Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06493734

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

Led by Erasmus Medical Center · Updated on 2025-07-15

30

Participants Needed

8

Research Sites

13 weeks

Total Duration

On this page

Sponsors

E

Erasmus Medical Center

Lead Sponsor

D

Dutch Cancer Society

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of stereotactic body radiation therapy (SBRT) as an additional treatment after standard chemotherapy for patients with unresectable perihilar cholangiocarcinoma. This study aims to assess the effects of adding SBRT on tumor local control, toxicity, progression-free survival, overall survival, and quality of life. The study also explores immune system changes in the blood to predict progression-free survival in patients receiving chemotherapy. The study is a single-arm, multicenter phase II trial involving patients aged 18 and older with unresectable tumors eligible for gemcitabine-based chemotherapy. SBRT will be delivered in 15 fractions of 4 to 4.5 Gy, one fraction each weekday over three weeks, administered after completing chemotherapy, usually 8 cycles. Patients may still receive SBRT if chemotherapy is stopped early due to toxicity. The research includes an initial translational part focusing on immune markers and a treatment phase with SBRT. Participants will undergo regular assessments, including imaging scans to evaluate tumor response based on RECIST 1.1 criteria, blood tests to monitor immune responses and toxicity, and quality of life questionnaires using EQ-5D-5L, QLQ-C30, and QLQ-BIL21 tools. The primary outcome is local tumor control with a maximum follow-up of 42 months. Secondary outcomes include progression-free survival, overall survival, adverse events, stent-related events, and quality of life measures. Participants are expected to follow up for up to 42 months after inclusion.

CONDITIONS

Brief Title

Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with perihilar cholangiocarcinoma meeting Mayo Clinic criteria
  • One tumor mass
  • Tumor is unresectable or patient is unfit for surgery
  • Tumor stage T1-T4, lymph nodes N0-N2, no distant metastases (M0)
  • For liver cirrhosis patients: Child-Pugh A
  • Age 18 years or older
  • ECOG performance status 0-1
  • Eligible for gemcitabine-based chemotherapy
  • Measurable disease on CT or MRI scans according to RECIST 1.1
  • Completed or currently receiving gemcitabine-based chemotherapy
  • Bilirubin ≤ 3.0 times normal value
  • AST/ALT ≤ 5 times upper limit of normal
  • Platelets ≥ 50 x 10^9/l, Leukocytes > 1.5 x 10^9/l, Hemoglobin > 6 mmol/l
  • Able and willing to comply with follow-up schedule
  • Able to start SBRT within 12 weeks after chemotherapy
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Prior liver surgery or transplantation
  • Tumor extension into stomach, colon, duodenum, pancreas, or abdominal wall
  • Presence of ascites
  • Prior radiotherapy to the liver
  • Current pregnancy
  • Lymph nodes affected outside specified regions
  • Disease progression during or after chemotherapy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Chemotherapy

Duration - Duration of 8 cycles of chemotherapy

Participants receive gemcitabine-based chemotherapy to treat unresectable perihilar cholangiocarcinoma.

Visits as per chemotherapy schedule (not specified in detail)

Treatment

Duration - 3 weeks

Participants receive stereotactic body radiation therapy (SBRT) consisting of 15 fractions delivered on weekdays over 3 weeks after completing chemotherapy.

15 weekday visits (in-person) for radiation therapy

Follow-up

Duration - Up to 42 months

Participants are monitored for tumor control, survival, toxicity, and quality of life after completing radiation therapy.

Visits according to follow-up schedule (not specified in detail)

Trial Site Locations

Total: 8 locations

1

Antwerp University Hospital / Sint-Augustinus Gasthuiszusters

Wilrijk, Antwerp, Belgium, 2610

Not Yet Recruiting

2

University Hospital Brussels / Jules Bordet Institute

Brussels, Brussels Capital, Belgium, 1070

Not Yet Recruiting

3

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands, 6525 GA

Actively Recruiting

4

Maastricht University Medical Center+ / Maastro Clinic Maastricht

Maastricht, Limburg, Netherlands, 6229 ET

Actively Recruiting

5

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands, 1081 HV

Actively Recruiting

6

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands, 9713 GZ

Actively Recruiting

7

Erasmus MC

Rotterdam, South Holland, Netherlands, 3015 CD

Actively Recruiting

8

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands, 3584 CX

Actively Recruiting

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Research Team

A

Alejandra Méndez Romero, MD, PhD

S

Suus van Loosbroek, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

STRONG II trial: stereotactic body radiation therapy following chemotherapy for unresectable perihilar cholangiocarcinoma - a single-arm multicentre phase II study.

Suus Y van Loosbroek, Maaike T W Milder, Dirk de Ruysscher...

https://pubmed.ncbi.nlm.nih.gov/40669914