IORT Versus CCRT for Pancreatic Cancer

Pancreatic Cancer Stage IV Clinical Trial

— IVCPC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02981641
• Other study ID #: 2012AA022701
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2016
• Last updated: November 30, 2016
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Jianwei Zhang, Ph.D.
• Phone: +8613581841816
• Email: panchutong[@]163.com
• Is FDA regulated: No
• Health authority: National High-tech R&D Program (863 Program):China
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer Stage IV
• Pancreatic Neoplasms

Intervention

Radiation:
• Intraoperative radiotherapy (IORT)
Total dose: 18~22 Gy; Single dose: 18~22 Gy; Frequency: 1

Drug:
• Sequential chemotherapy
Sequential chemotherapy

Radiation:
• Three dimensional conformal radiation therapy (3D-CRT)
Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30

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

Locations

Country	Name	City	State
China	CancerIHCAMS	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overal survival	OS	3 years	Yes
Secondary	Disease-specific survival	DSS	3 years	Yes
Secondary	Progression-free survival	PFS	3 years	Yes
Secondary	Local control rate	LCR	3 years	Yes