Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06502080
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-07
Brief Title:
Consolidative Radiotherapy CSRT in Patients With OligometastaticLocally Advanced Unresectable Bilary Tract Cancer BTC
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Standard-of-care Systemic Therapy With or Without Consolidative Radiotherapy in Patients With OligometastaticLocally Advanced Unresectable Biliary Tract Cancer an Open-label Randomised Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
RADITOP
Brief Summary:
The purpose of this clinical trial is to investigate whether the inclusion of radiotherapy in addition to standard-of-care systemic therapy could improve the treatment effectiveness of patients with oligometastaticlocally advanced unresectable biliary tract cancer The primary question that the trial aims to address is does the addition of consolidative radiotherapy to standard-of-care systemic therapy for treating oligometastaticlocally advanced unresectable biliary tract cancer result in a prolonged progression-free survival PFS
Researchers will assess whether radiotherapy can enhance PFS by comparing the survival time of patients with oligometastaticlocally advanced unresectable biliary tract cancer who receive standard-of-care systemic therapy alone versus those who receive standard-of-care systemic therapy along with consolidative radiotherapy
Participants in this trial will
Either receive or not receive consolidative radiotherapy following six cycles of standard-of-care systemic therapy
Researchers will assess whether radiotherapy can enhance PFS by comparing the survival time of patients with oligometastaticlocally advanced unresectable biliary tract cancer who receive standard-of-care systemic therapy alone versus those who receive standard-of-care systemic therapy along with consolidative radiotherapy
Participants in this trial will
Either receive or not receive consolidative radiotherapy following six cycles of standard-of-care systemic therapy
Detailed Description:
Standard-of-care systemic therapy with or without consolidative radiotherapy in patients with oligometastaticlocally advanced unresectable biliary tract cancer an open-label randomised controlled study
Eligible patients will be randomized in a 11 ratio to receive either current standard systemic therapy alone control arm or standard systemic therapy plus consolidative radiotherapy to all sites of known disease experimental arm Patients in both arms have the option of receiving upfront or subsequent standard palliative radiotherapy to any symptomatic sites requiring prompt intervention
Because of the different treatment modalities in the study it is not possible to blind the patient or physician to the treatment arm Follow-ups for tumor assessment will conclude 2 years after randomization
Eligible patients will be randomized in a 11 ratio to receive either current standard systemic therapy alone control arm or standard systemic therapy plus consolidative radiotherapy to all sites of known disease experimental arm Patients in both arms have the option of receiving upfront or subsequent standard palliative radiotherapy to any symptomatic sites requiring prompt intervention
Because of the different treatment modalities in the study it is not possible to blind the patient or physician to the treatment arm Follow-ups for tumor assessment will conclude 2 years after randomization
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZSLCYJ202308 | OTHER_GRANT | None | None |