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出境医 / 临床实验 / Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN) (TARZAN)

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

Study Description
Brief Summary:
In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Atezolizumab Drug: Bevacizumab Phase 2

Detailed Description:
38 patients with resectable rectal cancer will be enrolled. All patients will be treated with radiotherapy followed by bevacizumab and atezolizumab.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single group, open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : August 30, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: bevacizumab and atezolizumab
1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy
 Drug: Atezolizumab
3 cycles of atezolizumab 840 mg
Other Name: MPDL3280A

Drug: Bevacizumab
3 cycles of bevacizumab 5mg/kg
Other Name: HCA 185 ,Avastin
Outcome Measures
Primary Outcome Measures :
  1. clinical complete and near-complete response rate [ Time Frame: 12 weeks post-radiotherapy ]
    response rate will be assessed by MRI and endoscopy


Secondary Outcome Measures :
  1. incidence of adverse events following treatment (safety) [ Time Frame: untill 100 days after last patient last study drug ]
    adverse events will be assessed (according tot CTC-AE v5) during treatment

  2. local recurrence rate at 1 year follow-up [ Time Frame: 1 year post-radiotherapy ]
    recurrence will be assessed by MRI and CT scans


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Marieke van de Belt +3120512 ext 1926 m.vd.belt@nki.nl

Locations
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Netherlands
Marieke van de Belt Recruiting
Amsterdam, Noord-Holland, Netherlands, 1066CX
Contact: Marieke van de Belt    +3120512 ext 1926    m.vd.belt@nki.nl   
Sponsors and Collaborators
The Netherlands Cancer Institute
Hoffmann-La Roche
Investigators
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Principal Investigator: Myriam Chalabi, MD Antoni van Leeuwenhoek
Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date April 20, 2021
Actual Study Start Date  ICMJE October 22, 2019
Estimated Primary Completion Date August 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019) 		clinical complete and near-complete response rate [ Time Frame: 12 weeks post-radiotherapy ]
response rate will be assessed by MRI and endoscopy
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019) 		clinical complete and near-complete response rate [ Time Frame: 12 weeks post-radiotherapy ]
response rate will be assessed by visible lesions at procotscopy and visible tumor at MRI
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
  • incidence of adverse events following treatment (safety) [ Time Frame: untill 100 days after last patient last study drug ]
    adverse events will be assessed (according tot CTC-AE v5) during treatment
  • local recurrence rate at 1 year follow-up [ Time Frame: 1 year post-radiotherapy ]
    recurrence will be assessed by MRI and CT scans
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019) 		incidence of adverse events following treatment (safety) [ Time Frame: untill 100 days after last patient las study drug ]
adverse events will be assessed (according tot CTC-AE v5) during treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)
Official Title  ICMJE Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)
Brief Summary In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab
Detailed Description 38 patients with resectable rectal cancer will be enrolled. All patients will be treated with radiotherapy followed by bevacizumab and atezolizumab.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
single group, open label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Cancer
Intervention  ICMJE
  • Drug: Atezolizumab
    3 cycles of atezolizumab 840 mg
    Other Name: MPDL3280A
  • Drug: Bevacizumab
    3 cycles of bevacizumab 5mg/kg
    Other Name: HCA 185 ,Avastin
Study Arms  ICMJE Experimental: bevacizumab and atezolizumab
1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy
Interventions:
  • Drug: Atezolizumab
  • Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2019) 		38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2024
Estimated Primary Completion Date August 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marieke van de Belt +3120512 ext 1926 m.vd.belt@nki.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04017455
Other Study ID Numbers  ICMJE N18TRZ
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Netherlands Cancer Institute
Study Sponsor  ICMJE The Netherlands Cancer Institute
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Principal Investigator: Myriam Chalabi, MD Antoni van Leeuwenhoek
PRS Account The Netherlands Cancer Institute
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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