Non-metastatic Soft-tissue SarcomaPhase 3CIRSARCNCT03805022
Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas
A Phase 3 study testing Doxorubicin, Ifosfamide or dacarbazine and At the discretion of the investigator in people with Non-metastatic Soft-tissue Sarcoma and Resectable, run by Institut Bergonié at 10 sites in France.
Trial summary
The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-metastatic Soft-tissue Sarcoma, Resectable
- What is being tested?
- Doxorubicin, Ifosfamide or dacarbazine and At the discretion of the investigator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 10 sitesFrance
- Study dates
- 14 Feb 2019to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
- Grade 2 or 3 according to the FNCLCC grading system,
- Available archived tumour sample for research purpose,
- Non-metastatic and resectable disease,
- No prior treatment for the disease under study,
- Age ≥ 18 years,
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- Life expectancy ≥ 3 months,
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
- 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,
- 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,
- Voluntarily signed and dated written informed consents prior to any study specific procedure,
- Patients with a social security in compliance with the French law.
Who cannot join
- Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clearcell sarcoma, embryonal and alveolar rhabdomyosarcoma,
- 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,
- Any other contraindication to anthracycline, ifosfamide or dacarbazine chemotherapy,
- Participation to a study involving a medical or therapeutic intervention in the last 28 days,
- Known infection with HIV, hepatitis B, or hepatitis C,
- Females who are pregnant or breast-feeding,
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- 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,
- Individuals deprived of liberty or placed under legal guardianship,
- Unwillingness or inability to comply with the study protocol for any reason.
- Additional criteria for randomization :
- High-risk CINSARC signature,
- No more than two cycle of neo-adjuvant anthracycline-based chemotherapy before randomization.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Simone MATHOULIN-PELISSIER, MD, PhD contact
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
Institut Bergonie
Bordeaux, 33076
Antoine ITALIANO, MD, PhD, a.italiano@bordeaux.unicancer.fr
Antoine ITALIANO
- Recruiting
Centre Georges François Leclerc
Dijon, 21079
Nicolas ISAMBERT
Nicolas ISAMBERT, MD
- Recruiting
CHU Dupuytren
Limoges, 87042
Valérie LEBRUN-LY, MD
Valérie LEBRUN-LY, MD
- Recruiting
Centre Léon Bérard
Lyon, 69373
Jean-Yves BLAY, MD, PhD
Jean-Yves BLAY, MD, PhD
- Recruiting
Institut Paoli Calmettes
Marseille, 13273
François BERTUCCI, MD, PhD
François BERTUCCI, MD, PhD
- Recruiting
Insitut du Cancer
Montpellier, 34298
Nelly FIRMIN, MD, nelly.firmin@icm.unicancer.fr
Nelly FIRMIN, MD
- Recruiting
Institut de Cancérologie de l'Ouest - Site René Gauducheau
Saint-Herblain, 44805
Emmanuelle BOMPAS, MD
Emmanuelle BOMPAS, MD
- Recruiting
CHRU Strasbourg
Strasbourg, 67200
Jean-Emmanuel KURTZ, MD, PhD, je.kurtz@icans.eu
- Recruiting
Institut Claudius Regaud
Toulouse, 31052
Christine CHEVREAU, chevreau.christine@iuct-oncopole.fr
Christine CHEVREAU
- Not yet recruiting
Institut Gustave Roussy
Villejuif, 94800
Axel LE CESNE, MD
Axel LE CESNE, MD
About this study
Official title: Phase III Trial Investigating the Potential Benefit of Intensified Peri-operative Chemotherapy With in High-risk CINSARC Patients With Resectable Soft-tissue SARComas
The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).
Read the detailed description
For high-risk CINSARC patients, this is a multicenter randomized two-arm phase III trial, with a ratio 1:1:
- Arm A: standard management (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy)
- Arm B: experimental arm (6 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy)
For low-risk CINSARC patients, this a multicenter prospective cohort with treatment at the discretion of the investigator.
