Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer

January 16, 2026 updated by: Jun Zhang, Ruijin Hospital

Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer After D2 Gastrectomy (DRAGON-Adjuvant): a Multicenter, Open-label, Phase 3, Randomized, Non-inferiority Study

This is a multicenter, open-label, phase 3, randomized, non-inferiority study aimed to investigate the effect on disease-free survival of adjuvant chemotherapy with oxaliplatin plus S-1 compared with adjuvant chemotherapy with docetaxel plus S-1 after D2 gastrectomy in patients with stage III gastric cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In gastric cancer, adjuvant chemotherapy that can reduce the risk of recurrence and improve patient survival has been a standard of care for gastric cancer patients with pathological stage II-III after D2 gastrectomy and R0 resection. Currently, oxaliplatin plus S-1 (SOX) or docetaxel plus S-1 (DS) have been recommended as adjuvant therapy for stage III gastric cancer patients, based on the results of RESOLVE trial and JACCRO GC-07 trial, respectively. However, due to the different study design and patient enrollment, the efficacy of these two regimens can hardly be compared directly. The safety profiles and treatment period of the two regimens can be factors to guide regimen selection. For SOX regimen, oxaliplatin-related peripheral neuropathy and allergy are clinical concerned issues. Although frequency of similar toxicities of docetaxel is lower, S-1 should be administrated for 12 months after surgery in the DS regimen. Prolonged treatment period also increases the risk of treatment-related toxicities and impairs patients' adherence. There is necessary to compare these two regimens directly. In this study, gastric cancer patients who undergo D2 gastrectomy and achieve R0 resection with pathological stage III (IIIA, IIIB, IIIC) will be randomized and treated with SOX or DS regimen. In SOX group, eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; >1.5m2 60mg twice a day, days 1 to 14 of each cycle). In DS group, S-1 dose is also determined by body surface area. Patients are treated with S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year. Patients will be followed up for 5 years after surgery.

Study Type

Interventional

Enrollment (Estimated)

387

Phase

  • Phase 3

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 Locations

  • China
      • Shanghai, China
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital
        • Contact:
      • Shanghai, China
        • Not yet recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
      • Shanghai, China
        • Not yet recruiting
        • Renji Hospital
        • Contact:
    • Guandong
      • Shaoguan, Guandong, China
        • Not yet recruiting
        • Yuebei People's Hospital
        • 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

Description

Inclusion Criteria:

  1. age 18 to 80 years old, male and female
  2. histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
  3. patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy
  4. American Joint Committee on Cancer stage IIIA (T2N3a, T3N2, T4aN1, T4aN2, T4bN0), IIIB (T1N3b, T2N3b, T3N3a, T4aN3a, T4bN1, T4bN2), IIIC (T3N3b, T4aN3b, T4bN3a, T4bN3b), and has Lauren classification
  5. with no evidence of metastatic disease
  6. ECOG 0 to 1
  7. Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
  8. Woman of childbearing age should contracept for at least one month before screening and commit to using contraception throughout the entire study period and for the specified time after the study ends.
  9. Signed informed consent and willing to follow the study protocol

Exclusion Criteria:

  1. other primary malignancies, except for cured skin tumors or cervical carcinoma in situ
  2. severe complications that may lead to an expected survival time less than 5 years
  3. uncontrollable comorbidities, such as infectious disease, chronic diseases like hypertension, diabetes, heart diseases.
  4. allergic to study medication
  5. bowel obstruction or other conditions affecting oral administration
  6. organ functions that cannot tolerate study treatment
  7. other conditions that patients are unsuitable for this study assessed by the investigators

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxaliplatin plus S-1
Patients will be treated with oxaliplatin plus S-1 as adjuvant therapy
Drug: Oxaliplatin plus S-1
SOX group: eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; >1.5m2 60mg twice a day, days 1 to 14 of each cycle).
Active Comparator: Docetaxel plus S-1
Patients will be treated with docetaxel plus S-1 as adjuvant therapy
Drug: Docetaxel plus S-1
DS group: S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease-free survival rate
Time Frame: From randomization to 3 years after randomization
Defined as the proportion of patients who remain free from recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause at 3 years after randomization.
From randomization to 3 years after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year overall survival rate
Time Frame: From randomization to 5 years after randomization
Defined as the proportion of patients who remain survival at 5 years after randomization.
From randomization to 5 years after randomization
Safety profiles
Time Frame: through treatment completion, an average of 6 months
Adverse events during treatment
through treatment completion, an average of 6 months
Recurrence sites
Time Frame: From randomization to 3 years after randomization
Organs involved in tumor metastasis and recurrence
From randomization to 3 years after randomization

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

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)

December 15, 2025

Primary Completion (Estimated)

October 30, 2028

Study Completion (Estimated)

October 31, 2030

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRAGON-Adjuvant/2025-No.675

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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