Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China (SCI-101)

May 17, 2015 updated by: Shen Lin

A Multicenter Feasibility Study With S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients With Untreated Metastatic Colorectal Cancer

S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on colorectal cancer. This study is to explore the feasibility of the SOL regimen on efficacy and tolerability on Chinese colorectal cancer patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • Endpoints:
  • Primary endpoints: adverse drug reaction

  • Secondary endpoints:

    • Overall Response Rate：ORR
    • Progress Free Survival: PFS
    • Time to Treatment Failure：TTF

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100036
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Advanced unresectable or recurrent colorectal cancer patients which meet the following criteria:

    • Willing to sign ICF
    • Could orally take investigational product
    • Pathology diagnosis is adenocarcinoma
    • Above 20 years
    • No previous treatment(including: radiotherapy,chemotherapy and immunotherapy)
    • For recurrent cases, if the patient had received adjuvant chemotherapy that didn't include S-1 and L-OHP in 180 days ago, he/she could be enrolled in
    • With target lesions with diameter which is longer than 1cm in spiral CT or MRI examination within 30 days

  • Lab test within 15 days meet following criteria

    • Hemoglobin higher than 9.0g/dL
    • Leukocyte higher than 12,000/mm3
    • Neutrophil higher than 2,000/mm3
    • PLT higher than 10.0 104/mm3
    • Bilirubin lower than 1.5 times of upper limit of normal range
    • AST,ALT,ALP lower than 2.5 times of upper limit of normal range
    • Creatinine lower than upper limit of normal range

When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range

  • ECOG 0 or 1
  • Expected survival time more than 90 days

Exclusion Criteria:

  • The patient who meet the following criteria should be excluded from this trial
  • Patients who have severe drug allergic history(including: platinum related drugs,5-FU,FT,LV,5-HT3 receptor antagonist)
  • Attended other clinical trial within 4 weeks
  • Received transfusion of blood,related products or G-CSF within 15 days
  • Received surgery within 4 weeks and the effect hadn't vanished
  • Have diarrhea
  • Have complication of active infection(infection caused fever higher than 38℃)
  • Have complication of poor controlled hypercalcemia,hypertension,diabetes
  • Have complication of severe ECG abnormal or other heart disease which will affect clinical treatment(including: cardiac dysfunction,myocardial infarction,angina)
  • Have complication of severe pulmonary disease(including:interstitial pneumonia,pulmonary fibrosis,severe emphysema)
  • Have complication of psychiatric disorder which will affect clinical treatment or have history of CNS disease
  • Have complication of active gastrointestinal bleeding
  • Have pleural effusion,ascites or pericardial effusion that need drainage
  • Have complication of multiple bone metastasis
  • Have severe complication(including:ileus,renal insufficiency,hepatic insufficiency,cerebrovascular disturbance)
  • Have brain metastasis or suspicious brain metastasis
  • Have active multiple primary cancer
  • Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
  • Investigator judge not eligible to this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SOL
single arm
Drug: S-1, leucovorin, oxaliplatin
S-1(20mg、25mg), capsule, 40~60mg, Bid,p.o., day1~7； LV (25 mg), tablet, 25mg,Bid,p.o., day1~7； L-OHP (50 mg),injection 85mg/m2, day1. repeated at every 2 weeks cycle till disease progression.
Other Names:
  • S-1(20mg、25mg)--Taiho Pharmaceutical Co., Ltd.；
  • LV (25 mg)；
  • L-OHP (50 mg)--Sanofi Aventis Co., Ltd.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: from first administration till 28 days after last dosage
from first administration till 28 days after last dosage

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, and follow up till disease progression or withdrawal from study due to intolerable adverse events (AE)
Time Frame: every 6 weeks
every 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shen Lin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
307 Hospital of PLA
Tianjin Medical University Cancer Institute and Hospital
Beijing Union Hosptial
Hebei Provincial Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SOL feasibility study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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