- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01047969
Avoiding Surgery in Rectal Cancer After Pre-Operative Therapy
June 12, 2019 updated by: Ann Gandolfi, Royal Marsden NHS Foundation Trust
Non-Operative Treatment for Rectal Cancer Following Complete Response to Neo-Adjuvant Therapy
The objective of Timing and Deferral of Rectal Surgery Following a Continued Response to Pre-operative CRT study is to establish the time to maximum tumour response following CRT, and to investigate whether surgery can be safely avoided within the tight framework of the trial follow-up protocol in a small group of patients where the cancer becomes undetectable by imaging modalities.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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 monitored within the framework of the trial follow-up protocol.
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- Royal Marsden NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Two years post end of chemoradiotherapy
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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
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Two years post end of chemoradiotherapy
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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The time to the first diagnosis of lymph node or other distant disease, confirmed via PET/CT, MRI, CT or pathology
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Time to maximal tumour response after CRT
Time Frame: The time when tumour regressed to its minimum thickness and when MRI
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The time when tumour regressed to its minimum thickness and when MRI
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Time to local re-growth
Time Frame: The time until the first recorded increase in Mandard grade, or tumour thickness or length, on MRI
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The time until the first recorded increase in Mandard grade, or tumour thickness or length, on MRI
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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
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At the end of the study - all patients who had surgery for progression of local disease
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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).
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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).
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Quality of Life including long-term bowel, urinary and sexual function
Time Frame: 10 years after registration, or five years post-surgery.
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10 years after registration, or five years post-surgery.
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To correlate the expression of biological markers which may predict for pathological complete response with progression free survival
Time Frame: End of study
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End of study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2006
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
June 1, 2019
Study Registration Dates
First Submitted
January 12, 2010
First Submitted That Met QC Criteria
January 12, 2010
First Posted (Estimate)
January 13, 2010
Study Record Updates
Last Update Posted (Actual)
June 13, 2019
Last Update Submitted That Met QC Criteria
June 12, 2019
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2759
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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