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Avoiding Surgery in Rectal Cancer After Pre-Operative Therapy

NCT01047969 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2019-06-13

No results posted yet for this study

Summary

The objective of Timing and Deferral of Rectal Surgery Following a Continued Response to Pre-operative CRT study is to establish the time to maximum tumour response following CRT, and to investigate whether surgery can be safely avoided within the tight framework of the trial follow-up protocol in a small group of patients where the cancer becomes undetectable by imaging modalities.

Conditions

  • Rectal Adenocarcinoma

Interventions

DRUG

Adjuvant Chemotherapy

If after MRI + FDG-PET 8 weeks post CRT the patient shows no visible tumour or further regression adjuvant chemotherapy will be considered.

PROCEDURE

Surgery

If after MRI + FDG-PET 8 weeks post CRF no further regression or growth of disease occurs the patient will be referred for surgery.

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-06
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • 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 NCT01047969 on ClinicalTrials.gov