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Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302

Phase 2
18 Years
75 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302

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.

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

objective tumor response

Outcome Time Frame:


Principal Investigator

Yoshito Komatsu, MD.PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hokkaido Gastrointestinal Cancer Study Group


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

January 2004

Completion Date:

December 2007

Related Keywords:

  • Colorectal Cancer
  • Irinotecan, S-1, Phase II, colorectal cancer,
  • Colorectal Neoplasms
  • Gastrointestinal Neoplasms