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Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection (CAPOGA)

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: NCT03817268
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
A-Man Xu, The First Affiliated Hospital of Anhui Medical University

Brief Summary:
Gastric cancer (GC) is one of the most common and lethal malignancies in Asia. For early (stage T1) GC, it has been found by analyzing surgical specimens that ~5% of cancers have lymph node metastasis. For patients with stage T2-3N0M0 GCs, there is a considerable probability of micro-metastasis. While the US National Comprehensive Cancer Network (NCCN), the Japanese Gastric Cancer Association (JGCA), and the European Society for Medical Oncology (ESMO) guidelines recommend adjuvant therapy for most patients with resected >T1N0 GCs, the recommendations vary regarding postsurgical treatment for patients with stage T1N+M0 or T2-3N0M0 disease. The JGCA guidelines do not recommend postsurgical chemotherapy for this patient population, while the ESMO support the adjuvant treatment. The NCCN has not offered a definitive recommendation on this issue. Through careful literature search, there is not yet randomized report on whether postsurgical chemotherapy benefits survival for patients with resected T1N+M0 or T2-3N0M0 GC. The first-line chemotherapy regimen for GC is fluorouracil plus platinum. Among fluorouracil, platinum is especially favored due to its less frequent and less severe adverse effects. This large multicenter phase III randomized controlled trial is led by Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, and carried out in multiple Chinese centers, aiming to compare the safety and efficacy of capecitabine monotherapy versus no therapy in the adjuvant setting for patients with stage T1N+M0 or T2-3N0M0 GC undergoing R0 Resection.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Capecitabine monotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 768 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection (CAPOGA): A Large Multicenter Phase III Randomized Controlled Trial
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : January 16, 2026
Estimated Study Completion Date : January 30, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Capecitabine monotherapy group Drug: Capecitabine monotherapy
Capecitabine is administered within 6 weeks after resection and after adequate recovery. To reduce the side effects and improve patient compliance, the administered dose is half of the recommendation: 625 mg/m2, bis in die (BID) (1250 mg/m2 per day). A 2-week therapy is followed by a 1-week pause, and a cycle includes 3 weeks. A total of 8 cycles is planned for each patient.

No Intervention: Control group



Primary Outcome Measures :
  1. Disease-free/Relapse-free survival [ Time Frame: 5 years ]
    The time interval from randomization to local recurrence/distant metastasis, death, or end of follow-up whichever occurs first.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    The time interval from randomization to death from any cause or end of follow-up whichever occurs first.

  2. Incidence of Treatment-Emergent Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events [ Time Frame: 2 years ]
    Incidence of Treatment-Emergent/Drug-Associated Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events

  3. Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 [ Time Frame: 5 years ]
    Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30. Except for the last 2 questions, for the first 28 questions higher values represent a worse outcome.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Microscopically-confirmed gastric adenocarcinoma (cardia cancer/adenocarcinoma of the esophagogastric junction);
  • Cancer stage pT1N+M0 or pT2-3N0M0;
  • Radical R0 resection;
  • Retrieved lymph node number ≥15;
  • Without hepatic, peritoneal, or other distant metastasis;
  • Aged 18-70 years;
  • No other cancer-directed therapy except primary cancer resection;
  • Good tissue and organ function: white blood cell count ≥4000/mm3; neutrophil count ≥1500/mm3; platelet count ≥100000/mm3; total bilirubin ≤25.7 μmol/L or within 1.5 times the upper threshold; aspartate transaminase (AST) and alanine transaminase (ALT) within 2.5 times the upper threshold; creatinine within 1.25 times the upper threshold; creatinine clearance rate >60 mL/min;
  • No serious cardiovascular or cerebrovascular disease;
  • No concomitant or previous malignancies;
  • Enrolled within 6 weeks after resection;
  • Eastern Cooperative Oncology Group (ECOG) score ≤2;
  • Clavien-Dindo morbidity score 0-2;
  • Patient informed consent.

Exclusion Criteria:

  • The need to take phenytoin or coumarin anti-coagulates;
  • Allergic to capecitabine or fluorouracil;
  • Known DPD activity deficiency (DPYD gene mutation);
  • Pregnant or breeding women;
  • All others contradictory to the items listed in the Inclusion Criteria.

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): NCT03817268


Locations
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China, Anhui
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China, 230022
Contact: A-Man Xu, MD    +49-13705695470    amanxu@163.com   
Contact       amanxu@163.com   
Sponsors and Collaborators
The First Affiliated Hospital of Anhui Medical University

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Responsible Party: A-Man Xu, Professor, Chief Surgeon, Department Head, The First Affiliated Hospital of Anhui Medical University
ClinicalTrials.gov Identifier: NCT03817268    
Other Study ID Numbers: CAPOGA-01
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents