rectal cancer rectum
Conditions
Interventions
• 5 x 5Gy radiotherapy (RT) followed 3 weeks later by
• 3 x bevacizumab 5mg/kg IV at 2-weekly (q2w) intervals
• 3 x atezolizumab 840mg IV q2w, starting 2 weeks after the first bevacizumab
dose
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 64 Years
Inclusion 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
Exclusion criteria
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 radiation - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures - Uncontrolled tumor pain - Treatment with any investigational agent or approved therapy within 28 days or two investigational agent half-lives (whichever is longer) prior to C1D1 - Prior treatment with CD137 agonists or immune checkpoint blockade therapies - Current or recent (within 10 days of study enrollment) use of acetylsalicylic acid (> 325 mg/day), clopidogrel (> 75 mg/day) or current or recent (within 10 days of C1D1) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical complete and near-complete response rate (cCCR) assessed at week 12 post-RT: • Complete response is defined as lack of any visible lesion at rectoscopy* (except a flat scar, telangiectasia or whitening of the mucosa; and lack of absence of any residual tumor in the primary site and draining lymph nodes on imaging with MRI including DWI • Near complete response is defined as only a small flat ulceration on endoscopy and/or a small residual focus on DWI, with otherwise no signs of residual tumor. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety: incidence and severity of AEs (with severity determined according to NCI CTCAE v4.03), vital signs and clinical laboratory test results. • Pre-operative treatment-related complications leading to delays in systemic treatment and/or surgery (excluding non-treatment-related and logistical reasons). • Relapse-free survival (RFS), defined as the time from study enrolment to disease recurrence or disease-related death during follow-up • Local recurrence rate (LRR) at 1 year follow-up • Proportion of patients who undergo organ preserving treatment • Pathological complete and near-complete response (pCR), defined as Mandard TRG 1-2, if available • Radiological tumor regression using MRI (ESGAR consensus guidelines) | — |
Countries
Netherlands
Outcome results
None listed