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

NCT03961867 | Unknown Phase 3 DMC

• 1 other identifier: SAHMO203
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  The interval from randomization to local recurrence, distant metastasis, death or the last follow-up

  3 year

Secondary Outcomes (2)

• overall survival

  5 year

• Treatment related Adverse Events

  1 year

Study Arms (2)

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

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.

Also known as: S-1

DS

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

Also known as: S-1

SOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510655, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; S 1 (combination); Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Jian Xiao, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shanshan Li, MD

CONTACT

86-20-38285497; lishsh89@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 23, 2019
• Study Start: September 15, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2025
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)