The PET- Retroperitoneal Sarcoma Study (NCT04224948) | Clinical Trial Compass
CompletedNot Applicable
The PET- Retroperitoneal Sarcoma Study
Canada18 participantsStarted 2020-01-03
Plain-language summary
Retroperitoneal sarcoma(RPS) is a rare cancer that is difficult to cure as it typically presents as a very large abdominal mass, and complete removal with clear margins is challenging . This study will focus on improving the outcomes of surgery by treating RPS before surgery, to make resection more effective. The role of chemotherapy as a preoperative treatment for RPS is highly controversial. Response to chemotherapy is unpredictable and if the patient's tumour progresses instead of responding, the window of opportunity for resection will be lost. Conventional cross sectional imaging (CT scan) is inadequate to measure response to chemotherapy until 5-6 cycles have been given, possibly with no improvement. Thus it is critical to develop an earlier and reliable way to assess response. Functional imaging by PET scan is used in other tumour types to identify early response to treatment. PET imaging may provide a more meaningful assessment of RPS response to systemic therapy much earlier in the course of treatment than conventional imaging, allowing timely modification of the treatment plan. This study will define the role of PET imaging in evaluating early response to systemic therapy in high grade RPS, improving patient treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Tumour-related criteria
* Primary soft tissue sarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis
* Sarcoma not originated from bone structure, abdominal or gynecological viscera
* Unifocal tumour (not multifocal disease)
* Absence of extension through the sciatic notch or across the diaphragm
* Histologically-proven RPS (local pathologist/ imaging-guided or surgical biopsy), only including the following histological sub-types:
* High grade Leiomyosarcoma
* High grade Dedifferentiated Liposarcoma
* Tumour not previously treated (no previous surgery -excluding diagnosis biopsy-, radiotherapy or systemic therapy)
* Tumour both operable and suitable for chemotherapy (This will be based on pretreatment CT scan/MRI and multidisciplinary consultation with surgeon medical oncologist and radiologist (anticipated macroscopically complete resection, R0/R1resection)
* Patients for whom surgery is expected to be R2 on the CT-scan before randomization are not eligible
* Patients must have American Society of Anesthesiologist (ASA) score ≤ 2 (see Appendix G)
* The criteria for non-resectability are:
* (i) involvement of superior mesenteric artery
* (ii) involvement of aorta
* (iii) involvement of bone
* distant metastatic disease
* Patient must have radiologically measurable disease (RECIST 1.1)
Patient-related criteria
* ≥ 18 years' old
* WHO performance status ≤ 2 (see Appendix C)
* Absence of history of bowel obstruction or mesenteric ischemia …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation of PET imaging with histologic response following preoperative chemotherapy.