None listed
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of a ‘wait and watch’ strategy in patients with rectal cancer who have completed chemoradiotherapy. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with advanced rectal cancer and will be undergoing chemoradiotherapy. Study details After chemoradiotherapy you will be reviewed for any evidence of cancer, through physical exams, imaging and sigmoidoscopy. If there is evidence of cancer you will have surgery to remove this cancer. If there is no evidence of cancer you will not have surgery but instead be followed up at set time points over 5 years, having further imaging, physical exams blood tests and sigmoidoscopies. it is hoped that this research will provide support for the pathway of not conducting surgery on patients who have no evidence of cancer after their chemoradiotherapy.
Interventions
Patients will complete chemoradiation and then based on response (complete response or other) they will be allocated to one of the two study cohorts; follow up with MRI scans (complete responders -considered the intervention arm) or surgery (other).
The surgery is considered the standard arm.
For patients whom are complete responders and go onto the MRI arm, they will not receive surgery. Instead they will be followed up with clinical assessments and sigmoidoscopy, 3-monthly for the first two ye
Patients will complete chemoradiation and then based on response (complete response or other) they will be allocated to one of the two study cohorts; follow up with MRI scans (complete responders -considered the intervention arm) or surgery (other). The surgery is considered the standard arm. For patients whom are complete responders and go onto the MRI arm, they will not receive surgery. Instead they will be followed up with clinical assessments and sigmoidoscopy, 3-monthly for the first two years, then 6-monthly in years 3-5; CT scans at 6, 12, 24, 36, 48 and 60 months; MRI and blood tests every 3 months in the first year then 6-monthly in years 2-5.
Sponsors
Southern Adelaide Local Health Network Inc
Study design
Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. Biopsy proven locally advanced rectal adenocarcinoma: o Locally advanced disease defined as: T3 AND N0-2, T1-2 AND N1-2 [Based on AJCC UICC 2017] o Locally advanced disease defined by the presence of EMVI on MRI, regardless of T or N stage. 3. Subject to undergo Long Course Neoadjuvant Chemo-Radiotherapy based on a multidisciplinary meeting recommendation 4. Considered suitable for long course pelvic radiation therapy 5. Considered suitable for surgery 6. Considered suitable for MRI 7. Willing and able to comply with all study requirements, including treatment and follow up assessments 8. Signed, written informed consent.
Exclusion criteria
1. Presence of metastatic disease (M1) 2. T4 disease based on AJCC 2017 3. Local recurrence of previously treated rectal cancer 4. Previous pelvic radiotherapy 5. Contraindication to fluoropyrimidine chemotherapy 6. History of another malignancy: a. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment. 7. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the chemoradiation with reasonable safety 8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol including chemoradiation and/or follow-up schedule. 9. Pregnancy or lactation.
Outcome results
None listed