IORT Versus CCRT for Pancreatic Cancer (IVCPC)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Pancreatic Cancer Stage IV

Treatments: Radiation: Three dimensional conformal radiation therapy (3D-CRT); Drug: Sequential chemotherapy; Radiation: Intraoperative radiotherapy (IORT); Drug: Concurrent chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02981641

2012AA022701

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intraoperative radiotherapy (IORT) Group

Experimental group

Description:

Radiotherapy (Total dose: 18\~22 Gy; Single dose: 18\~22 Gy; Frequency: 1) + Sequential chemotherapy

Treatment:

Radiation: Intraoperative radiotherapy (IORT)

Drug: Sequential chemotherapy

Concurrent Chemoradiotherapy (CCRT) Group

Experimental group

Description:

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

Treatment:

Drug: Concurrent chemotherapy

Drug: Sequential chemotherapy

Radiation: Three dimensional conformal radiation therapy (3D-CRT)