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A sarcoma study - SR7

A study to test the effect of chemotherapy before surgery compared to surgery alone in patients with high risk retroperitoneal sarcoma
Disease Site
Sarcoma Clinical Trials
Trial Code
SR.7 | NCT04031677
Trial Status
Open to patient enrollment

What is the purpose of this study?

The purpose of this study is to compare the effects of receiving chemotherapy before surgery on you and your sarcoma compared to surgery alone.

Why is this study important?

Giving chemotherapy before surgery (called “neoadjuvant” chemotherapy) is a new approach to treating your kind of sarcoma. While the standard treatment for your cancer is surgery alone without chemotherapy, researchers think that neoadjuvant chemotherapy may improve the treatment of your cancer. However, it is not clear whether the addition of neoadjuvant chemotherapy can offer better results than the standard treatment.

Who can participate in this study?

This trial is for:

  • Patients with high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of the retroperitoneal space (in the abdominal cavity) or in the pelvis
  • Patients who have had no previous treatment for this disease
  • Patients 18 years of age or older

This trial is not for:

  • Patients whose disease has spread to other areas of the body
  • Patients who have had a heart attack within the previous 6 months
  • Patients who are pregnant or breastfeeding
What are the risks?
  • If you choose to take part in this study, there is a risk that adding neoadjuvant chemotherapy may not be as good as the standard treatment of surgery alone. There is also a risk that you could have side effects from the chemotherapy. Some of the most common side effects that the study doctors know about are infection, decreased appetite, hair loss and fatigue. You will find details of all side effects in the consent document that you review with your doctor.
What can I expect?
  • If you choose to take part in this study, you will be randomly placed in one of two groups and you will receive either neoadjuvant chemotherapy before your surgery or surgery alone, which is the current way of treating this disease.
  • You will also be asked to complete a questionnaire at different times, to understand your Quality of Life.

How can I find out more or join the study?

Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.

Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have.

Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.

The SR.7 study is currently enrolling patients at cancer centres in Canada. For a full list of participating cancer centres please visit www.clinicaltrials.gov and search using NCT04031677.

The direct link to the webpage is: https://www.clinicaltrials.gov/study/NCT04031677?cond=Sarcoma&term=EORTC%201809-STBSG&rank=1

Use this trial information for your conversation with your health care team

Participating centres
  • CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont - Montreal, QC, H1T 2M4 - Contact: Dr. Mai-Kim Gervais
  • The Research Institute of the McGill University Health Centre - Montreal, QC, H4A 3J1 - Contact: Dr. Ramy Saleh
  • Ottawa Hospital Research Institute - Ottawa, ON, K1H 8L6 - Contact: Dr. Carolyn Nessim
  • Sinai Health System - Toronto, ON, M5G 1X5 - Contact: Dr. Carol Jane Swallow
  • Verspeeten Family Cancer Centre - London, ON, N6A 5W9 - Contact: Dr. Allison Maciver
  • BCCA - Vancouver - Vancouver, BC, V5Z 4E6 - Contact: Dr. Christine Simmons