Share
Save
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
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.
Study details:
Standard arm:. * Large en-bloc curative-intent surgery within 4 weeks following randomization- Experimental arm. 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-01-20
Primary completion: 2027-04-21
Study completion finish: 2028-04-21
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT04031677
Intervention or treatment
PROCEDURE: Surgery
DRUG: Preoperative chemotherapy
Conditions
- • Retroperitoneal Sarcoma
- • Liposarcoma
- • Leiomyosarcoma
Find a site
Closest Location:
Princess Alexandra Hospital - University Of Queensland
Research sites nearby
Select from list below to view details:
Princess Alexandra Hospital - University Of Queensland
Woolloongabba, Queensland, Australia
Peter Maccallum Cancer Institute
Melbourne, Victoria, Australia
Chris O'Brian Life House - Chris O'Brien Lifehouse
Camperdown, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
OTHER: Standard arm
| PROCEDURE: Surgery
|
EXPERIMENTAL: Experimental arm
| DRUG: Preoperative chemotherapy
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Disease free survival | Disease free survival will be measured from the date of randomization (as reference) to the date of recurrence or death, whichever occurs first. | 7 years from first patient in |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Overall survival (OS) | OS will be measured from the date of randomization to the date of death, whatever the cause. Alive patients will be censored at the date of last follow-up. | 8 years from first patient in |
Recurrence free survival | Recurrence free survival will be measured in patients who were successfully operated (R0/R1 resection) from the date of surgery (as reference) to the date of recurrence (local or distant) or death, whichever occurs first. Patients without one of these events will be censored at the date of last follow-up. | 8 years from first patient in |
Distant metastases free survival | Distant metastases free survival will be from the date of randomization (as reference) to the date of distant metastases or death (whatever the cause), whichever occurs first. Patients without any of these events will be censored at the date of last follow-up. | 8 years from first patient in |
Cumulative incidence of local recurrences | Cumulative incidence of local recurrences will be measured from the date of randomization (as reference) to the date of local recurrence. | 8 years from first patient in |
Cumulative incidence of distant metastases | Cumulative incidence of distant metastases will be measured from the date of randomization to the date of occurrence of distant metastases. | 8 years from first patient in |
Radiological response to neoadjuvant chemotherapy according to RECIST | For patients receiving neo-adjuvant chemotherapy, the radiological response will be assessed using RECIST 1.1 by comparison of the baseline and preoperative imaging. | 8 years from first patient in |
Radiological response to neoadjuvant chemotherapy according to CHOI | For patients receiving neo-adjuvant chemotherapy, the radiological response will be also assessed using Choi criteria by comparison of the baseline and preoperative imaging. | 8 years from first patient in |
Pathological response | Response evaluation will be done according to the EORTC response score. | 8 years from first patient in |
Safety and toxicity of neoadjuvant chemotherapy | Safety and toxicity of neoadjuvant chemotherapy will be evaluated and graded using CTCAE V5.0. | 8 years from first patient in |
Perioperative complications | Perioperative complications will be evaluated with the Dindo scale for the events related to the surgery and CTCAE V5.0 will be used for all other events. | 8 years from first patient in |
Late complications | Late complications (after the 60th day following the surgery) will be evaluated and graded according to the CTCAE version 5.0. | 8 years from first patient in |
Health-Related Quality of life (EORTC QLQ-C30 + Item list from QLQ-STO22) | Health-Related Quality of life assessment will be based on the EORTC QLQ C30 questionnaire version 3.0, with additional questions from the QLQ-STO22 module. | 8 years from first patient in |
Health utility, calculated from the collected patient-reported HRQoL data and patient demographics economics. | he EORTC QLQ C30 data will be mapped to health utility values using an established indirect mapping approach. | 8 years from first patient in |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!