Trial Information
Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
The proportion of patients downstaged by T stage will be expressed as a percentage with 95% confidence interval (95% CI) for each treatment arm and compared between the two arms using the Fisher's exact test.
Outcome Time Frame:
6-12 weeks
Safety Issue:
No
Principal Investigator
Diana Tait
Investigator Role:
Principal Investigator
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United Kingdom: Research Ethics Committee
Study ID:
CCR3227
NCT ID:
NCT01037049
Start Date:
October 2009
Completion Date:
February 2012
Related Keywords:
- Adenocarcinoma of the Rectum
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Rectal Neoplasms