Avoiding Surgery in Rectal Cancer After Pre-Operative Therapy

Launched by ROYAL MARSDEN NHS FOUNDATION TRUST · Jan 12, 2010

Keywords

ClinConnect Summary

The study uses MRI in combination with FDG-PET CT and clinical examination (tri-modality assessment) to assess for a continued incremental response to CRT. Surgery is NOT withheld from patients entering this study. Indeed, surgery is an option at each stage of patient follow-up and is a crucial component of a patient's treatment pathway should no further regression of disease be detected through stringent follow-up. If a status of 'no detectable disease' by serial MRI, CT-PET and clinical assessment is achieved and the patient wishes not to have surgery, they will continue to be carefully m...

Gender

ALL

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