This trial is active, not recruiting.

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
Treatment patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Phase phase 2
Sponsor Royal Marsden NHS Foundation Trust
Start date October 2009
End date June 2015
Trial size 237 participants
Trial identifier NCT01037049, CCR3227


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
(No Intervention)
Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy
Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy

Primary Outcomes

The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI].
time frame: 6-12 weeks

Secondary Outcomes

Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI].
time frame: 3 months
Difference in proportion of patients in each arm undergoing sphincter saving surgery.
time frame: 3 months
Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity.
time frame: 3 months
An analysis will also be undertaken using multivariate and linear regression analysis to evaluate the association of ypT and ypN stage as a potential independent predictors of SUV (max) baseline and after radiotherapy (pre-surgery) in the two arms.
time frame: 3 months
Local and distant recurrence rates.
time frame: 5 years
Radiotherapy related toxicity rates.
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?
Principal investigator Diana Tait
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Royal Marsden NHS Foundation Trust.