Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic Cancer

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: gemcitabine, cisplatin, capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01396668

H-0412-138-005

Details and patient eligibility

About

This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Full description

The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• unresectable locally advanced pancreatic cancer

• no distant metastasis

• histologically confirmed adenocarcinoma of pancreas

• 18-75 of age

• ECOG performance status 0-2

• normal marrow function :

  • WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

• normal liver function :

  --Bilirubin no greater than 2.0 mg/dL AST less than 3 times upper limit of normal (ULN)

• normal renal function :

  --Creatinine no greater than 1.5 times ULN

• signed informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)