To Observe the Efficacy and Safety by Comparing Chemotherapy(Docetaxel, Oxaliplatin Plus S1 ) Followed With Radical Resection Versus Chemotherapy Alone in Advanced Gastric Cancer With Single Non-curable Factor.

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03001726
Collaborator
(none)
228
1
83
2.7

Study Details

Study Description

Brief Summary

Investigators assessed the effectiveness of conversional gastrectomy compared with chemotherapy alone following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Palliative chemotherapy is still the standard of care for incurable advanced gastric cancer. Several retrospective, single institutional studies have shown that the addition of gastrectomy to chemotherapy might improve patient survival among patients with metastatic gastric cancer with a single non-curable factor. However, REGATTA trial, a phase 3, randomized controlled trial, concluded an opposite conclusion that gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor. Interestingly, five patients initially assigned to chemotherapy alone in the study had got survival benefit form gastrectomy with curative intent because of complete disappear of all non-curable factors during chemotherapy. This finding raised the question as to conversional radical surgery following upfront chemotherapy could be a possible treatment option. We assessed the effectiveness of conversional radical surgery following docetaxel, oxalipaltin and S1 therapy for advanced gastric cancer with a single non-curable factor.

Study Design

Study Type:
Observational
Anticipated Enrollment :
228 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Gastrectomy Plus Chemotherapy Versus Chemotherapy Alone for Advanced Gastric Cancer With a Single Non-curable Factor
Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Gastrectomy plus chemotherapy

In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.

Procedure: Gastrectomy
In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.

Drug: oxaliplatin
oxaliplatin 100 mg/m2
Other Names:
  • Eloxatin
  • Drug: S1
    S1 40mg/m2
    Other Names:
  • tegafur
  • Drug: Docetaxel
    docetaxel 40 mg/m2
    Other Names:
  • Taxotere
  • chemotherapy alone

    Patients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: <1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and >1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle.

    Drug: oxaliplatin
    oxaliplatin 100 mg/m2
    Other Names:
  • Eloxatin
  • Drug: S1
    S1 40mg/m2
    Other Names:
  • tegafur
  • Drug: Docetaxel
    docetaxel 40 mg/m2
    Other Names:
  • Taxotere
  • Outcome Measures

    Primary Outcome Measures

    1. overall survival [through study completion, an average of 2 year]

    Secondary Outcome Measures

    1. progression-free survival [through study completion, an average of 1 year]

    Other Outcome Measures

    1. response rate [through study completion, an average of 24 weeks]

    2. adverse events [through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinical diagnosis of gastric cancer with a single non-curable factor

    • A single non-curable factor was defined as hepatic metastasis (H1; two to four lesions of maximum diameter ≤5 cm and minimum diameter ≥1 cm); peritoneal metastasis (P1) in the diaphragm or peritoneum caudal to the transverse colon without massive ascites or intestinal obstruction; positive cytology (CY1) when the cancer cells were found in the peritoneal washing; para-aortic lymph node (PAN) metastasis above the coeliac axis or below the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter ≥1 cm), or both; or ovary implant metastasis for one site or two.

    Exclusion Criteria:
    • Patients who can have radical resection.

    • Patietns who have more than one metastasis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan hospital Shanghai Shanghai China 200000

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital

    Investigators

    • Principal Investigator: Tianshu Liu, Physician, Zhongshan Hopital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tianshu Liu, Chairman for the department of oncology, Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT03001726
    Other Study ID Numbers:
    • NEO-REGATTA
    First Posted:
    Dec 23, 2016
    Last Update Posted:
    May 6, 2022
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2022