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NCT04017455 Clinical Trial

Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)

Rectal Cancer Clinical Trial

— TARZAN  

Official title:
Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04017455
Other study ID # N18TRZ
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 22, 2019
Est. completion date August 30, 2024

Study information
Verified date April 2021
Source The Netherlands Cancer Institute
Contact Marieke van de Belt
Phone +3120512
Email m.vd.belt@nki.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab

Description:

38 patients with resectable rectal cancer will be enrolled. All patients will be treated with radiotherapy followed by bevacizumab and atezolizumab.

Recruitment information / eligibility
Status Recruiting
Enrollment 38
Est. completion date August 30, 2024
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - signed informed consent - patients age 18 years and older - histologically confirmed adenocarcinoma of the rectum - intermediate risk rectal cancer or low risk distal rectal cancer Exclusion Criteria: - evidence of metastatic disease - prior radiation therapy for disease under study - prior treatment with CD137 agonists or immune checkpoint blockade therapies - current or recent use of acetylsalicylic acid - history of clinically significant cardiac or pulmonary dysfunction pregnancy or breastfeeding - significant auto-immune disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atezolizumab
3 cycles of atezolizumab 840 mg
• Bevacizumab
3 cycles of bevacizumab 5mg/kg

Locations
Country Name City State
Netherlands Marieke van de Belt Amsterdam Noord-Holland

Sponsors (2)
Lead Sponsor Collaborator
The Netherlands Cancer Institute Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary clinical complete and near-complete response rate response rate will be assessed by MRI and endoscopy 12 weeks post-radiotherapy
Secondary incidence of adverse events following treatment (safety) adverse events will be assessed (according tot CTC-AE v5) during treatment untill 100 days after last patient last study drug
Secondary local recurrence rate at 1 year follow-up recurrence will be assessed by MRI and CT scans 1 year post-radiotherapy
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