Actively Recruiting
Watch and Wait as Treatment for Patients With Rectal Cancer
Led by Sahlgrenska University Hospital · Updated on 2023-11-07
400
Participants Needed
2
Research Sites
621 weeks
Total Duration
On this page
Sponsors
S
Sahlgrenska University Hospital
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
A national cohort study with all patients scheduled for neoadjuvant treatment with (chemo)radiotherapy or short course radiotherapy with delayed surgery 6-8 weeks) for rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and patients that have been offered short course raditotherapy with delayed surgery due to various reasons). The tumours are positioned midrectal or low and are palpable with the finger. The patients offered this treatment after recommendations on their local multidisciplinary tumour board will be will be informed and offered to participate in the study. Patients scheduled for short course radiotherapy with immediate surgery cannot be included.
CONDITIONS
Official Title
Watch and Wait as Treatment for Patients With Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with palpable rectal cancer staged cT4bNX/anycTanycN with positive mesorectal fascia or lateral lymph nodes on MRI
- Patients appropriate for 5x5 Gy radiotherapy and 6-8 weeks delay before surgery
- Patients scheduled for neoadjuvant therapy according to the Swedish National Program for rectal cancer
- Patients who achieve complete response after neoadjuvant treatment can enter the Watch and Wait protocol
- Midrectal or low rectal cancers that are palpable
- Patients receiving (chemo)radiotherapy in the neoadjuvant setting included for biopsy substudy
You will not qualify if you...
- No informed consent received
- Rectal cancer not palpable on digital exam (10-15 cm) during rectal examination
- Contraindications for MRI such as incompatible metallic implants or claustrophobia
- Patients scheduled for short course radiotherapy with immediate surgery
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, Sweden, SE 416 85
Actively Recruiting
2
Karolinska Institutet
Stockholm, Sweden
Actively Recruiting
Research Team
E
Eva Angenete, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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