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

NCT ID: NCT03961867

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2025-09-30

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DS

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

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.

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

SOX

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

Group Type: ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type: DRUG

S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.

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

Interventions

Docetaxel

S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.

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

Intervention Type: DRUG

Oxaliplatin

S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.

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

Intervention Type: DRUG

Other Intervention Names

S-1; S-1

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jian Xiao

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Xiao, MD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shanshan Li, MD

Role: CONTACT

lishsh89@163.com

86-20-38285497

Facility Contacts

Jian Xiao, MD

Role: primary

xiao_jian@139.com

Other Identifiers

SAHMO203

Identifier Type: -

Identifier Source: org_study_id