eoadjuvant treatment in rectal cancer with radiotherapy followed by atezolizumab and bevacizumab (TARZAN) - TARZA

Antoni van Leeuwenhoek0 sites38 target enrollmentAugust 29, 2018

Overview

No summary available.

Registry

who.int

Start Date

August 29, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Antoni van Leeuwenhoek

•\- Signed informed consent form
•\- Age \=18 years
•\- Able to comply with the study protocol, in the investigator’s judgment
•\- Histologically confirmed adenocarcinoma of the rectum, and known microsatellite stability status
•\- Patients with intermediate risk rectal cancer (cT1\-3N1 or cT3N0 with extramural invasion \>5 mm, distance to MRF \>1 mm) or
•Low risk distal rectal cancer (cT1\-3N0, extramural invasion tot \=5 mm, distance to MRF \>1 mm) in patients who wish to pursue organ preservation
•\- No signs of distant metastases
•\- patients must be willing to undergo proctoscopy and biopsies prior to start of treatment and during treatment at defined timepoints
•\- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•\- Life expectancy \> 6 months

•\- 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 (e.g., expected 5\-year overall survival \> 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent).
•\- 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
•\- 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, including anti\-PD\-1 and anti\-PD\-L1, with MEK inhibitor or VEGF/VEGFR inhibitors
•\- History of clinically significant cardiac or pulmonary dysfunction
•\- Autoimmune conditions
•\- Infectious diseases