Surgery With Our Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma (STRASS2)
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|ClinicalTrials.gov Identifier: NCT04031677|
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : July 20, 2021
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.
After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
|Condition or disease||Intervention/treatment||Phase|
|Retroperitoneal Sarcoma Liposarcoma Leiomyosarcoma||Procedure: Surgery Drug: Preoperative chemotherapy||Phase 3|
- Large en-bloc curative-intent surgery within 4 weeks following randomization- Experimental arm
3 cycles of neoadjuvant chemotherapy starting within 2 weeks following randomization:
- High grade LPS: ADM (doxorubicin) 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m3 Q3 weeks.
- LMS: ADM 75 mg/m2 + DTIC (dacarbazine) 1 g/m2 Q3 weeks
- re-assessment of operability
- curative-intent surgery within 3-6 weeks of last cycle of chemotherapy
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)|
|Actual Study Start Date :||October 6, 2020|
|Estimated Primary Completion Date :||April 21, 2027|
|Estimated Study Completion Date :||April 21, 2028|
Large en-bloc curative-intent surgery
Experimental: Experimental arm
Preoperative chemotherapy and surgery
Drug: Preoperative chemotherapy
- High grade LPS: ADM 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m2 Q3 weeks
Note: the recommended dose of Ifosfamide can be modified according to national/institutional guidelines, given that the minimum threshold must be 7.5 g/m2 per cycle.
- LMS: ADM 75 mg/m2 + DTIC 1g/m2 Q3 weeks
Other Name: neoadjuvant chemotherapy
- Disease free survival [ Time Frame: 7 years from first patient in ]Disease free survival will be measured from the data of randomization (as reference) to the date of recurrence or death, whichever occurs first.
- Overall survival (OS) [ Time Frame: 8 years from first patient in ]OS will be measured from the date of randomization to the date of death, whatever the cause.
- Local recurrence free survival [ Time Frame: 8 years from first patient in ]Local recurrence free survival will be measured from the date of randomization to the date of recurrence (local) or death, whichever occurs first.
- Recurrence free survival [ Time Frame: 8 years from first patient in ]Recurrence free survival will be measured from the date of randomization to the date of recurrence (local or distant) or death, whichever occurs first.
- Distant metastases free survival [ Time Frame: 8 years from first patient in ]Distant metastases free survival will be measured from the date of randomization to the date of distant metastases or death, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031677
|Contact: EORTC HQemail@example.com|
|Study Chair:||Alessandro Gronchi||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|
|Study Chair:||Winan van Houdt||The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis|