Study of S-1 Plus LV for Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Phase II Study of S-1 Plus Leucovorin (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic and Recurrent Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090153
• Other study ID #: SL for AGC
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2014
• Last updated: March 14, 2014
• Start date: July 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.

Description:

Patients enrolled in this study were orally treated with S-1 in doses of 40 mg (body surface area (BSA)<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks. Treatment was continued until progressive disease (PD), unacceptable toxicity or patient refusal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically con?rmed metastatic or recurrent gastric cancer

• with at least one measurable lesion by RECIST criteria

• an age of = 18

• adequate oral intake

• no previous radiotherapy, immunotherapy, biotherapy, hormonotherapy and chemotherapy within 5 years (adjuvant chemotherapy without S-1 was allowed if ?nished 6 months before enrollment)

• an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• adequate bone marrow function, hepatic function and renal functions

Exclusion Criteria:

• a history of hypersensitivity to S-1 or LV, usage of drugs interacting with S-1

• serious concomitant conditions (severe heart disease, pulmonary ?brosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy = grade 2, uncontrolled infections, psychogenic disorders, human immunode?ciency virus infection, severe diarrhea, nausea, or vomiting, severe ascites or pleural effusion, etc.)

• extensive bone metastasis, brain metastasis or meningeal metastasis

• another synchronous cancer

• surgery within 3 weeks before enrollment

• participating in other clinical studies

• women who were or to be pregnant, nursing infants, and men who were to conceive children

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1
40~60mg bid,d1~7 q2W
• LV
LV is given simultaneously at a ?xed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Gaungzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

Koizumi W, Boku N, Yamaguchi K, Miyata Y, Sawaki A, Kato T, Toh Y, Hyodo I, Nishina T, Furuhata T, Miyashita K, Okada Y. Phase II study of S-1 plus leucovorin in patients with metastatic colorectal cancer. Ann Oncol. 2010 Apr;21(4):766-71. doi: 10.1093/annonc/mdp371. Epub 2009 Oct 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	The primary endpoint is overall response rate,which equals the rate of patients with CR+PR.	1 year	No
Secondary	Progression free survival (PFS)	Progression-free survival (PFS) was determined from the date of treatment to progression or death	1-1.5 years	No
Secondary	Overall survival (OS)	Overall survival (OS) was calculated from the date of treatment to death from any cause or the last date of follow-up.	1-2.5 years	No
Secondary	Time to treatment failure (TTF)	Time to treatment failure (TTF) was determined from the date of treatment to progression, death, refusal or interruption due to adverse events.	1 year	No
Secondary	Disease control rate	Disease control rate equals the rate of patients with CR+PR+SD.	1 year	No
Secondary	Adverse Events (AEs)	All treatment-related adverse events (AEs) were categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events.	2 year	Yes

External Links

•   Long-term outcomes and prognostic factors of patients with advanced gastric cancer treated with S-1 plus cisplatin combination chemotherapy as a first-line treatment.
•   S-1-Based Chemotherapy versus Capecitabine-Based Chemotherapy as First-Line Treatment for Advanced Gastric Carcinoma: A Meta-Analysis.