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Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks

NCT01037049 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2018-09-17

No results posted yet for this study

Summary

The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks.

Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.

Conditions

  • Adenocarcinoma of the Rectum
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Neoplasms, Glandular and Epithelial
  • Neoplasms by Histologic Type
  • Neoplasms
  • Neoplasms, Cystic, Mucinous, and Serous
  • Colorectal Neoplasms
  • Intestinal Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Neoplasms by Site
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Intestinal Diseases
  • Rectal Diseases

Interventions

OTHER

Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Diana Tait · Royal Marsden NHS Foundation Trust

  • Gina Brown · Royal Marsden Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-16
Primary Completion
2014-12-08
Completion
2019-12-08

Countries

  • Brazil
  • Canada
  • Cyprus
  • United Kingdom

Study Locations

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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 NCT01037049 on ClinicalTrials.gov