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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Capecitabine monotherapy
Sponsored by
The First Affiliated Hospital of Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Capecitabine monotherapy group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Disease-free/Relapse-free survival
The time interval from randomization to local recurrence/distant metastasis, death, or end of follow-up whichever occurs first.

Secondary Outcome Measures

Overall survival
The time interval from randomization to death from any cause or end of follow-up whichever occurs first.
Incidence of Treatment-Emergent Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events
Incidence of Treatment-Emergent/Drug-Associated Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events
Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30
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.

Full Information

First Posted
January 18, 2019
Last Updated
April 17, 2020
Sponsor
The First Affiliated Hospital of Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03817268
Brief Title
Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection
Acronym
CAPOGA
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
January 16, 2026 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Anhui Medical University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
768 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine monotherapy group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Capecitabine monotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free/Relapse-free survival
Description
The time interval from randomization to local recurrence/distant metastasis, death, or end of follow-up whichever occurs first.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
The time interval from randomization to death from any cause or end of follow-up whichever occurs first.
Time Frame
5 years
Title
Incidence of Treatment-Emergent Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events
Description
Incidence of Treatment-Emergent/Drug-Associated Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events
Time Frame
2 years
Title
Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A-Man Xu, MD
Phone
+49-13705695470
Email
amanxu@163.com
Email
amanxu@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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