Duration of Adjuvant Chemotherapy for Gastric Cancer Patients at Pathological N3 Stage

January 11, 2024 updated by: Hongyu Zhang, The First Affiliated Hospital of Zhengzhou University

Duration of Postoperative Adjuvant Chemotherapy (3-4 Months Versus 5-6 Months) for Gastric Cancer Patients at Pathological N3 Stage: a Retrospective Study

The goal of this retrospective study is to compare the efficacy and safety of 3-4 months to 5-6 months of CapOx/SOX adjuvant chemotherapy in pathological N3 gastric cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Due to a heavy metastatic node burden, pathological stage N3 (pN3) gastric cancer (GC) patients have extremely poor prognoses. Except for surgical resection, postoperative adjuvant chemotherapy is the major treatment strategy to improve survival for these patients. Capecitabine plus oxaliplatin (CapOx) and S-1 plus oxaliplatin (SOX) were considered the effective treatment for stage II and III GC after D2 gastrectomy in the CLASSIC and RESOLVE trials. But N3b (positive lymph nodes ≥16) and T1-3N3 patients were omitted in these two trials, respectively. Moreover, only 66.5% of patients finished 6 months of chemotherapy in the CLASSIC trial, and in the RESOLVE trial, 17-19% of patients required dose reductions and about 19% of patients discontinued chemotherapy due to drug-related toxicity for 6 months of chemotherapy. Particularly, cumulative administration of oxaliplatin led to peripheral sensory neurotoxicity, which caused poor quality of life and treatment compliance. Recently, a prospective analysis of six randomized, phase 3 trials with 12834 participants (IDEA trail) for stage III colon cancer, demonstrated that 3 months of CapOx was as effective as 6 months with relatively lower recurrence risk, no significantly different overall survival, and fewer adverse effects. However, there were no relevant studies to explore the optimal duration of chemotherapy for pN3 GC patients.

This study aims to compare the efficacy and safety of 3-4 months to 5-6 months of CapOx/SOX adjuvant chemotherapy in pathological N3 gastric cancer patients.

Study Type

Observational

Enrollment (Estimated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450001
        • Recruiting
        • Department of Gastrointestinal Surgery, the First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Gastric cancer patients who underwent D2 or D2+ procedure and pathologically confirmed stage N3 (AJCC 8th edition)

Description

Inclusion Criteria:

  1. 18-80 years old
  2. Pathological stage N3 GC (≥7 positive lymph nodes) after curative surgery according to the AJCC TNM staging system, 8th edition
  3. Histologically confirmed R0 resection, defined as no macroscopic or microscopic residual tumor
  4. Postoperative chemotherapy with CapOX or SOX doublet regimen, initiating within 6 weeks after curative gastrectomy
  5. No distant metastases or gastric stump cancer
  6. No other malignant tumors

Exclusion Criteria:

  1. Patients who had undergone neoadjuvant chemotherapy or radiotherapy
  2. Patients who received capecitabine or S-1 alone or combined with biological therapy, radiation therapy, or Immunosuppressive therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3-4 months CapOx/SOX

Adjuvant CapOx/SOX 3-4 months after curative surgery:

CapOx: Oxaliplatin: 130 mg/m²/day (day 1) , Capecitabine: 1,000 mg/m², bid (day 1-14), q3W, total 3-4 months (4-6 cycles); SOX: Oxaliplatin: 130 mg/m2/day(day 1) , S-1: 40-60 mg, bid (day 1-14), q3W, total 3-4 months (4-6 cycles)
Drug: Oxaliplatin and capecitabine/ S-1 and capecitabine
Drug: capecitabine: 1000 mg/m² bid, po, d1-14, oxaliplatin: 130mg/m², iv drip for 2h, d1; S-1: BSA<1.25m², 40mg bid, 1.25m²≤BSA≤1.5m², 50mg bid, BSA>1.5m², 60mg bid, po, d1-14, oxaliplatin: 130mg/m², iv drip for 2h, d1
Other Names:
  • Xeloda
5-6 months CapOx/SOX

Adjuvant CapOx/SOX 5-6 months after curative surgery:

CapOx: Oxaliplatin: 130 mg/m²/day (day 1) , Capecitabine: 1,000 mg/m², bid (day 1-14), q3W, total 5-6 months (7-8 cycles); SOX: Oxaliplatin: 130 mg/m2/day(day 1) , S-1: 40-60 mg, bid (day 1-14), q3W, total 5-6 months (7-8 cycles)
Drug: Oxaliplatin and capecitabine/ S-1 and capecitabine
Drug: capecitabine: 1000 mg/m² bid, po, d1-14, oxaliplatin: 130mg/m², iv drip for 2h, d1; S-1: BSA<1.25m², 40mg bid, 1.25m²≤BSA≤1.5m², 50mg bid, BSA>1.5m², 60mg bid, po, d1-14, oxaliplatin: 130mg/m², iv drip for 2h, d1
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 years
The overall survival (OS) will be calculated from the day of surgery to participant's death with any cause
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival
Time Frame: 3 years
The Disease Free Survival (DFS) will be calculated from the day of surgery to participant's recurrence or death with any cause
3 years
Adverse Events
Time Frame: 6 months
Adverse Events of Chemotherapy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Zhengzhou University

Investigators

  • Principal Investigator: Hongyu Zhang, M.D., The First Affiliated hospital of Zhengzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Estimated)

March 28, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

December 22, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-KY-1488

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Research data can be available through contacting the PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Oxaliplatin and capecitabine/ S-1 and capecitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe