Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

NCT ID: NCT01333124

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-28
• Study Completion Date: 2017-12-31

Brief Summary

This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.

Detailed Description

The primary objective of this study is to evaluate the complete (R0) resection rate for patients with and resectable pancreatic cancer treated with preoperative chemoradiotherapy and curative surgery. An experimental arm that result a complete resection rate of at least 90% would merit further study. With 90% power to reject that null hypothesis that the true complete resection rate is ≤75% with a type I error level of 5%, evaluable 53 patients are required. Considering the 20% unevaluable patients due to the immediate distant metastasis after treatment7, 8, 17 and 10% follow up loss, a total of 64 eligible patients will be enrolled.

Conditions

Resectable Pancreatic Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation: chemoradiotherapy with Gemcitabine

Radiation: chemoradiotherapy with Gemcitabine All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent.

Group Type: EXPERIMENTAL

chemoradiotherapy with Gemcitabine

Intervention Type: RADIATION

All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent.

Radiation: chemoradiotherapy with Gemcitabine

Intervention Type: RADIATION

Radiation: chemoradiotherapy with Gemcitabine

Interventions

chemoradiotherapy with Gemcitabine

All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent.

Intervention Type: RADIATION

Radiation: chemoradiotherapy with Gemcitabine

Radiation: chemoradiotherapy with Gemcitabine

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patients with resectable pancreatic adenocarcinoma
• Age over 18 years old and younger than 70 year old
• Performance status (ECOG scale): 0-1
• Adequate organ functions

• Hb ≥9.0 g/dl
• ANC ≥1,500/mm3
• PLT ≥100,000/mm3
• Liver function: Total Bilirubin ≤3.0 mg/dl AST/ALT/ALP ≤3× upper limit of normal
• Creatinine ≤1.5 ULN
• Patients should sign a written informed consent before study entry.

Exclusion Criteria

• Tumor type other than adenocarcinoma
• Unresectable for resection on preoperative evaluation
• Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
• Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
• Prior radiotherapy
• Major surgery within 4 weeks prior to study treatment
• Serious illness or medical conditions, as follows;

• congestive heart failure (NYHA class III or IV)
• unstable angina or myocardial infarction within the past 6 months,
• significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
• uncontrolled hypertension
• hepatic cirrhosis( ≥ Child class B)
• interstitial pneumonia, pulmonary adenomatosis
• psychiatric disorder that may interfere with and/or protocol compliance
• unstable diabetes mellitus
• uncontrolled ascites or pleural effusion
• active infection
• Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
• Pregnant or lactating woman
• Women of child bearing potential not using a contraceptive method
• Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
• Any patients judged by the investigator to be unfit to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sang-Jae Park

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang-Jae Park, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCCCTS-10-500

Identifier Type: -

Identifier Source: org_study_id