Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT03474094
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.
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.
Study:
NCT03474094
Study Brief:
Protocol Section:
NCT03474094