Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493734
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-01
Brief Title:
Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma A Multicenter Phase II Trial The STRONG 2 Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRONG II
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
Detailed Description:
Rationale
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 12-152 months
There is no evidence from randomized trials that support the routine use of stereotactic body radiation therapy SBRT for cholangiocarcinoma The STRONG phase I feasibility study showed favorable outcomes regarding safety and the therapy was generally well tolerated Based upon these observations a phase II multi-center study with SBRT after chemotherapy in patients with unresectable perihilar cholangiocarcinoma is proposed in order to further research the efficacy of adding SBRT to standard chemotherapy
In addition an explorative translational research component is part of the study in which peripheral immunodynamics specifically myeloid nuclear factor kappa-light-chain enhancer of activated B cells NF-kB signaling and interferon-stimulated genes ISG responses within the myeloid cells may help to predict survival after chemotherapy and may also help to predict the value of additional treatment with radiotherapy
Objective
The objective of this study is to evaluate the efficacy of SBRT as additional treatment after standard chemotherapy regarding tumor local control toxicity progression-free survival PFS overall survival and quality of life In addition to explore the value of immunodynamics in peripheral blood for predicting PFS in patients undergoing chemotherapy
Study design
Single-arm multicenter phase II study
Study population
The initial translational part of the study will be performed in patients diagnosed with unresectable perihilar cholangiocarcinoma 18 years of age or older T1-4 N0-N1-M0 AJCC staging 8th edition eligible for standard chemotherapy with cisplatin and gemcitabine Exclusion criteria are tumor extension into either stomach colon duodenum pancreas or abdominal wall After completion of chemotherapy and no local or distant progression during or after chemotherapy the patients will proceed to SBRT if they are still eligible based on the inclusion and exclusion criteria It may occur 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 Sample size will be 30 patients
Intervention
SBRT will be delivered in 15 fractions of 4 to 45Gy after 8 cycles of chemotherapy In case of toxicity causing premature termination of systemic treatment the patient can still proceed to SBRT
Main study parametersendpoints
The primary endpoint of this study is local tumour control defined as time from inclusion to local radiological progression Definition of progression is based on response evaluation criteria in solid tumours RECIST 11
Secondary endpoints
Toxicity according to the Common Toxicity Criteria for Adverse Events CTCAE V50 grading system
Progression-free survival defined as time from inclusion until radiological progression Definition of progression is based on RECIST 11
Overall survival defined as time from inclusion until death from any cause
Quality of life QoL assessed by means of the EuroQol EQ-5D-5L measure of health outcome in general population and the European Organisation for Research and Treatment of Cancer EORTC QLQ-C30 QoL specific for patients with cancer with the supplementary module EORTC QLQ-BIL21 specific for CCA and gallbladder cancer
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 12-152 months
There is no evidence from randomized trials that support the routine use of stereotactic body radiation therapy SBRT for cholangiocarcinoma The STRONG phase I feasibility study showed favorable outcomes regarding safety and the therapy was generally well tolerated Based upon these observations a phase II multi-center study with SBRT after chemotherapy in patients with unresectable perihilar cholangiocarcinoma is proposed in order to further research the efficacy of adding SBRT to standard chemotherapy
In addition an explorative translational research component is part of the study in which peripheral immunodynamics specifically myeloid nuclear factor kappa-light-chain enhancer of activated B cells NF-kB signaling and interferon-stimulated genes ISG responses within the myeloid cells may help to predict survival after chemotherapy and may also help to predict the value of additional treatment with radiotherapy
Objective
The objective of this study is to evaluate the efficacy of SBRT as additional treatment after standard chemotherapy regarding tumor local control toxicity progression-free survival PFS overall survival and quality of life In addition to explore the value of immunodynamics in peripheral blood for predicting PFS in patients undergoing chemotherapy
Study design
Single-arm multicenter phase II study
Study population
The initial translational part of the study will be performed in patients diagnosed with unresectable perihilar cholangiocarcinoma 18 years of age or older T1-4 N0-N1-M0 AJCC staging 8th edition eligible for standard chemotherapy with cisplatin and gemcitabine Exclusion criteria are tumor extension into either stomach colon duodenum pancreas or abdominal wall After completion of chemotherapy and no local or distant progression during or after chemotherapy the patients will proceed to SBRT if they are still eligible based on the inclusion and exclusion criteria It may occur 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 Sample size will be 30 patients
Intervention
SBRT will be delivered in 15 fractions of 4 to 45Gy after 8 cycles of chemotherapy In case of toxicity causing premature termination of systemic treatment the patient can still proceed to SBRT
Main study parametersendpoints
The primary endpoint of this study is local tumour control defined as time from inclusion to local radiological progression Definition of progression is based on response evaluation criteria in solid tumours RECIST 11
Secondary endpoints
Toxicity according to the Common Toxicity Criteria for Adverse Events CTCAE V50 grading system
Progression-free survival defined as time from inclusion until radiological progression Definition of progression is based on RECIST 11
Overall survival defined as time from inclusion until death from any cause
Quality of life QoL assessed by means of the EuroQol EQ-5D-5L measure of health outcome in general population and the European Organisation for Research and Treatment of Cancer EORTC QLQ-C30 QoL specific for patients with cancer with the supplementary module EORTC QLQ-BIL21 specific for CCA and gallbladder cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None