Chemotherapy or no chemotherapy in clear margins after neoadjuvant chemoradiation in locally advanced rectal cancer. A randomised phase III trial of control vs capecitabine plus oxaliplatin.

Phase 3

Completed

• Conditions: ocally advanced rectal cancer; Cancer; Rectal cancer

• Registration Number: ISRCTN59865116
• Lead Sponsor: niversity College London (UK)

Brief Summary

2007 Results article in http://www.ncbi.nlm.nih.gov/pubmed/17434299 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-11-11
• Study Completion: 2007-12-01
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

1. Patients aged 18 and over
2. Histologically proven locally advanced rectal carcinoma
3. Pre-operative fluoropyrimidine based chemoradiation, minimum dose 45 Gy
4. Complete resection of primary tumour with clear margins
5. Able to start treatment within 12 weeks of surgery
6. Normal Full Blood Counts (FBCs), Urea and Electrolytes (U+Es) and Liver Function Tests (LFTs)
7. Creatinine clearance more than or equal to 50 ml/min
8. World Health Organisation performance status less than two
9. Patient consent

Exclusion Criteria

1. Unsuitable for chemotherapy:
a. known DPD deficiency
b. hypersensitivity to platinum
c. not recovered from surgery
d. peripheral neuropathy
e. moderate or severe renal impairment
f. malabsorbtion syndrome
2. Prior oxaliplatin, irinotecan and mitomycin
3. Taking warfarinor antiviral agents
4. Previous malignancies or serious uncontrolled medical conditions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Three year disease free survival of 85% power to detect a 10% increase i.e. 40% to 50%.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Overall survival<br> 2. Toxicity<br>