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New treatment option for Klatskin Tumor
Official title Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma
ClinicalTrials.gov ID: NCT06493734
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Perihilar cholangiocarcinoma (pCCA) according to the criteria of the Mayo Clinic, Rochester: a positive or strongly suspicious intraluminal brush...
- 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...
You likely can't join if
- 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
See the full eligibility 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 gemcitabine-based 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...
- 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...
- 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 SBRT part of the study: In addition to the criteria mentioned above, patients should meet the following criteria to be eligible for the treatment with...
- 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
- 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
- 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
- Affected lymph nodes outside the regions described in the inclusion criteria Exclusion criteria SBRT part of the study: Progression (local or distant) during or after chemotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Wilrijk, Antwerp, Belgium
- Brussels, Brussels Capital, Belgium
- Nijmegen, Gelderland, Netherlands
- Maastricht, Limburg, Netherlands
- Amsterdam, North Holland, Netherlands
- Groningen, Provincie Groningen, Netherlands
- Rotterdam, South Holland, Netherlands
- Utrecht, Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wilrijk, Antwerp, Belgium; Brussels, Brussels Capital, Belgium; Nijmegen, Gelderland, Netherlands; Maastricht, Limburg, Netherlands; Amsterdam, North Holland, Netherlands; Groningen, Provincie Groningen, Netherlands and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.