Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer
This trial is active, not recruiting.
|Treatments||campto, topotesin, ts-1|
|Sponsor||Hokkaido Gastrointestinal Cancer Study Group|
|Collaborator||Hokkaido University Hospital|
|Start date||January 2004|
|End date||December 2007|
|Trial size||40 participants|
|Trial identifier||NCT00209651, HGCSG0302, IRIS|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Irinotecan and S-1
objective tumor response
time frame: 1-year
Response duration, time to progression, overall survival, and safety will also be assessed.
time frame: 2-years
Male or female participants from 18 years up to 75 years old.
- Histological diagnosis of colorectal adenocarcinoma.
- Measurable or assessable lesions.
- Age: 18 ~ 75 years.
- Performance Status (ECOG): 0 ~ 2.
- 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.
- No history of treatment with CPT-11 or S-1.
- No history of radiotherapy to the abdomen.
- Oral intake of S-1 is possible.
- 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).
- Predicted survival for >3 months.
- Able to give written informed consent
- Severe pleural effusion or ascites.
- Metastasis to the central nervous system (CNS).
- Active gastrointestinal bleeding.
- Active infection.
- Diarrhea (watery stools).
- Uncontrolled ischemic heart disease.
- Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
- Active multiple cancer.
- Severe mental disorder.
- Pregnancy, possible pregnancy, or breast-feeding.
- Flucytosine treatment
- Gilbert's syndrome (4).
- Judged to be ineligible for this protocol by the attending physician.
|Official title||Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302|
|Description||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.|
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