Could more chemo stop sarcoma spread? new trial aims to find out
NCT ID NCT03805022
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial is testing whether adding three extra cycles of chemotherapy before surgery can help prevent cancer spread in people with high-risk soft-tissue sarcoma. About 351 participants will be randomly assigned to standard treatment or standard treatment plus extra chemo. The main goal is to see if the extra chemo improves how long people live without the cancer spreading.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Doxorubicin, ifosfamide, or dacarbazine (chemotherapy drugs)
- What this could lead to
- If successful, this could lead to a more effective chemotherapy regimen that delays or prevents cancer spread in high-risk soft-tissue sarcoma patients.
- What could go wrong
- This is an early Phase 3 trial, so results are not yet proven. Chemotherapy has significant side effects, and the extra cycles may not improve outcomes or could cause more harm.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 351 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2019
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria : 1. Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network, as recommended by the French NCI, 2. Grade 2 or 3 according to the FNCLCC grading system, 3. Available archived tumour sample for research purpose, 4. Non-metastatic and resectable disease, 5. No prior treatment for the disease under study, 6. Age ≥ 18 years, 7. Life expectancy ≥ 3 months, 8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1, 9. Patients must have measurable disease (lesion in previously irradiated field can be considered as measurable if progressive at inclusion according to RECIST 1.1) defined as per RECIST v1.1 with at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm or ≥ 15mm in case of adenopathy, 10. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for one year after discontinuation of treatment. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier. Subjects of childbearing potential are those who have not been surgically sterilized (e.g., vasectomy for males and hysterectomy for females) or have not been free from menses for ≥ 1 year, 11. Voluntarily signed and dated written informed consents prior to any study specific procedure, 12. Patients with a social security in compliance with the French law. Exclusion Criteria : 1. Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clearcell sarcoma, embryonal and alveolar rhabdomyosarcoma, 2. Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma, 3. Any other contraindication to anthracycline, ifosfamide or dacarbazine chemotherapy, 4. Participation to a study involving a medical or therapeutic intervention in the last 28 days, 5. Known infection with HIV, hepatitis B, or hepatitis C, 6. Females who are pregnant or breast-feeding, 7. Other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study, 8. Individuals deprived of liberty or placed under legal guardianship, 9. Unwillingness or inability to comply with the study protocol for any reason. Additional criteria for randomization : 1. High-risk CINSARC signature, 2. No more than two cycle of neo-adjuvant anthracycline-based chemotherapy before randomization.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHRU Strasbourg
RECRUITINGStrasbourg, 67200, France
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CHU Dupuytren
RECRUITINGLimoges, 87042, France
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Centre Georges François Leclerc
RECRUITINGDijon, 21079, France
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Centre Léon Bérard
RECRUITINGLyon, 69373, France
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Insitut du Cancer
RECRUITINGMontpellier, 34298, France
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Institut Bergonie
RECRUITINGBordeaux, 33076, France
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Institut Claudius Regaud
RECRUITINGToulouse, 31052, France
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Institut Gustave Roussy
NOT_YET_RECRUITINGVillejuif, 94800, France
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Institut Paoli Calmettes
RECRUITINGMarseille, 13273, France
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Institut de Cancérologie de l'Ouest - Site René Gauducheau
RECRUITINGSaint-Herblain, 44805, France
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