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

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Oxaliplatin; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT03961867

SAHMO203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

DS

Experimental group

Description:

D2 resection -- S1 \* 1 cycle + DS \* 6 cycles + S1 \* 9 cycles

Treatment:

Drug: Docetaxel

SOX

Active Comparator group

Description:

D2 resection -- SOX \* 8 cycles + S1 \* 8 cycles

Treatment:

Drug: Oxaliplatin