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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03961867
• Other study ID #: SAHMO203
• Status: Recruiting
• Phase: Phase 3
• Start date: September 15, 2020
• Est. completion date: September 2025

Study information

• Verified date: May 2021
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Shanshan Li, MD
• Phone: 86-20-38285497
• Email: lishsh89[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: September 2025
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	The interval from randomization to local recurrence, distant metastasis, death or the last follow-up	3 year
Secondary	overall survival	The interval from randomization to death or the last follow-up	5 year
Secondary	Treatment related Adverse Events	According to CTC version 5	1 year