GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer

Kansai Hepatobiliary Oncology Group

Status and phase: Completed; Phase 3

Conditions: Biliary Tract Cancer

Treatments: Drug: Gemcitabine/Cisplatin; Drug: Gemcitabine/Cisplatin /S-1

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02182778

UMIN 000014371 (Registry Identifier)

KHBO1401

Details and patient eligibility

About

To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.

Full description

Gemcitabine/cisplatin combination therapy (GC) has been the standard palliative chemotherapy for patients with advanced biliary tract cancer (BTC). Investigators have evaluated the efficacy and safety of gemcitabine/cisplatin/S-1 combination therapy (GCS) for patients with advanced BTC and observed the promising efficacy. In this randomized phase Ⅲ study, investigators aimed to compare GCS with GC in patients with advanced BTC.

Enrollment: 246 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with cytologically or histologically proved biliary tract cancer
2. age >=20 years
3. Performance Status (PS) 0-2
4. No prior history of chemotherapy or radiotherapy.
5. Adequate bone marrow function (neutrophil count >=1,500/mm3, and platelet count >=100,000/mm3), liver function (total bilirubin >=3 mg/dL and AST/ALT >=150 IU/L), and renal function (creatinine clearance >=45 mL/min)
6. Adequate oral intake
7. Provided written informed consent -

Exclusion criteria

1. Patients with interstitial pneumonia or pulmonary fibrosis

2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months

3. Patients with severe active infection

4. Patients with moderate or marked pleural effusion or ascites necessitating drainage

5. Patients with a history of severe drug allergy

6. Patients with other serious comorbid disease

7. Patients who are pregnant or lactating, or have an intention to get pregnant

8. Patients with mental disease

9. Patients who are judged inappropriate for the entry into the study by the principle doctor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 2 patient groups

Gemcitabine/Cisplatin group

Experimental group

Description:

Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.

Treatment:

Drug: Gemcitabine/Cisplatin /S-1

Gemcitabine/Cisplatin /S-1 group

Experimental group

Description:

S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.

Treatment:

Drug: Gemcitabine/Cisplatin