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

Royal Marsden NHS Foundation Trust

Status and phase

Unknown

Phase 2

Conditions

Gastrointestinal Diseases

Intestinal Diseases

Neoplasms by Site

Neoplasms, Glandular and Epithelial

Digestive System Diseases

Carcinoma

Digestive System Neoplasms

Adenocarcinoma

Gastrointestinal Neoplasms

Neoplasms by Histologic Type

Intestinal Neoplasms

Adenocarcinoma, Mucinous

Neoplasms

Rectal Diseases

Adenocarcinoma of the Rectum

Colorectal Neoplasms

Neoplasms, Cystic, Mucinous, and Serous

Treatments

Other: Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01037049

CCR3227

Details and patient eligibility

About

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.

Enrollment

237 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged > 18
Informed written consent
Histological confirmation of adenocarcinoma of rectum
Undergoing pre-operative radiotherapy/ chemotherapy
Completion of pre-operative treatment

Exclusion criteria

Aged < 18
Absence of pre-operative RT/CT
Medical/ psychiatric conditions that compromise the patients ability to give informed consent
Contra-indications to MRI, i.e. hip prothesis, cardiac pacemaker