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出境医 / 临床实验 / Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma

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

Study Description
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 130mg/m2/3w from the first to the eight cycles.

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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 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
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2025
Arms and Interventions
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 -- SOX * 8 cycles + S1 * 8 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 130mg/m2/3w from the first to the eight cycles.

Other Name: S-1
Outcome Measures
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 5


Eligibility Criteria
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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
Contacts and Locations

Contacts
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Contact: Shanshan Li, MD 86-20-38285497 lishsh89@163.com

Locations
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China
Sixth Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, China, 510655
Contact: Jian Xiao, MD       xiao_jian@139.com   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
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Principal Investigator: Jian Xiao, MD Sixth Affiliated Hospital, Sun Yat-sen University
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date June 1, 2021
Actual Study Start Date  ICMJE September 15, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		disease-free survival [ Time Frame: 3 year ]
The interval from randomization to local recurrence, distant metastasis, death or the last follow-up
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		disease-free survival [ Time Frame: 3 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2021)
  • overall survival [ Time Frame: 5 year ]
    The interval from randomization to death or the last follow-up
  • Treatment related Adverse Events [ Time Frame: 1 year ]
    According to CTC version 5
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • overall survival [ Time Frame: 5 year ]
  • Number of Participants with Adverse Events [ Time Frame: 5 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma
Official Title  ICMJE S-1 Plus Docetaxel(DS) Versus S-1 Plus Oxaliplatin(SOX) as Postoperative Therapy for Stage II / III Gastric Cancer, a Randomized Controlled Trial
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.
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 130mg/m2/3w from the first to the eight cycles.

The primary end point is disease-free survival(DFS). The overall survival (OS), safty and quality of life are secondary end points.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • 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
  • 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 130mg/m2/3w from the first to the eight cycles.

    Other Name: S-1
Study Arms  ICMJE
  • Experimental: DS
    D2 resection -- S1 * 1 cycle + DS * 6 cycles + S1 * 9 cycles
    Intervention: Drug: Docetaxel
  • Active Comparator: SOX
    D2 resection -- SOX * 8 cycles + S1 * 8 cycles
    Intervention: Drug: Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2021) 		440
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		622
Estimated Study Completion Date  ICMJE September 2025
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shanshan Li, MD 86-20-38285497 lishsh89@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961867
Other Study ID Numbers  ICMJE SAHMO203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University
Study Sponsor  ICMJE Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jian Xiao, MD Sixth Affiliated Hospital, Sun Yat-sen University
PRS Account Sixth Affiliated Hospital, Sun Yat-sen University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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