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Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03961867
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Ping Lan, Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary:

S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer.

Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer.

This trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.


Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Docetaxel Drug: Oxaliplatin Phase 3

Detailed Description:

In this study, patients with gastric or EGJ adenocarcinoma who received D2 dissection and staged II or III, aged from 18 to 75 years and with ECOG PS ≤2 and adequate organ function, are stratified randomized according to pstage and location of primary lesion.

Group DS:

S-1 is orally administer by BSA (<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.

Docetaxel 40mg/m2/3w from the second to the seventh cycles.

Group SOX:

S-1 is orally administer by BSA (<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.

Oxaliplatin 100mg/m2/3w from the second to the seventh cycles.

The primary end point is disease-free survival(DFS). The overall survival (OS), safty and quality of life are secondary end points.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 622 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: S-1 Plus Docetaxel(DS) Versus S-1 Plus Oxaliplatin(SOX) as Postoperative Therapy for Stage II / III Gastric Cancer, a Randomized Controlled Trial
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: DS
D2 resection -- S1 * 1 cycle + DS * 6 cycles + S1 * 9 cycles
Drug: Docetaxel

S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.

Docetaxel 40mg/m2/3w from the second to the seventh cycles.

Other Name: S-1

Active Comparator: SOX
D2 resection -- S1 * 1 cycle + SOX * 6 cycles + S1 * 9 cycles
Drug: Oxaliplatin

S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.

Oxaliplatin 100mg/m2/3w from the second to the seventh cycles.

Other Name: S-1




Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 3 year ]
    The interval from randomization to local recurrence, distant metastasis, death or the last follow-up


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 year ]
    The interval from randomization to death or the last follow-up

  2. Treatment related Adverse Events [ Time Frame: 1 year ]
    According to CTC version 3



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consensus of patients
  • be able to receive oral administration
  • from 18 to 75 years old
  • be proven to be primary adenocarcinoma of stomach and staged II or III by pathological evidences
  • without other chemotherapy and/or radiation against to the disease
  • normal function of other organs including heart,liver ,kidney and so on
  • Eastern Cooperative Oncology Group performance status:0~2

Exclusion Criteria:

  • history of other malignancy
  • allergic reaction to S-1 or oxaliplatin of docetaxel
  • be enrolling in other clinical trials
  • abnormal GI tract function
  • dysfunction of other organs
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961867


Contacts
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Contact: Shanshan Li, MD 86-20-38285497 lishsh89@163.com
Contact: Jian Xiao, MD 86-20-38285497 xiaoj26@mail.sysu.edu.cn

Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
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Principal Investigator: Ping Lan Sixth Affiliated Hospital, Sun Yat-sen University

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Responsible Party: Ping Lan, Professor, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03961867     History of Changes
Other Study ID Numbers: SAHMO203
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Oxaliplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action