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Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Resectable Gastric and GE-junction Cancer (PANDA) (PANDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03448835
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : April 20, 2021
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Brief Summary:

In this explorative study, patients with resectabel cancer of the stomach or stomach-oesophagealjunction cancer will receive neoadjuvant treatment.

The treatment will be 1 cyle atzolizumab monotherapy, followed by 4 cycle of atezolizumab and capecitabine, oxaliplatin and docetaxel.


Condition or disease Intervention/treatment Phase
Stomach Cancer Gastro Esophageal Junction Cancer Drug: Atezolizumab Drug: Capecitabine Drug: Oxaliplatin Drug: Docetaxel Phase 2

Detailed Description:

In this single-centre, open-label, monocenter study, the investigators will enroll 20 patients with resectable cancer of the stomach of GEJunction.

All patients will be treated with 1 cycle of atezolizumab monotherapy, followed by 4 cycles of combinationtherapy of atezolizumab, capecitabine, oxaliplatin and docetaxel, followed by surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Non-metastatic, Resectable Gastric and GE-junction Cancer: The PANDA Trial
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: atezolizumab and chemotherapy
1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel
Drug: Atezolizumab
atezolizumab 1200 mg 5 cycles
Other Name: MPDL3280A

Drug: Capecitabine
capecitabine 850 mg /m2 4 cycles
Other Name: L01BC06

Drug: Oxaliplatin
oxaliplatin 100 mg/m2 4 cycles
Other Name: L01XA03

Drug: Docetaxel
docetaxel 50 mg/m2 4 cycles
Other Name: L01CD02




Primary Outcome Measures :
  1. Incidence of adverse events following treatment (safety) [ Time Frame: until 100 days after last patient last study drug treatment ]
    Adverse events will be assessed (according to CTC-AE v4.0) during treatment


Secondary Outcome Measures :
  1. pathological tumor regression grade [ Time Frame: Within 6 months after last patient inclusion ]
    determined using the Mandard tumor regression grading system



Information from the National Library of Medicine

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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 and older
  • primary resectable, histologically confirmed gastric or GEJ adenocarcinoma

Exclusion Criteria:

  • no signs of distant metastases
  • no active or history of autoimmune disease or immune deficiency
  • no significant cardiovascular disease
  • no major surgical procedure within 4 weeks prior to initiation of study treatment
  • no current treatment with anti-viral therapy or HBV
  • no pregnancy or breastfeeding
  • no history of malignancy within 3 years prior to screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448835


Contacts
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Contact: Marieke van de Belt +3120512 ext 9111 m.vd.belt@nki.nl

Locations
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Netherlands
Marieke van de Belt Recruiting
Amsterdam, Netherlands, 1066CX
Contact: Marieke van de Belt    +3120512 ext 1926    m.vd.belt@nki.nl   
Catharina ziekenhuis Recruiting
Eindhoven, Netherlands
Contact: G. Nieuwenhuijzen         
Sponsors and Collaborators
The Netherlands Cancer Institute
Hoffmann-La Roche
Investigators
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Principal Investigator: Myriam Chalabi, MD Antoni van Leeuwenhoek
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03448835    
Other Study ID Numbers: N17PND
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
short term immunotherapy
surgical resection
atezolizumab
capecitabine
oxaliplatin
docetaxel
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Capecitabine
Oxaliplatin
Atezolizumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites