surgery for locally advanced rectal cancer.
- Detailed Description
OBJECTIVES:
* To assess the downstaging effectiveness and tolerability of neoadjuvant chemoradiotherapy comprising capecitabine, irinotecan hydrochloride, cetuximab, and radiotherapy in patients with locally advanced rectal cancer.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-6 and irinotecan hydrochloride IV over 1 hour once weekly in weeks 2-5. Patients also undergo pelvic radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 in weeks 2-6.
Patients undergo surgery 8 weeks after completion of chemoradiotherapy.
After completion of study treatment, patients are followed up at 6, 12, 24, and 36 months.
Peer Reviewed and Funded or Endorsed by Cancer Research United Kindom (UK).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Histologically confirmed R0 resection rate Week 14 (6 weeks after treatment complete)
- Secondary Outcome Measures
Name Time Method Pathological complete response Week 14 (surgery conducted 6 weeks from end of treatment) Disease-free survival Baseline, week 1- 10, week 12, 14 & then at 6, 12, 24 & 36 months follow up Local failure-free survival Baseline, weeks 1- 10, weeks 12 & 14 then at 6, 12, 24 & 36 months follow up Radiotherapy compliance Weeks 2, 3, 4, 5 & 6 Radiotherapy treatment and dosage is captured on weekly CRFs from week 2-6
Grade 3 or 4 toxicity as assessed by NCI CTCAE v3.0 Baseline, week 1- 10, week 12 & 14 then at 6, 12, 24 & 36 months follow up Adverse events are recorded weekly on CRFs from week 1 of treatment until 4 weeks post treatment, then at 1 month post surgery and specified time points during long term follow up at 6, 12, 24 \& 36 month intervals.
Post-operative morbidity Week 14 Long-term morbidity Week 14, then at 6, 12, 24 & 36 months follow up
Trial Locations
- Locations (5)
Cancer Research UK and University College London Cancer Trials Centre
🇬🇧Rhyl, Denbighshire, Wales, United Kingdom
Yorkshire Regional Clinical Trials & Research Unit
🇬🇧Leeds, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom