Study of S-1 Plus LV for Advanced Gastric Cancer

NCT02090153 | Completed Phase 2

• 1 other identifier: SL for AGC
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Advance Gastric Cancer,; S-1 plus leucovorin,; ORR,; OS,; TTP,; TTF,; Adverse events,; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  The primary endpoint is overall response rate,which equals the rate of patients with CR+PR.

  1 year

Secondary Outcomes (5)

• Progression free survival (PFS)

  1-1.5 years

• Overall survival (OS)

  1-2.5 years

• Time to treatment failure (TTF)

  1 year

• Disease control rate

  1 year

• Adverse Events (AEs)

  2 year

Study Arms (1)

S-1 plus LV

EXPERIMENTAL

All patients 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.

Drug: S-1; Drug: LV

Interventions

S-1 DRUG

40\~60mg bid，d1\~7 q2W

Also known as: tegafur/gimeracil/oteracil potassium

S-1 plus LV

LV DRUG

LV is given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest.

Also known as: Leucovorin

S-1 plus LV

Eligibility Criteria

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

You may qualify if:

• histologically confirmed 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 finished 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

You may not qualify if:

• a history of hypersensitivity to S-1 or LV, usage of drugs interacting with S-1
• serious concomitant conditions (severe heart disease, pulmonary fibrosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy ≥ grade 2, uncontrolled infections, psychogenic disorders, human immunodeficiency 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Taiho Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Gaungzhou, Guangdong, 510060, China

Location

Related Publications (2)

• 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):766-771. doi: 10.1093/annonc/mdp371. Epub 2009 Oct 14.

  PMID: 19828562 BACKGROUND

• He MM, Zhang DS, Wang F, Wang ZX, Yuan SQ, Wang ZQ, Luo HY, Ren C, Qiu MZ, Jin Y, Wang DS, Chen DL, Zeng ZL, Li YH, He YY, Hao YT, Guo P, Wang FH, Zeng YX, Xu RH. Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway. Cancer Chemother Pharmacol. 2017 Jan;79(1):69-79. doi: 10.1007/s00280-016-3209-1. Epub 2016 Dec 2.

  PMID: 27913881 DERIVED

Related 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.

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); Tegafur; Leucovorin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Ruihua Xu, Professor

  SunYat-sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of SunYat-sen University Cancer Center,head of medical oncology department

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 18, 2014
• Study Start: July 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

CN (1)