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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03961867

Collaborator

(none)

440

Enrollment

Location

Arms

59.5

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

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:

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

Study Type:

Interventional

Anticipated 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 :

Sep 15, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 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 Names: 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 Names: S-1

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 Names:

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 Names:

S-1

Outcome Measures

Primary Outcome Measures

disease-free survival [3 year]
The interval from randomization to local recurrence, distant metastasis, death or the last follow-up

Secondary Outcome Measures

overall survival [5 year]
The interval from randomization to death or the last follow-up
Treatment related Adverse Events [1 year]
According to CTC version 5

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou		China	510655

Sponsors and Collaborators

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

Principal Investigator: Jian Xiao, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT03961867

Other Study ID Numbers:

SAHMO203

First Posted:

May 23, 2019

Last Update Posted:

Jun 1, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stomach Neoplasms

Docetaxel

Oxaliplatin

Study Results

No Results Posted as of Jun 1, 2021