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

NCT04466189 | Enrolling By Invitation

• 1 other identifier: NCC2018-0198
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer

Keywords

Proton Beam Therapy; Cohort Study

Outcome Measures

Primary Outcomes (1)

• Establish a cohort of Pancreatic cancer patients treadted with proton beam therapy.

  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.

  Up to 10 years

Study Arms (1)

Pancreatic Cancer Patients Treated With Proton Beam Therapy

Pancreatic Cancer Patients Treated With Proton Beam Therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pancreatic cancer patients over the age of 19

You may qualify if:

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

You may not qualify if:

• Disagreed to participate in this study

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Tae Hyun Kim

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: September 21, 2018
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

KR (1)