Phase III Study to Compare Perioperative Chemotherapy of Oxaliplatin Combined With S-1(SOX) Versus SOX or Oxaliplatin With Capecitabine (XELOX) as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection

Last updated: September 14, 2019
Sponsor: Peking University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Carcinoma

Adenocarcinoma

Gastric Cancer

Treatment

N/A

Clinical Study ID

NCT01534546
CGOG1003-RESOLVE
CGOG 1003
  • Ages > 18
  • All Genders

Study Summary

Peri-operative treatment of locally advanced gastric cancer (LAGC) has always been argued by eastern and western scholars. For patients with clinical stage of cT4b/N+M0, or cT4aN+M0, the prognosis is rather poor, and the primary lesions might not be resectable at the time of diagnosis. MAGIC study has showed that pre-and post-operative chemotherapy with 3 cycles of ECF has increased 13% on 5yOS compared with surgery alone; However, eastern studies such as ACTS GC or CLASSIC showed that TS-1 monotherapy or XELOX (oxaliplatin/capecitabine) combination given as adjuvant chemotherapy for stage II or III patients after D2 surgery could achieve the significant survival benefit. So whether perioperative or post operative therapy is more beneficial for LAGC patients lacks of data supported by prospective study.

So in this prospective randomized phase III study, the investigators aim to compare the survival benefit as well as the safety for SOX (oxaliplatin/TS-1) as perioperative therapy versus SOX or XELOX as postoperative therapy after D2 dissection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • sign written informed consent form

  • age ≥ 18 years

  • pathologically confirmed gastric or GEJ adenocarcinoma

  • disease at clinical stage of resectable or potentially resectable LAGC(T4a-b/N+M0)

  • No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immunetherapy or target therapy

  • Adequate organ function as defined below: Hematologic ANC ≥ 1.5109/l Hemoglobin ≥ 9 g/dl Platelets ≥ 100109/l Hepatic Albumin ≥ 30g/l Serum bilirubin ≤ 1.5×ULN AST and ALT ≤ 2.5×ULN ALP ≤ 2.5×ULN TBIL ≤ 1.5×ULN RenalSerum Creatinine < 1.5 ULN

  • KPS ≥ 70

  • Adequate lung and heart function

  • Negative serum or urine pregnant test within 7 days prior to randomization forchild-bearing age women

  • Sexually active males or females willing to practice contraception during the studyuntil 30 days after end of study.

Exclusion

Exclusion Criteria:

  • Refuse to provide blood/tissue sample;

  • With distant metastasis;

  • Sexually active males or females refuse to practice contraception during the studyuntil 30 days after end of study.

  • Known hypersensitivity reaction or metabolic disorder to fluorpyrimidines oroxaliplatin;

  • ≥ grade 1 peripheral neuropathy;

  • History of organ transplantation(including autologous bone marrow transplantation andPeripheral stem cell transplantation);

  • Prior long term steroid therapy (excluding short term steroid treatment which iscompleted prior to > 2 weeks of study enrollment);

  • Patients with central nervous system(CNS) disorder or peripheral nervous systemdisorder or psychiatric disease;

  • Concurrent severe infection;

  • unable to swallow; (complete or incomplete)gastrointestinal obstruction;gastrointestinal bleeding; gastrointestinal perforation;

  • Concurrent disease or condition that would make the subject inappropriate for studyparticipation or any serious medical disorder that would interfere with the subject'ssafety (including current active hepatic, biliary, renal, respiratory disease,uncontrolled diabetes hypertension et al);

  • History of other malignancy. However, subjects who have been disease-free for 5 years,or subjects with a history of completely resected non-melanoma skin cancer orsuccessfully treated in situ carcinoma, are eligible;

  • Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias andhypertension, or congestive heart failure, or cardiac infarction within 6 months priorto study enrollment, or cardiac insufficiency;

  • Person with no capacity (legally) or inappropriate to continue study treatment forethics/medical reasons;

Study Design

Total Participants: 1094
Study Start date:
March 01, 2012
Estimated Completion Date:
September 30, 2021

Study Description

detailed discription of protocol updated on Feb 2013; detailed discription of protocol updated on Apr 2013; detailed discription of protocol updated on Oct 2013;

Connect with a study center

  • Lin Shen

    Beijing,
    China

    Site Not Available

  • Peking Unicersity Cancer Hospital

    Beijing,
    China

    Site Not Available

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