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

R

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

237 participants in 2 patient groups

Group 1
No Intervention group
Description:
Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy
Group 2
Experimental group
Description:
Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Treatment:
Other: Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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