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Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

Primary Purpose

Resectable Pancreatic Carcinoma

Status

Terminated

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

chemoradiotherapy with Gemcitabine

Radiation: chemoradiotherapy with Gemcitabine

About this trial

This is an interventional treatment trial for Resectable Pancreatic Carcinoma focused on measuring Preoperative chemoradiotherapy with Gemcitabine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cancer Center, Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation: chemoradiotherapy with Gemcitabine

Arm Description

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.

Outcomes

Primary Outcome Measures

Complete resection rate

To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).

Secondary Outcome Measures

Clinical outcomes

To investigate the association between radiologic, histopathologic response, complete resection rate of preoperative chemoradiotherapy with gemcitabine and clinical outcomes, such overall survival and disease-free survival.

The association between biomolecular markers and clinical outcomes

To investigate the association between biomolecular markers and clinical outcomes (including tumor response and complete resection rate, etc.)

The feasibility and compliance

To evaluate the feasibility and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of preoperative chemoradiotherapy with gemcitabine for resectable pancreatic cancer.

Full Information

NCT ID

NCT01333124

First Posted

April 1, 2011

Last Updated

April 2, 2020

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT01333124

Brief Title

Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

Official Title

A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Terminated

Why Stopped

Recruitment delay

Study Start Date

September 28, 2011 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resectable Pancreatic Carcinoma

Keywords

Preoperative chemoradiotherapy with Gemcitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiation: chemoradiotherapy with Gemcitabine

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

chemoradiotherapy with Gemcitabine

Intervention Description

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

Intervention Name(s)

Radiation: chemoradiotherapy with Gemcitabine

Intervention Description

Radiation: chemoradiotherapy with Gemcitabine

Primary Outcome Measure Information:

Title

Complete resection rate

Description

To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).

Time Frame

Within the first 30 days after surgery

Secondary Outcome Measure Information:

Title

Clinical outcomes

Description

Time Frame

Up to 3years from a initial follow-up

Title

The association between biomolecular markers and clinical outcomes

Description

To investigate the association between biomolecular markers and clinical outcomes (including tumor response and complete resection rate, etc.)

Time Frame

Up to 3years until study closed

Title

The feasibility and compliance

Description

To evaluate the feasibility and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of preoperative chemoradiotherapy with gemcitabine for resectable pancreatic cancer.

Time Frame

Up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang-Jae Park, M.D.

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center, Korea

City

Goyang-si

State/Province

Gyeonggi-do

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

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