RecruitingNot ApplicableNCT06493734

Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma

Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma: A Multicenter Phase II Trial (The STRONG 2 Trial)


Sponsor

Erasmus Medical Center

Enrollment

30 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to evaluate the efficacy of stereotactic body radiation therapy (SBRT) as additional treatment after standard chemotherapy regarding tumor local control, toxicity, progression-free survival (PFS), overall survival and quality of life. In addition, the objective is to explore the value of immunodynamics in peripheral blood for predicting PFS in patients undergoing chemotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether giving targeted radiation (SBRT) after chemotherapy to people with a bile duct cancer near the liver (perihilar cholangiocarcinoma) that cannot be surgically removed can extend survival. **You may be eligible if...** - You have been diagnosed with perihilar cholangiocarcinoma (a bile duct cancer near the liver) that cannot be removed with surgery - Your diagnosis has been confirmed by biopsy or imaging - You are eligible to receive gemcitabine-based chemotherapy - Your case has been reviewed by a liver tumor specialist team **You may NOT be eligible if...** - Your cancer has spread to distant organs - You are not able to tolerate chemotherapy or radiation - You have serious liver problems beyond what is caused by the tumor - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic body radiation therapy

SBRT will be delivered in 15 fractions of 4 to 4.5Gy (risk-adapted), one fraction each weekday for 3 weeks.


Locations(8)

Antwerp University Hospital / Sint-Augustinus Gasthuiszusters

Wilrijk, Antwerp, Belgium

University Hospital Brussels / Jules Bordet Institute

Brussels, Brussels Capital, Belgium

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Maastricht University Medical Center+ / Maastro Clinic Maastricht

Maastricht, Limburg, Netherlands

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

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NCT06493734


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