NL-OMON52486
Recruiting
Phase 2
eoadjuvant treatment in rectal cancer with radiotherapy followed by atezolizumab and bevacizumab (TARZAN-trial) - Neoadj treatment in rectalcancer with RT,atezo & beva (TARZAN)
ederlands Kanker Instituut0 sites38 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ederlands Kanker Instituut
- Enrollment
- 38
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Signed informed consent form
- •\- Age \>\=18 years
- •\- Histologically confirmed adenocarcinoma of the rectum, and known
- •microsatellite stability status
- •\- Patients with intermediate risk rectal cancer (cT1\-3N1 or cT3c/dN0 MRF\-) or
- •low risk rectal cancer (cT1\-3bN0 MRF\-) in patients who wish to pursue organ
- •preservation
- •\- No signs of distant metastases on CT of thorax and abdomen, MRI pelvis \< 4
- •weeks to inclusion
- •\- Patients must be willing to undergo proctoscopy and biopsies prior to start
Exclusion Criteria
- •\- Clinical symptoms or radiological suspicion of perforation
- •\- Other malignancies within 3 years prior to registration in the study with
- •the exception of those with a negligible risk of metastasis or death , or
- •treated with expected curative outcome
- •\- Prior radiation therapy within 30 days prior to C1D1 and/or persistence of
- •radiation\-related adverse effects or previous radiation therapy preventing
- •5x5Gy as specified in this study
- •\- Prior allogeneic bone marrow transplantation or solid organ transplant for
- •another malignancy in the past
- •\- Spinal cord compression not definitively treated with surgery and/or
Outcomes
Primary Outcomes
Not specified
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