Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric Cancer (RESCUE-GC)

Peking University Cancer Hospital & Institute

Status and phase: Terminated; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: S-1 only; Drug: Oxaliplatin plus S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT02867839

RESCUE-GC-2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

A: postoperative Oxaliplatin plus S-1

Experimental group

Description:

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)

Treatment:

Drug: Oxaliplatin plus S-1

B: postoperative S-1 only

Active Comparator group

Description:

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)

Treatment:

Drug: S-1 only