Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2021-09-01

Brief Summary

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The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.

Detailed Description

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The study is a multi-central, controlled, randomized Phase III trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A: postoperative Oxaliplatin plus S-1

Patients in arm A will receive standard distal gastrectomy with D2 lymphadenectomy first, and 8 cycles of adjuvant Oxaliplatin plus S-1 (SOX) later.

Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3W S-1: 40\~60mg bid, po, d1\~14, q3W (6 months)

Group Type EXPERIMENTAL

Oxaliplatin plus S-1

Intervention Type DRUG

8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1

B: postoperative S-1 only

Patients in arm B will receive standard distal gastrectomy with D2 lymphadenectomy first, and 16 cycles of adjuvant S-1 later.

S-1: 40\~60mg bid, po, d1\~14, q3W (12 months)

Group Type ACTIVE_COMPARATOR

S-1 only

Intervention Type DRUG

16 cycles of adjuvant chemotherapy with S-1 only

Interventions

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Oxaliplatin plus S-1

8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1

Intervention Type DRUG

S-1 only

16 cycles of adjuvant chemotherapy with S-1 only

Intervention Type DRUG

Other Intervention Names

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SOX S-1

Eligibility Criteria

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Inclusion Criteria

* sign written informed consent form
* age ≥ 18 years, ≤69 years
* ECOG status: 0\~2
* pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version)
* negative peritoneal cytology
* underwent curative distal gastrectomy with D2 lymph node dissection
* no prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
* adequate organ function as defined below: Hematologic ANC ≥ 2\*109/L, Platelets ≥ 100\*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.

Exclusion Criteria

* be enrolled in other clinical trials
* underwent prior antitumor treatment
* allergic reaction to S-1 or oxaliplatin
* abnormal GI tract function
* 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

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiafu Ji, MD

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Locations

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