Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT03474094
Status:
UNKNOWN
Last Update Posted:
2023-01-27
First Post:
2018-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Biological Activity of an Anti-PD-L1 (Atezolizumab) in Operable Localised Soft Tissue Sarcomas Patients to be Treated With Radiotherapy
Sponsor:
Centre Leon Berard
Organization:
Study Overview
Official Title:
A European, Multicenter, Randomized, Open-label, Phase II Trial Aiming to Assess the Clinical and Biological Activity of an Anti-PD-L1 (Atezolizumab) in Operable Localised Soft Tissue Sarcomas Patients to be Treated With Radiotherapy
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
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:
RT-Immune
Brief Summary:
This multicentric, randomised, Phase II trial will use a pick-the-winner design in order to evaluate the clinical and biological activity of atezolizumab when combined with pre-operative or post-operative radiotherapy in STS patients.
Following Inform Consent Form (ICF) signature, eligible patients will be randomised (1:1:1) to receive:
* Arm A: Radiotherapy followed by atezolizumab then surgery.
* Arm B: Atezolizumab followed by surgery then radiotherapy.
* Arm C: Radiotherapy then surgery followed by atezolizumab.
The sequence of the study treatments is different among the 3 study arms. However, the dose regimens will be the same:
* Atezolizumab will be administered to all patients at the dose of 1200mg, by IV injection, for 2 cycles (Q3W).
* Radiotherapy will be administered to all patients at the dose of 2Gy/day, 5 days per week, for a total of 5 weeks and 50Gy.
* Surgery will be performed as per institutional practice.
Randomisation will be stratified according to histological subtypes as follows:
Group 1: Liposarcoma (LPS), Undifferentiated Pleomorphic Sarcoma (UPS), Leiomyosarcoma (LMS), myxofibrosarcoma, angiosarcoma versus Group 2: all translocation sarcoma except Ewing, rhabdomyosarcoma (RMS) and myxoid LPS.
Following Inform Consent Form (ICF) signature, eligible patients will be randomised (1:1:1) to receive:
* Arm A: Radiotherapy followed by atezolizumab then surgery.
* Arm B: Atezolizumab followed by surgery then radiotherapy.
* Arm C: Radiotherapy then surgery followed by atezolizumab.
The sequence of the study treatments is different among the 3 study arms. However, the dose regimens will be the same:
* Atezolizumab will be administered to all patients at the dose of 1200mg, by IV injection, for 2 cycles (Q3W).
* Radiotherapy will be administered to all patients at the dose of 2Gy/day, 5 days per week, for a total of 5 weeks and 50Gy.
* Surgery will be performed as per institutional practice.
Randomisation will be stratified according to histological subtypes as follows:
Group 1: Liposarcoma (LPS), Undifferentiated Pleomorphic Sarcoma (UPS), Leiomyosarcoma (LMS), myxofibrosarcoma, angiosarcoma versus Group 2: all translocation sarcoma except Ewing, rhabdomyosarcoma (RMS) and myxoid LPS.
Detailed Description:
This trial is a European, multicenter, open-label, randomized, Phase II trial using a pick-the-winner design aiming to the clinical and biological activity of anti-PD-L1 (atezolizumab) in a population of operable localised soft tissue sarcomas (STS) patients to be treated with radiotherapy.
Following inform consent signature and validation of eligibility criteria, patients will be randomized (1:1:1) into one of the 3 study arms:
* Arm A: Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery
* Arm B: 2 cycles of atezolizumab followed by surgery then post-operative radiotherapy
* Arm C: Pre-operative radiotherapy followed by surgery then 2 cycles of atezolizumab.
The sequence of treatment is different between the study arms, but the regimen of study treatments are the same. All randomized patients will received:
* The conventionally fractionated radiotherapy regimen of 2 Gy, 5 days a week up to a total dose of 50 Gy over 5 weeks. Radiotherapy will be either pre-(Arms A and C) or post-(Arm B) operative.
* Two cycles of atezolizumab (1200mg, IV, Q3W)
* Surgery will be performed as per institutional practice.
Randomisation will be stratified according to histological subtypes as follows
* Group 1: Leiomyosarcoma \[LMS\], Undifferentiated Pleomorphic Sarcoma \[UPS\], Liposarcoma \[LPS\], myxofibrosarcoma, angiosarcoma versus
* Group 2: all translocation sarcoma except Ewing, rhabdomyosarcoma RMS and myxoid LPS.
Following this sequence of treatment, all patients will be followed-up 2 weeks after the end of the treatment period then W18, W24 (=M6) then every 3 months until disease relapse, death, loss to follow-up. The minimal follow-up will be 1 year for the last randomized patient.
During the study period, the following tumor samples will be also collected for all randomized patients:
* A de novo tumor biopsy before study treatment start (pre-treatment tumor sample)
* A fragment of the surgery specimen.
Following inform consent signature and validation of eligibility criteria, patients will be randomized (1:1:1) into one of the 3 study arms:
* Arm A: Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery
* Arm B: 2 cycles of atezolizumab followed by surgery then post-operative radiotherapy
* Arm C: Pre-operative radiotherapy followed by surgery then 2 cycles of atezolizumab.
The sequence of treatment is different between the study arms, but the regimen of study treatments are the same. All randomized patients will received:
* The conventionally fractionated radiotherapy regimen of 2 Gy, 5 days a week up to a total dose of 50 Gy over 5 weeks. Radiotherapy will be either pre-(Arms A and C) or post-(Arm B) operative.
* Two cycles of atezolizumab (1200mg, IV, Q3W)
* Surgery will be performed as per institutional practice.
Randomisation will be stratified according to histological subtypes as follows
* Group 1: Leiomyosarcoma \[LMS\], Undifferentiated Pleomorphic Sarcoma \[UPS\], Liposarcoma \[LPS\], myxofibrosarcoma, angiosarcoma versus
* Group 2: all translocation sarcoma except Ewing, rhabdomyosarcoma RMS and myxoid LPS.
Following this sequence of treatment, all patients will be followed-up 2 weeks after the end of the treatment period then W18, W24 (=M6) then every 3 months until disease relapse, death, loss to follow-up. The minimal follow-up will be 1 year for the last randomized patient.
During the study period, the following tumor samples will be also collected for all randomized patients:
* A de novo tumor biopsy before study treatment start (pre-treatment tumor sample)
* A fragment of the surgery specimen.
Study Oversight
Has Oversight DMC:
True
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?: