Erbitux in preoperative chemo-radiotherapy followed by excisional surgery

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Rectum; Cancer; Rectal cancer

• Registration Number: ISRCTN11319909
• Lead Sponsor: niversity College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-12
• Study Completion: 2014-04-01
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Adenocarcinoma of the rectum (within 15 cm of anal verge)
2. Tumour tissue available for testing of epidermal growth factor receptor (EGFR) status
3. Indication for pre-operative chemoradiotherapy with R0 resection unlikely
4. Fit for chemotherapy
5. Written informed consent for both treatment and biopsies
6. Male and female, lower age limit of 18 years

Exclusion Criteria

1. Previous radiotherapy to the pelvis
2. Previous pelvic resectional surgery (cystectomy, hysterectomy)
3. Previous chemotherapy or radiation for rectal cancer
4. Previous chemotherapy for metastatic disease
5. Patients who have very significant small bowel delineated within the radiation fields
6. Currently enrolled in any other treatment trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Acute Toxicity (Grade 3 or above in defined DLT)<br>2. Compliance with the planned dose of radiotherapy<br><br>Assessed after the patient has had surgery.

Secondary Outcome Measures

Name	Time	Method
1. Histopathological downstaging (yPT0,T1,T2 N0)<br>2. Histologically confirmed (R0) resection<br><br>Assessed after the patient has had surgery.