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Could extra chemo stop sarcoma from spreading?

NCT ID NCT04307277

Disease control Sponsor: Institut Claudius Regaud Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This Phase 3 trial is testing whether adding four cycles of chemotherapy (doxorubicin-based) to standard surgery and radiation can improve outcomes for people with high-risk soft tissue sarcoma. The study will enroll 600 participants, with 250 high-risk patients randomly assigned to receive either standard care alone or standard care plus chemotherapy. The main goal is to see if the extra chemo helps prevent the cancer from spreading to other parts of the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Doxorubicin with Ifosfamide or Dacarbazine (chemotherapy)
What this could lead to
If it works, this could provide a new standard treatment option to delay or prevent cancer spread in high-risk soft tissue sarcoma patients.
What could go wrong
This is a Phase 3 trial, but results are not yet known. Chemotherapy has significant side effects, and the benefit may be small or not apply to all sarcoma types.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network 2. According to FNCLCC grading system, grade 1, 2 or 3 tumors 3. Resectable and localized disease after appropriate extension work-up (including at least a chest-CT) 4. 6 weeks or less between surgical excision and inclusion (if performed before inclusion) 5. Available archived FFPE tumor sample in sufficient quantity to allow CINSARC qualification 6. Age ≥ 18 years 7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 8. Life expectancy of at least 12 weeks after the start of the treatment 9. Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period and at least 12 months (ifosfamide treatment) or 6 months and 10 days (dacarbazine treatment) after the end of the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to registration. Men should accept to use an effective contraception during treatment period and at least 3 months and 10 days after the end of the study treatment. 10. Signed written informed consent 11. Patient affiliated to a Social Health Insurance in France. Exclusion Criteria: 1. Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcomas, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, epithelioid sarcoma, alveolar or embryonal rhabdomyosarcoma 2. Primitive cutaneous, retroperitoneal, uterus or visceral STS 3. Metastatic disease 4. Previous or ongoing treatment for the sarcoma (with the exception of surgical excision) 5. Contra-indication for Doxorubicin, Ifosfamide and Dacarbazine treatments 6. Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards, and prior therapy with anthracyclines 7. Prior mediastinal/cardiac radiotherapy 8. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia, myocardial infarction within 6 months prior to study entry 9. 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 10. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy 11. Known infection with HIV, hepatitis B, or hepatitis C 12. Women who are breastfeeding, pregnant or who plan to become pregnant while in the trial 13. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study 14. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice) 15. Patient unable to comply with the protocol for any reason. ADDITIONAL CRITERIA FOR THE RANDOMIZED PHASE III STUDY 1. High-risk CINSARC signature 2. Acceptable hematologic function (within 72 hours prior randomization): Absolute neutrophil count (ANC) ≥ 1.5 G/L, Platelet count ≥ 100 G/L and Hemoglobin \> 9g/dL 3. Acceptable renal function within 72 hours prior randomization: Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min (by the Cockcroft and Gault formula) 4. Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN 5. Normal LVEF (\>50%) measured by echocardiography or isotopic ventriculography

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Conditions

The condition(s) this trial relates to.

sarcoma soft tissue sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Soft tissue sarcoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHRU Besançon

    RECRUITING

    Besançon, France

  • CHU Limoges

    RECRUITING

    Limoges, France

  • CHU Marseille

    RECRUITING

    Marseille, France

  • CHU Poitiers

    RECRUITING

    Poitiers, France

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, 06189, France

  • Centre Eugène Marquis

    RECRUITING

    Rennes, 35042, France

  • Centre François Baclesse

    RECRUITING

    Caen, France

  • Centre Georges-François Leclerc

    RECRUITING

    Dijon, France

  • Centre Henri Becquerel

    RECRUITING

    Rouen, 76038, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, France

  • Hôpital Cochin

    RECRUITING

    Paris, France

  • Hôpitaux Universitaires de Strasbourg

    RECRUITING

    Strasbourg, France

  • Institut Godinot

    RECRUITING

    Reims, France

  • Institut Paoli-Calmettes

    RECRUITING

    Marseille, 13273, France

  • Institut Universitaire du Cancer Toulouse Oncopole

    RECRUITING

    Toulouse, France

  • Institut de Cancérologie de Lorraine - Centre Alexis Vautrin

    RECRUITING

    Vandœuvre-lès-Nancy, France

  • Institut de Cancérologie de Montpellier

    RECRUITING

    Montpellier, France

  • Institut de Cancérologie de l'Ouest

    RECRUITING

    Saint-Herblain, France

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