IORT Versus CCRT for Pancreatic Cancer (IVCPC)

November 30, 2016 updated by: Chengfeng Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Intraoperative Radiotherapy (IORT) Versus Concurrent Chemoradiotherapy (CCRT) for Pancreatic Cancer

The purpose of this study is to find the better radiation therapy between intraoperative radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The trial is funded by National High-tech R&D Program (863 Program). The trial is prepared to be registered on the clinicaltrail.gov.

Quality assurance plan: Every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of The First Affiliated Hospital of China Medical University Data check: The investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant. Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 100 participants to take part in the trail. The investigators can recruit about 120 participants every year according to previous experiences, so the investigators should recruit at least for one years.

Plan for missing data: The investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.

Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of survival time between the two groups, and the local control rate of the two groups would be compared by chi square test. Statistical analyses would be performed by using IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P < 0.05.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • CancerIHCAMS
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed as locally advanced pancreatic cancer.
  • Cannot be treated by surgical resection.

Exclusion Criteria:

  • Treated by chemotherapy or radiotherapy before.
  • With distant organ metastasis.
  • Cannot tolerate surgery (Intraoperative radiotherapy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoperative radiotherapy (IORT) Group
Radiotherapy (Total dose: 18~22 Gy; Single dose: 18~22 Gy; Frequency: 1) + Sequential chemotherapy
Radiation: Intraoperative radiotherapy (IORT)
Total dose: 18~22 Gy; Single dose: 18~22 Gy; Frequency: 1
Other Names:
  • IORT
Drug: Sequential chemotherapy
Sequential chemotherapy
Other Names:
  • SC
Experimental: Concurrent Chemoradiotherapy (CCRT) Group
Three dimensional conformal radiation therapy (3D-CRT) (Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30) + Concurrent chemotherapy (Gemcitabine(GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d) + Sequential chemotherapy
Drug: Sequential chemotherapy
Sequential chemotherapy
Other Names:
  • SC
Radiation: Three dimensional conformal radiation therapy (3D-CRT)
Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30
Other Names:
  • 3D-CRT
Drug: Concurrent chemotherapy
Gemcitabine (GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d
Other Names:
  • CC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overal survival
Time Frame: 3 years
OS
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-specific survival
Time Frame: 3 years
DSS
3 years
Progression-free survival
Time Frame: 3 years
PFS
3 years
Local control rate
Time Frame: 3 years
LCR
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Chengfeng Wang, B.A., National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012AA022701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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