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Efficacy and Safety Study of Neoadjuvant in Treating Patients With Resectable Local Recurrent Rectal Cancer

NCT01271192 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2011-01-06

No results posted yet for this study

Summary

RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy is still unknown.

PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.

Conditions

Interventions

PROCEDURE

surgical resection and adjuvant therapy

Postoperative: Drug: fluorouracil Given IV continuously, Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks

PROCEDURE

Neoadjuvant followed by operation

Preoperative: Drug: fluorouracil Given IV continuously,Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks Postoperative: Drug: fluorouracil Given IV continuously,Irinotecan Given IV

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Second Military Medical University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ping Lan, M.D. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT01271192 on ClinicalTrials.gov