NCT01047969

Avoiding Surgery in Rectal Cancer After Pre-Operative Therapy

Non-Operative Treatment for Rectal Cancer Following Complete Response to Neo-Adjuvant Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study uses MRI in combination with FDG-PET CT and clinical examination (tri-modality assessment) to assess for a continued incremental response to CRT. Surgery is NOT withheld from patients entering this study. Indeed, surgery is an option at each stage of patient follow-up and is a crucial component of a patient's treatment pathway should no further regression of disease be detected through stringent follow-up. If a status of 'no detectable disease' by serial MRI, CT-PET and clinical assessment is achieved and the patient wishes not to have surgery, they will continue to be carefully monitored within the framework of the trial follow-up protocol.

Conditions

• Rectal Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-06-06
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2010-01-13
• Last updated: 2019-06-13

Locations

1 site across 1 country: United Kingdom