Actively Recruiting
Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision
Led by The Netherlands Cancer Institute · Updated on 2023-03-17
168
Participants Needed
7
Research Sites
410 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
C
Catharina Ziekenhuis Eindhoven
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this prospective phase II feasibility study is to evaluate two additional local treatment options in rectal cancer patients with a good clinical response after neoadjuvant (chemo)radiation: contact x-ray brachytherapy versus extension of the waiting interval with or without local excision, and to investigate which rate of organ preservation can be achieved.
CONDITIONS
Official Title
Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma located above the dentate line and within 10 cm of the anal verge
- Received neoadjuvant short-course radiotherapy for intermediate rectal cancer with delayed response evaluation or long-course chemoradiation for locally advanced rectal cancer
- Clinically near-complete response or small residual tumor less than 3 cm
- Both contact x-ray brachytherapy and local excision are technically feasible
- Age over 18 years
- Provided written informed consent
You will not qualify if you...
- Received neoadjuvant or induction chemotherapy prior or adjacent to (chemo)radiation (e.g., Rapido or M1-scheme)
- Radiation dose greater than 50.4 Gy or boost dose on the primary tumor
- Presence of suspicious lymph nodes (yN1/N2) at first response evaluation
- Residual tumor 3 cm or larger or involving over half the circumference of the rectal lumen
- Unable to undergo contact x-ray brachytherapy or local excision
- Cannot tolerate completion or salvage TME surgery due to comorbidity or frailty
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Radbouw University Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Actively Recruiting
2
Catharina Hospital
Eindhoven, North Brabant, Netherlands, 5623EJ
Actively Recruiting
3
Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands, 1066CX
Actively Recruiting
4
Deventer Hospital
Deventer, Overijssel, Netherlands, 7416 SE
Actively Recruiting
5
Isala
Zwolle, Overijssel, Netherlands, 8025 AB
Actively Recruiting
6
Medical Center Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
Actively Recruiting
7
Ijsselland Hospital
Capelle aan den IJssel, South Holland, Netherlands, 2906 ZC
Actively Recruiting
Research Team
B
Barbara M Geubels, MD
CONTACT
B
Brechtje A Grotenhuis, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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