NCT01980407

Brief Summary

In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced gastric cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for phase_2 gastric-cancer

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 5, 2015

Status Verified

November 1, 2013

Enrollment Period

2.1 years

First QC Date

October 27, 2013

Last Update Submit

March 4, 2015

Conditions

Gastric Cancer

Keywords

S-1OxaliplatinLeucovorinGastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Evaluate the objective response rate followed by RECIST 1.1.

    6-8 weeks

Secondary Outcomes (4)

  • Adverse events

    1 year

  • Overall survival

    3 year

  • Progress free survival

    up to 9 weeks

  • Disease control rate

    up to 9 weeks

Study Arms (1)

SOL, single arm

EXPERIMENTAL

S-1 combined with leucovorin and oxaliplatin

Drug: S-1, leucovorin, oxaliplatin

Interventions

S-1, leucovorin, oxaliplatinDRUG

S-1 (20mg), capsule, 40-60mg, bid, p.o., day1-14； Leucovorin (15 mg), tablet, 30mg,Bid, p.o., day1-14; Oxaliplatin (50 mg), injection 85mg/m2, day1.

Also known as: S-1 (20mg):Taiho Pharmaceutical Co., Ltd.；, formyltetrahydrofolate (15mg), L-OHP (50mg)
SOL, single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years old
  • Histologically or cytologically documented gastric adenocarcinoma
  • Performance status (ECOG scale): 0-2
  • Life expectancy ≥ 3 months
  • No previous treatment(including: radiotherapy,chemotherapy and immunotherapy)
  • Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for adjuvant or neoadjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment.
  • WIth Measurable Target lesion
  • Patients should sign a written informed consent before study entry

You may not qualify if:

  • History of hypersensitivity to fluoropyrimidines, S-1, oxaliplatin or the ingredients product
  • Inadequate hematopoietic function: WBC≦5,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3
  • Inadequate organ function which is defined as below:
  • Total bilirubin \>2 pper limit of normal range (ULN); ALT / AST \> 2.5 upper limit of normal range (ULN) (\>5.0 x ULN if hepatic metastasis); serum creatinine \> 2 upper limit of normal range (ULN);
  • Symptomatic peripheral neuropathy ≥ NCI CTC AE grade 1;
  • Receiving a concomitant treatment with other fluoropyrimidines or fluorocytosine;
  • Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method;
  • Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication;
  • History of ventricular arrhythmia or congestive heart failure;
  • Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study;
  • Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical, paralytic or poor control diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jilin Provincial Tumor Hospital

Changchun, Jilin, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)LeucovorinOxaliplatinLong-Term Synaptic DepressionFormyltetrahydrofolates

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic ChemicalsNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Yue Zhang, MD, Ph.D

CONTACT

+86-0431-85872596JPCH2013@163.com

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
Head of Department of Integrated Traditional Chinese and Western Medicine

Study Record Dates

First Submitted

October 27, 2013

First Posted

November 11, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

March 5, 2015

Record last verified: 2013-11

Locations

CN(1)