Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma

NCT06493734 | Recruiting DMC

• 1 other identifier: NL86210.078.24
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Klatskin Tumor

Keywords

Klatskin tumor; Perihilar cholangiocarcinoma; Stereotactic body radiation therapy

Outcome Measures

Primary Outcomes (1)

• Local tumor control

  Local tumor control is defined as time from inclusion to local radiological progression. Definition of progression is based on response evaluation criteria in solid tumors (RECIST) 1.1. In RECIST 1.1, response of a tumor to treatment is defined as either complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).

  42 months (maximum follow-up time)

Secondary Outcomes (7)

• Progression-free survival (PFS)

  42 months (maximum follow-up time)

• Overall survival (OS)

  42 months (maximum follow-up time)

• Adverse events

  42 months (maximum follow-up time)

• Biliary stent-related events (SRE)

  42 months (maximum follow-up time)

• Quality of life (QoL) - EQ-5D-5L

  36 months

Study Arms (1)

Stereotactic body radiation therapy

EXPERIMENTAL

Single-arm study

Radiation: Stereotactic body radiation therapy

Interventions

Stereotactic body radiation therapy RADIATION

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

Stereotactic body radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in the translational part of the study, a subject must be discussed in a liver tumor board, should be eligible for gemcitabine-based chemotherapy (and immunotherapy, if applicable), and should meet all of the following criteria pre-chemotherapy:
• Perihilar cholangiocarcinoma (pCCA) according to the criteria of the Mayo Clinic, Rochester: a positive or strongly suspicious intraluminal brush cytology or biopsy, or a radiographic malignant appearing stricture plus either: CA 19-9\>100 U/ml in the absence of acute bacterial cholangitis, or polysomy on fluorescence in situ hybridization (FISH), or a well-defined mass on cross sectional imaging
• One tumor mass
• Unresectable tumor or patient deemed unfit for surgery
• T1-T4 (AJCC staging 8th edition), N0-N2-M0 (AJCC staging 8th edition), radiologically or pathologically suspect. N1 is defined as one to three affected lymph nodes typically involving the hilar, cystic duct, common bile duct, hepatic artery, posterior pancreatoduodenal, and portal vein lymph nodes. N2 is defined as four or more affected lymph nodes from the sites described for N1. Endoscopic ultrasound (EUS) is leading in identifying pathological lymph nodes compared to CT.
• In case of (underlying) liver cirrhosis: Child-Pugh A
• Age ≥ 18 years
• ECOG performance status 0-1
• Written informed consent for the translational part of the study
• In addition to the criteria mentioned above, patients should meet the following criteria to be eligible for the treatment with SBRT:
• Measurable disease to be selected as a target on a computed tomography (CT) or magnetic resonance imaging (MRI) scan, according to RECIST 1.1 criteria
• Finished gemcitabine-based chemotherapy treatment, preferably 8 cycles. If less cycles are given, patients are still eligible for this study
• Bilirubin ≤3.0 times normal value, aspartate aminotransferase (AST)/alanine transaminase (ALT) ≤5 times ULN
• Platelets ≥ 50x10E9/ l, Leukocytes \> 1.5x10E9/l, Hemoglobin (Hb) \> 6 mmol/l
• Willing and able to comply to the follow-up schedule

You may not qualify if:

• Prior surgery or transplantation of the liver
• Tumor extension in stomach, colon, duodenum, pancreas or abdominal wall
• Ascites
• Prior radiotherapy to the liver
• Current pregnancy
• Progression (local or distant) during or after chemotherapy

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Dutch Cancer Society: collaborator

Study Sites (8)

Antwerp University Hospital / Sint-Augustinus Gasthuiszusters

Wilrijk, Antwerp, 2610, Belgium

NOT YET RECRUITING

University Hospital Brussels / Jules Bordet Institute

Brussels, Brussels Capital, 1070, Belgium

NOT YET RECRUITING

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Maastricht University Medical Center+ / Maastro Clinic Maastricht

Maastricht, Limburg, 6229 ET, Netherlands

RECRUITING

Amsterdam University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015 CD, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

RECRUITING

Related Publications (1)

• van Loosbroek SY, Milder MTW, de Ruysscher D, Vaes RDW, den Toom W, Willemssen F, Eskens F, Homs MYV, Groot Koerkamp B, van Driel LMJW, Seppenwoolde Y, van Werkhoven E, Intven M, Haj Mohammad N, de Bruijne J, Versteijne E, Bruynzeel AM, Brandts F, Erdmann JI, Westdorp H, Braam PM, Tjwa ETTL, Bouchart C, Demols A, Gulyban A, Buijsen J, de Vos-Geelen J, Dewulf M, Joye I, Vandamme T, Vonghia L, de Groot DJ, Dieters M, Ubbels FJF, Hoogwater FJH, Heijmen B, Mendez Romero A PHD. STRONG II trial: stereotactic body radiation therapy following chemotherapy for unresectable perihilar cholangiocarcinoma - a single-arm multicentre phase II study. BMJ Open. 2025 Jul 16;15(7):e097545. doi: 10.1136/bmjopen-2024-097545.

  PMID: 40669914 DERIVED

MeSH Terms

Conditions

Klatskin Tumor

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alejandra Méndez Romero, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandra Méndez Romero, MD, PhD

CONTACT

+31 (0)10 7035792; a.mendezromero@erasmusmc.nl

Suus van Loosbroek, MSc

CONTACT

s.vanloosbroek@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 10, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); NL (6)