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Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer

NCT00421824 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2011-01-04

No results posted yet for this study

Summary

Primary:

* To assess complete pathological response rate of both strategies.

Secondary:

* Safety profile
* To assess downstaging rate of both strategies.
* To compare relative dose intensity of oxaliplatin and capecitabine of both strategies
* To compare time to progression and overall survival of both strategies.

Conditions

  • Rectal Neoplasms

Interventions

DRUG

Oxaliplatin, capecitabine

OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery

DRUG

Oxaliplatin, capecitabine

XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.

Sponsors & Collaborators

Principal Investigators

  • José Mª Taboada, Dr. · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Spain

Study Locations

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Entities

Companies

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 NCT00421824 on ClinicalTrials.gov