Adenocarcinoma, Adenocarcinoma, Mucinous, Adenocarcinoma of the Rectum, Carcinoma, Colorectal Neoplasms, Digestive System Diseases, Digestive System Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Intestinal Diseases, Intestinal Neoplasms, Neoplasms, Neoplasms by Histologic Type, Neoplasms by Site, Neoplasms, Cystic, Mucinous, and Serous, Neoplasms, Glandular and Epithelial, Rectal Diseases
Conditions
Keywords
Rectal Cancer, 6vs12, 6 vs 12, Cancer, CRM, Circumferential Resection Margin, Quality of Life, MRI, Radiology, Abdominoperineal Excision, Anterior Resection, Surgery, Pathology, Radiotherapy
Brief summary
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.
Interventions
OTHERPatients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI]. | 6-12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Difference in proportion of patients in each arm undergoing sphincter saving surgery. | 3 months |
| Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity. | 3 months |
| Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI]. | 3 months |
| Local and distant recurrence rates. | 5 years |
| Radiotherapy related toxicity rates. | 5 years |
| 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. | 3 months |
Countries
Brazil, Canada, Cyprus, United Kingdom
Outcome results
None listed