Stereotactic body radiation therapy after chemotherapy for unresectable perihilar cholangiocarcinoma: a multicenter phase II trial (The STRONG 2 trial)

• Conditions: Cholangiocarcinoma; perihilar; 10004606; 10019815

• Registration Number: NL-OMON56809
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 23

Inclusion Criteria

The initial translational part of the study will be performed in patients with
unresectable pCCA eligible for standard chemotherapy with cisplatin and
gemcitabine. After chemotherapy, the patients will proceed to SBRT if they are
still eligible based on the following inclusion and exclusion criteria (see
below). It may happen that patients do not give consent for the translational
part of the study, but they may wish to participate in the SBRT part of the
trial and vice versa.

Inclusion criteria translational part of the study:
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
standard chemotherapy (and immunotherapy, if applicable), and should meet all
of the following criteria pre-chemotherapy:
- pCCA according to the criteria of the Mayo Clinic, Rochester (22):
o Positive or strongly suspicious intraluminal brush cytology or biopsy or,
o 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
- T1-T4 (AJCC staging 8th edition), N0-N1-M0 (AJCC staging 8th edition),
radiologically or pathologically suspect
- 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

Inclusion criteria SBRT part of the study:
Additionally, 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
- Tumor visibility on CT
- Finished chemotherapy treatment with gemcitabine and cisplatin, preferably 8
cycles. If less cycles are given, patients are still eligible for this study
- Bilirubin <=1.5 times normal value, aspartate aminotransferase (AST)/alanine
transami-nase (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
- Able to start SBRT within 12 weeks after completion of chemotherapy and
immuno-therapy (if applicable)
- Written informed consent for the SBRT part of the study

Exclusion Criteria

Exclusion criteria translational part of the study
- 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

Exclusion criteria SBRT part of the study:
Progression (local or distant) during or after chemotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint with regards to the radiotherapy is local tumor control. With<br /><br>regards to the translational part of the study the aim is to explore the value<br /><br>of immunodynamics in peripheral blood for predicting progression-free survival<br /><br>in patients undergoing chemotherapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Toxicity, progression-free survival, overall survival, quality of life. </p><br>