Status:
TERMINATED
"Watch and Wait" After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
Lead Sponsor:
Helse Stavanger HF
Collaborating Sponsors:
University Hospital of North Norway
St. Olavs Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Among patients treated for locally advanced rectal cancer with neo-adjuvant radio-chemotherapy, about 15% will have complete clinical response in terms of no visible tumor or ulcerations on the site o...
Eligibility Criteria
Inclusion
- Histologically verified adenocarcinoma of the rectum within 15 cm from the anal verge measured by rigid proctoscopy
- Patients who have completed neoadjuvant treatment according to national guidelines for rectal cancer, i.e., radiotherapy or chemo-radiotherapy (at least 40 Gy) or short-course radiotherapy combined with chemotherapy
- Patients aged ≥18 years of age are eligible for inclusion. However, patients aged ≤40 years are recommended to undergo surgery on the theoretical base of a possibly more aggressive tumour disease in this age group, and will be asked to participate in the study by consenting to recording of data. Those patients who insist on W\&W approach after careful consideration and well-documented informed consent are eligible for entering the W\&W protocol.
- Given informed consent
- Stage I-III rectal cancer; however, patients with limited liver metastases who undergo primary liver surgery as part of a "liver first" treatment approach may be included
Exclusion
- Patients without cCR
- Patients unable to give informed consent
- Patients with short course radiotherapy (5x5 Gy) without additional chemotherapy, or patients receiving less than 40 Gy in long course CRT
- Patients with cCR but with increasing tumour growth on MRI after preoperative treatment
- Patients with metastatic disease at the time of diagnosis with the exception of those who are eligible for "liver first" treatment approach as part of an intention to cure approach.
- Patients previously diagnosed and treated for malignant disease in the pelvic region with radio- or chemoradiotherapy
- Other circumstances that may interfere with successful participation in the W\&W protocol
Key Trial Info
Start Date :
January 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03402477
Start Date
January 10 2018
End Date
April 19 2024
Last Update
April 24 2024
Active Locations (7)
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1
Haukeland University Hospital
Bergen, Norway
2
Sørlandet Hospital Kristiansand
Kristiansand, Norway
3
Akershus University Hospital
Lørenskog, Norway, 1478
4
Oslo University Hospital
Oslo, Norway