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A Study of Radiotherapy in Rectal Cancer Using Oxaliplatin, Capecitabine With or Without Cetuximab

NCT00795301 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2014-01-14

No results posted yet for this study

Summary

Primary Objectives To estimate the pathological complete response rate following neoadjuvant radiotherapy with concurrent capecitabine and oxaliplatin, with or without cetuximab based on the KRAS mutation status in rectal cancer.

Secondary Objectives

1. To evaluate the incidence of grade 3-4 toxicities with each of the two neoadjuvant regimens and during the 30-day post-operative period.
2. To estimate the clinical tumour response rate and sphincter preservation rate with each of the two neoadjuvant regimens.
3. To correlate EGRF gene amplification with pathological response rate in those treated with cetuximab.
4. To estimate the pattern of failure.
5. To establish an annotated tissue library with samples being obtained prior to therapy and following therapy (at the time of surgery).

Conditions

Interventions

DRUG

Capecitabine, Cetuximab, Oxaliplatin

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Wei Peng Yong, MRCP, MB ChB · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2014-12-31

Countries

  • Singapore

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00795301 on ClinicalTrials.gov