Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma

Phase 3

Recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: Docetaxel; Drug: Oxaliplatin

• Registration Number: NCT03961867
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer.

Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer.

This trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.

Detailed Description

In this study, patients with gastric or EGJ adenocarcinoma who received D2 dissection and staged II or III, aged from 18 to 75 years and with ECOG PS ≤2 and adequate organ function, are stratified randomized according to pstage and location of primary lesion.

Group DS:

S-1 is orally administer by BSA (\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \>1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.

Docetaxel 40mg/m2/3w from the second to the seventh cycles.

Group SOX:

S-1 is orally administer by BSA (\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \>1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.

Oxaliplatin 130mg/m2/3w from the first to the eight cycles.

The primary end point is disease-free survival(DFS). The overall survival (OS), safty and quality of life are secondary end points.

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Study Start: 2020-09-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-06-01
• Primary Completion: 2022-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

• informed consensus of patients
• be able to receive oral administration
• from 18 to 75 years old
• be proven to be primary adenocarcinoma of stomach and staged II or III by pathological evidences
• without other chemotherapy and/or radiation against to the disease
• normal function of other organs including heart,liver ,kidney and so on
• Eastern Cooperative Oncology Group performance status:0~2

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Exclusion Criteria

• history of other malignancy
• allergic reaction to S-1 or oxaliplatin of docetaxel
• be enrolling in other clinical trials
• abnormal GI tract function
• dysfunction of other organs
• female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy
• other situation to be judged not adaptive to the study by investigators

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DS	Docetaxel	D2 resection -- S1 \* 1 cycle + DS \* 6 cycles + S1 \* 9 cycles
SOX	Oxaliplatin	D2 resection -- SOX \* 8 cycles + S1 \* 8 cycles

Primary Outcome Measures

Name	Time	Method
disease-free survival	3 year	The interval from randomization to local recurrence, distant metastasis, death or the last follow-up

Secondary Outcome Measures

Name	Time	Method
overall survival	5 year	The interval from randomization to death or the last follow-up
Treatment related Adverse Events	1 year	According to CTC version 5

Trial Locations

Locations (1)

Sixth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, China