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Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer

NCT ID: NCT00209651

Last Updated: 2007-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-12-31

Brief Summary

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To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative colorectal cancer.

Detailed Description

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A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Conditions

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Colorectal Cancer

Keywords

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Irinotecan, S-1, Phase II, colorectal cancer,

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Irinotecan and S-1

Group Type EXPERIMENTAL

Campto, Topotesin

Intervention Type DRUG

q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.

TS-1

Intervention Type DRUG

80 mg/m2, PO (oral) on day 1\~14 of each 28 day cycle.

Interventions

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Campto, Topotesin

q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.

Intervention Type DRUG

TS-1

80 mg/m2, PO (oral) on day 1\~14 of each 28 day cycle.

Intervention Type DRUG

Other Intervention Names

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irinotecan S-1

Eligibility Criteria

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Inclusion Criteria

1. Histological diagnosis of colorectal adenocarcinoma.
2. Measurable or assessable lesions.
3. Age: 18 \~ 75 years.
4. Performance Status (ECOG): 0 \~ 2.
5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
6. No history of treatment with CPT-11 or S-1.
7. No history of radiotherapy to the abdomen.
8. Oral intake of S-1 is possible.
9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine \<1.5 mg/dl (but if it is 1.0 \~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
10. Predicted survival for \>3 months.
11. Able to give written informed consent

Exclusion Criteria

1. Severe pleural effusion or ascites.
2. Metastasis to the central nervous system (CNS).
3. Active gastrointestinal bleeding.
4. Active infection.
5. Diarrhea (watery stools).
6. Uncontrolled ischemic heart disease.
7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
8. Active multiple cancer.
9. Severe mental disorder.
10. Pregnancy, possible pregnancy, or breast-feeding.
11. Flucytosine treatment
12. Gilbert's syndrome (4).
13. Judged to be ineligible for this protocol by the attending physician.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hokkaido University Hospital

OTHER

Sponsor Role collaborator

Hokkaido Gastrointestinal Cancer Study Group

OTHER

Sponsor Role lead

Principal Investigators

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Yoshito Komatsu, MD.PhD

Role: STUDY_CHAIR

Hokkaido Gastrointestinal Cancer Study Group

Locations

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Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status

Countries

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Japan

Other Identifiers

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IRIS

Identifier Type: -

Identifier Source: secondary_id

HGCSG0302

Identifier Type: -

Identifier Source: org_study_id