Actively Recruiting
Led by The Netherlands Cancer Institute · Updated on 2023-03-17
168
Participants Needed
7
Research Sites
208 weeks
Total Duration
T
The Netherlands Cancer Institute
Lead Sponsor
C
Catharina Ziekenhuis Eindhoven
Collaborating Sponsor
Researchers are exploring ways to preserve the rectum in patients with rectal cancer who show a good clinical response after neoadjuvant (chemo)radiation. This phase II feasibility study compares two local treatment approaches: contact x-ray brachytherapy versus extending the waiting period with or without local excision. The goal is to determine how often organ preservation can be achieved and to optimize treatment strategies for patients with a near-complete response or small residual tumor. The study includes two experimental groups. In one group, contact x-ray brachytherapy is delivered as three 30 Gy fractions to the tumor within 14 weeks after completing (chemo)radiation, with two-week intervals between doses. Patients are monitored every three months afterward. The other group extends the waiting interval by 6 to 8 weeks after the initial response evaluation, with additional assessments to check for tumor response. Patients showing complete response enter a watch-and-wait approach, while those with small remaining lesions may receive local excision, followed by risk-based recommendations for further treatment. Participants undergo regular clinical, radiological, and endoscopic assessments to monitor tumor response and detect any disease progression. The primary outcome is the rate of successful organ preservation one year after randomization. Secondary outcomes include treatment-related toxicity, postoperative complications, bowel and bladder function, quality of life, tumor regrowth, disease-free survival, and overall survival measured up to five years. An intensive follow-up program supports early detection of recurrence and timely surgical intervention if needed.
CONDITIONS
Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on treatment type
Participants receive neoadjuvant short-course radiotherapy or long-course chemoradiation according to Dutch guidelines before randomization.
Multiple visits as part of standard care
Duration - 1 to 2 weeks
Participants undergo radiological and endoscopic assessment 6-8 weeks after finishing neoadjuvant (chemo)radiation to determine clinical response.
1 visit (in-person)
Duration - Up to 14 weeks after neoadjuvant (chemo)radiation
Participants with a good, but not complete clinical response are randomized to one of two experimental treatment strategies to attempt organ preservation.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive three fractions of contact x-ray brachytherapy, each 30 Gy, with 2-week intervals between fractions.
3 treatment visits (in-person) with 2-week intervals
Duration - 6 to 16 weeks including extended observation and possible local excision
Participants extend the waiting interval by 6-8 weeks after first response evaluation, followed by second or third response assessments. If residual lesion remains, local excision may be performed.
2 to 3 follow-up visits (in-person) including local excision if needed
Duration - Up to 5 years
Participants are monitored with response evaluations every 3 months to detect complete response, treatment failure, or disease progression, with watch-and-wait approach or surgery as needed.
Quarterly visits in the first year, less frequent later
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
B
Barbara M Geubels, MD
B
Brechtje A Grotenhuis, MD, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Barbara M Geubels, Baukelien van Triest, Femke P Peters...
https://pubmed.ncbi.nlm.nih.gov/38159950