To assess feasibility of SBRT as add on treatment after standard chemotherapy.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is feasibility measured by radiotherapy
induced toxicity according to CTC v4.0.3.
Secondary outcome
-Quality of life
-Local progression
-Progression free survival
-Overall survival
-Cellular radiosensitivity.
Background summary
For patients with perihilar cholangiocarcinoma, surgery is the only treatment
modality that can result in cure. Unfortunately, in the majority of these
patients the tumors are found to be unresectable at presentation due to local
invasive tumor growth or the presence of distal metastases. For patients with
unresectable cholangiocarcinoma palliative chemotherapy is the standard
treatment yielding an estimated median overall survival of 12-15.2 months.
There is no evidence from randomized trials that support the routine use of
stereotactic body radiation therapy (SBRT) for cholangiocarcinoma. However,
small and most often retrospective studies combining chemotherapy with SBRT
showed promising results with overall survival reaching up to 33-35 months.
Based upon these observations, we designed a local feasibility trial with SBRT
after chemotherapy in patients with unresectable perihilar cholangiocarcinoma
in order to try to confirm the observed tolerability of adding SBRT to standard
chemotherapy. The expected time to include the required patients for this pilot
study will be one year.
Study objective
To assess feasibility of SBRT as add on treatment after standard chemotherapy.
Study design
Local feasibility trial.
Intervention
SBRT will be delivered in 15 fractions of 3 to 4.5Gy after 8 cycles of
chemotherapy. In case of toxicity causing premature termination of systemic
treatment, the patient can still proceed to SBRT.
Study burden and risks
Studies evaluating toxicity of SBRT delivered in 15 fractions for intrahepatic
cholangiocarcinoma provide evidence that SBRT is a relatively safe treatment
with acceptable complication risks.
The risk of biliary toxicity with the SBRT protocol used in this trial is
expected to be <10%. Dose limitations for the surrounding organs comply with
internationally accepted recommendations such as the Quantitative Analyses of
Normal Tissue Effects in the Clinic (QUANTEC). Expected associated toxicity
such as stomach or bowel perforation, is expected to be low (<5%). The main
risk associated with fiducial marker implantation is intrahepatic bleeding,
which is expected to be rare. In order to minimize this risk of complications,
the implantation will be carried out by a well-trained interventional
radiologist. Patient will remain hospitalized during at least 2-3 hours after
the implantation to assess for any procedural complications.
A DSMB will be installed if the Ethical Committee estimates that this is
needed due to the fact that this is a feasibility study. However, the expected
risk associated with the participation in this trial is low. No interim
analysis is planned for this study.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Patients diagnosed with perihilar cholangiocarcinoma according to the criteria of the Mayo Clinic:
-Positive or strongly suspicious intraluminal brush 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 FISH, or
-a well-defined mass on cross sectional imaging
-One tumor mass ;
-Unresectable tumor;
-Finished chemotherapy treatment with Gemcitabine and Cisplatin, preferably 8 cycles; If less cycles are given, patients are still eligible for this study.
-T1-T4 (AJCC staging 7th edition), before chemotherapy;
-N0-N1 (AJCC staging 7th edition), radiologically or pathologically suspect, before chemotherapy;
-Measurable disease to be selected as a target on CT/MRI-scan, according to RECIST criteria, after chemotherapy within 6 weeks prior to inclusion
-Tumor visibility on CT;
-If liver cirrhosis is present, it should be well compensated, with Child-Pugh grade A;
-Age * 18 years;
-ECOG performance status 0-1;
-Bilirubin *1.5 times normal value, AST/ALT *5 times ULN, within 6 weeks prior to inclusion;
-Platelets * 50x10E9/ l, Leukocytes > 1.5x10E9/l, Hb > 6 mmol/l, within 6 weeks prior to inclusion;
-Written informed consent, after chemotherapy;
-Willing and able to comply to the follow-up schedule;
-Able to start SBRT within 12 weeks after completion of chemotherapy.
Exclusion criteria
-Eligibility for resection;
-Prior surgery or transplantation;
-Multifocal tumor;
-Tumor extension in stomach, colon, duodenum, pancreas or abdominal wall;
-N2, (AJCC staging 7th edition), radiologically or pathologically suspect, before chemotherapy;
-Distant metastases;
-Progression (local or distant) during or after chemotherapy
-Ascites;
-Previous radiotherapy to the liver;
-Current pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60588.078.17 |