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

P

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)

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

Trial contacts and locations

15

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Central trial contact

Biao Fan, MD, Ph.D; Jiafu Ji, MD

Data sourced from clinicaltrials.gov

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