Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage... | NCT03961867

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

NCT03961867

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Status

Unknown status

Last Update Posted

Jun 1, 2021Actual

Enrollment

440Estimated

Phase

Phase 3

Conditions

Gastric Cancer

Interventions

Docetaxel
Oxaliplatin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2020Actual

Primary Completion Date

Sep 2022Estimated

Completion Date

Sep 2025Estimated

First Submitted Date

May 22, 2019

First Submission Date that Met QC Criteria

May 22, 2019

First Posted Date

May 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2021

Last Update Posted Date

Jun 1, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jian Xiao, Associate Professor, Sixth Affiliated Hospital, Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

Sixth Affiliated Hospital, Sun Yat-sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

440Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DS	Experimental	D2 resection -- S1 * 1 cycle + DS * 6 cycles + S1 * 9 cycles	Drug: Docetaxel
SOX	Active Comparator	D2 resection -- SOX * 8 cycles + S1 * 8 cycles	Drug: Oxaliplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Docetaxel	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease-free survival	The interval from randomization to local recurrence, distant metastasis, death or the last follow-up	3 year

Secondary Outcomes

Measure	Description	Time Frame
overall survival	The interval from randomization to death or the last follow-up	5 year
Treatment related Adverse Events	According to CTC version 5

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shanshan Li, MD	Contact	86-20-38285497		lishsh89@163.com

Overall Officials

Name	Affiliation	Role
Jian Xiao, MD	Sixth Affiliated Hospital, Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sixth Affiliated Hospital of Sun Yat-sen University	Recruiting	Guangzhou		510655	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077143	Docetaxel
C079198	S 1 (combination)
D000077150	Oxaliplatin

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided