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A Phase II Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Pancreatic Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Carcinoma Non-resectable

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Trial Information

A Phase II Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Pancreatic Carcinoma


The primary endpoint is feasibility and compliance of induction chemotherapy with
gemcitabine and cisplatin followed by CRT for locally advanced unresectable pancreatic
cancer. Previous studies showed that approximately 20% of patients with locally advanced
disease developed the early distant metastasis.[6, 7] Thus, it will be expected that at
least 80% of total patients will be eligible for induction chemotherapy after completion of
induction chemotherapy. An experimental arm that result a compliance of 80% would merit
further study. If the true compliance rate of the patients who will eligible for CRT is ≤
60%, null hypothesis will be rejected with a power of 80% and a type I error of 5%. Thus,
the required number of evaluable patients is 24. Considering the 10% follow-up loss and 20%
distant metastasis rate after induction chemotherapy, a total of 34 eligible patients will
be enrolled.


Inclusion Criteria:



- Pathologically confirmed adenocarcinoma of the pancreas

- Unresectable locally advanced disease base on institutional standard criteria of
unresectability disease following radical surgery. There is no evidence of metastatic
disease in the major viscera and no peritoneal seeding

- Patients with biliary or gastroduodenal obstruction must have drainage prior to
starting chemoradiation

- All malignant disease must be encompassable within a single irradiation field
(15x15cm maximum)

- All patients must have radiographically assessable disease

- No previous irradiation to the planned field

- Age of ≥ 18 years

- performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) score

- Required Entry Laboratory Parameters WBC count ≥ 1,000/mm3; hemoglobin level ≥ 7.5
g/dL; platelet count ≥ 100,000/mm3; total bilirubin ≤ 3.0 mg/dL (Patients with
elevated bilirubin due to obstruction should be stented and their bilirubin should be
decrease ≤ 3.0 mg/dL prior to study entry); creatinine ≤ 3.0 mg/dL

- Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.

- Signed informed consent form prior to study entry

Exclusion Criteria:

- There is evidence of metastasis in the major viscera or peritoneal seeding.

- Age of < 18 years

- Previous history of RT adjacent to planned field

- Poor performance status of 2 to 4 on the Eastern Cooperative Oncology Group (ECOG)
score

- Pregnant or breast feeding status

- Previous history of uncontrolled other malignancies within 2 years

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

feasibility and compliance

Outcome Description:

to evaluate acute and late toxicity of induction chemotherapy with gemcitabine and cisplatin followed by chemoradiotherapy for unresectable pancreatic cancer.

Outcome Time Frame:

Up to 1 year

Safety Issue:

Yes

Principal Investigator

Woo Jin Lee, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

NCCCTS-11-567

NCT ID:

NCT01593475

Start Date:

March 2012

Completion Date:

August 2014

Related Keywords:

  • Pancreatic Carcinoma Non-resectable
  • Carcinoma
  • Pancreatic Neoplasms

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