Avoiding Surgery in Rectal Cancer After Pre-Operative Therapy
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
To estimate the percentage of patients who can safely omit surgery, defined as the percentage of patients at two years after end of CRT who have not had surgery and who are in CR (no detectable local disease) [ Time Frame: Two years post end of chemoradiotherapy ]
To prove the safety of deferred surgery, as measured by the percentage of patients who have local failure at two years, where local failure is defined as positive margin status of resected tumour or surgically unsalvageable disease. [ Time Frame: Two years post end of chemoradiotherapy ]
Secondary Outcome Measures :
Time to distant disease [ Time Frame: The time to the first diagnosis of lymph node or other distant disease, confirmed via PET/CT, MRI, CT or pathology ]
Time to maximal tumour response after CRT [ Time Frame: The time when tumour regressed to its minimum thickness and when MRI ]
Time to local re-growth [ Time Frame: The time until the first recorded increase in Mandard grade, or tumour thickness or length, on MRI ]
Percentages of positive margins, and sphincter-preservation rates in patients who have had surgery [ Time Frame: At the end of the study - all patients who had surgery for progression of local disease ]
Progression-free and overall survival [ Time Frame: Measured from the end of CRT (cohort A) or end of adjuvant chemotherapy (cohort B). Surviving patients in continued CR will be censored at the date of last follow-up (clinic visit or imaging). ]
Quality of Life including long-term bowel, urinary and sexual function [ Time Frame: 10 years after registration, or five years post-surgery. ]
To correlate the expression of biological markers which may predict for pathological complete response with progression free survival [ Time Frame: End of study ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age > 18 years
Locally invasive high-risk rectal adenocarcinoma as defined by the presence on MRI of at least one of the following: i) Tumours within 1mm of mesorectal fascia i.e. circumferential resection margin threatened or involved ii)T3 tumours at/below levators iii)Tumours extending ≥5mm into peri-rectal fat iv)T4 tumours (including the involvement of bladder or vagina if surgical resection is possible with clear margins) v)Presence of extra-mural venous invasion (primary tumour is therefore at least T3) vi)T2 N0/1/2 tumours requiring Abdomino-Perineal Excision, within 1mm of mesorectal fascia i.e. circumferential resection margin threatened or involved
The absence of malignant pelvic side-wall disease, local recurrence (either after TME or wide local excision) or metastatic disease
Completion of pre-operative long-course CRT
No viable disease seen at MRI performed 4 weeks after long-course CRT, confirmed at 8 week MRI
Evidence of partial response of rectal tumour to pre-operative long-course CRT at 4 week MRI which continues to show an incremental response at 8 week MRI.
Histological diagnosis of adenocarcinoma of rectum.
WHO performance status 0, 1 or 2.
No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required.
Informed written consent
Age < 18 years.
Absence of concomitant chemotherapy.
RT dose below 50Gy.
Stable disease at 4 week MRI.
Disease that demonstrates a partial response at 4 week MRI but shows no evidence of an incremental response at 8 week MRI.
Pregnancy or breast feeding
Short course pre-operative radiotherapy
Previous pelvic radiotherapy
Medical or psychiatric conditions that compromise the patient's ability to give informed consent
Any contra-indication to MRI scanning, eg Cardiac Pacemaker or Hip prosthesis.
Any patients within the EXPERT-C trial.
Tumours which are mucinous (>50% mucin seen on MRI), as these are more likely to be PET negative