Prospective Cohort Study of Pancreatic Cancer Patients Treated With Proton Beam Therapy

• Conditions: Pancreas Cancer

• Registration Number: NCT04466189
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

Pancreatic cancer is one of the few cancers whose survival rate has not improved significantly due to high local recurrence and systemic metastasis despite advances in diagnosis and treatment over the past 40 years. And currently pancreatic cancer is the fifth leading cause of cancer-related death in Korea. For this reason, various anti-cancer therapies and radiotherapy have been tested to improve survival.

Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal tissue while maximizing radiation to tumor tissues due to the distinct physical properties of proton beam. Low toxicity have been reported. In addition, retrospective analysis of pancreatic cancer patients (n=37) who performed proton therapy (PBT) from June 2013 to July 2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months; Grade ≥ 3 Toxicity, 0%). In addition, gene polymorphisms of several genes (CD44, CD166, XAF1, MMP9, MUC1/4, SMAD7, SMAD4 (DPC), RRM1, ERCC1, HER2, etc.) in pancreatic cancer have been reported to be associated with recurrence and prognosis.

Detailed Description

Pancreatic cancer is one of the few cancers whose survival rate has not improved significantly due to high local recurrence and systemic metastasis despite advances in diagnosis and treatment over the past 40 years. And currently pancreatic cancer is the fifth leading cause of cancer-related death in Korea. For this reason, various anti-cancer therapies and radiotherapy have been tested to improve survival.

Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal tissue while maximizing radiation to tumor tissues due to the distinct physical properties of proton beam. Low toxicity have been reported. In addition, retrospective analysis of pancreatic cancer patients (n=37) who performed proton therapy (PBT) from June 2013 to July 2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months; Grade ≥ 3 Toxicity, 0%). In addition, gene polymorphisms of several genes (CD44, CD166, XAF1, MMP9, MUC1/4, SMAD7, SMAD4 (DPC), RRM1, ERCC1, HER2, etc.) in pancreatic cancer have been reported to be associated with recurrence and prognosis. Therefore, in this study, a prospective cohort of pancreatic cancer patients treated with proton beam therapy was established to analyze local control, survival, recurrence, toxicity, proton treatment plan information, gene expression information to analyze local control (LC), overall survival (OS), recurrence-free surival (RFS), and factors predicting treatment-related toxicity.

Study Timeline

• Study Start: 2018-09-21
• Status Verified: 2020-07
• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-09
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-13
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Pancreatic cancer patients scheduled to be proton beam therapy
• Agreed to participate in this study

Exclusion Criteria

-Disagreed to participate in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish a cohort of Pancreatic cancer patients treadted with proton beam therapy.	Up to 10 years	The primary outcome is to establish a prospective cohort of pancreatic cancer patients treadted with proton beam therapy. It is for exploring factors and models that predict local control, relapse, survival and treatment-related toxicity in patients with pancreatic cancer who have undergone proton therapy.

Trial Locations

Locations (1)

National Cancer Center Korea; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of