Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT01047969
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01047969
Study Brief:
Protocol Section:
NCT01047969