- Conditions
- Non-metastatic Soft-tissue Sarcoma, Resectable
- Being tested
- Doxorubicin, Ifosfamide or dacarbazine, At the discretion of the investigator
- Keywords
- Solid tumor, Phase III trial, Soft-tissue sarcoma, Resectable, Non-metastatic
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
A treatment cycle consists of 3 weeks. Doxorubicin will be administered from day 1 to day 3 (60 or 75mg/m² day or 20 or 25 mg/m² per day), repeated every 3 weeks, up to 3 cycles.
Ifosfamide or dacarbazineDrug
A treatment cycle consists of 3 weeks. Treatment may continue up to 3 cycles. Ifosfamide will be administered from day 1 to day 3 (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices, repeated every 3 weeks, up to 3 cycles.
DoxorubicinDrug
A treatment cycle consists of 3 weeks. Doxorubicin will be administered from day 1 to day 3 (60 or 75mg/m² day or 20 or 25 mg/m² per day), repeated every 3 weeks, up to 6 cycles.
Ifosfamide or dacarbazineDrug
A treatment cycle consists of 3 weeks. Ifosfamide will be administered from day 1 to day 3 (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices, repeated every 3 weeks, up to 6 cycles.
At the discretion of the investigatorDrug
Drug at the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Control-Arm phase III high-risk CINSARC:
Patients will be treated by doxorubicin (60 or 75mg/m² day or 20- or 25 mg/m² per day from day1 to day 3) + ifosfamide (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices of a 21-days cycle for up to 3 cycles in neoadjuvant setting Neoadjuvant chemotherapy will be followed by surgery. If indicated, radiotherapy could be prescribed at the discretion of the investigator (in neoadjuvant or adjuvant setting). Receives: Drug: Doxorubicin; Drug: Ifosfamide or dacarbazine |
| Arm B | Experimental | Experimental-Arm phase III high-risk CINSARC:
Patients will be treated by doxorubicin (60 or 75mg/m² day or 20 or 25 mg/m² per day from day1 to day 3) + ifosfamide (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices of a 21-days cycle for up to 6 cycles in neoadjuvant setting Neoadjuvant chemotherapy will be followed by surgery. If indicated, radiotherapy could be prescribed at the discretion of the investigator (in neoadjuvant or adjuvant setting). Receives: Drug: Doxorubicin; Drug: Ifosfamide or dacarbazine |
| Prospective cohort | Experimental | Patients will be treated at the discretion of the investigator Receives: Drug: At the discretion of the investigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastasis progression-free survival in High-risk CINSARC patients
Metastasis progression-free survival (M-PFS) defined as the time interval between the date of randomization and the date of death or distant progression.
Measured: 3 years
Secondary outcomes (10)
Loco-regional relapse-free survival in High-risk CINSARC patients
Loco-regional relapse-free survival (LR-RFS) defined as the time interval between the randomization date and the date of death or loco-regional progression.
Measured: 3 years
Progression-free survival in High-risk CINSARC patients
Progression-free survival (PFS) defined as the time interval between the randomization date and the date of death or progression (as per RECIST v1.1).
Measured: 3 years
Overall survival in High-risk CINSARC patients
Overall survival (OS) defined as the time interval between the randomization date and the date of death.
Measured: 3 years
Best overall response in High-risk CINSARC patients
Best overall response under treatment as per RECIST v1.1.
Measured: Throughout the treatment period, an average of 6 months
Histological response in High-risk CINSARC patients
Histological response defined as the proportion of recognizable cells on the tumor sample.
Measured: An average of 6 months
Safety profile in High-risk CINSARC patients
Toxicity graded using the common toxicity criteria from the NCI v5.
Measured: Throughout the treatment period, an average of 6 months
Progression-free survival in Low-risk CINSARC patients
Progression-free survival defined as the time interval between the randomization date and the date of death or progression (as per RECIST v1.1).
Measured: 3 years
Metastasis progression-free survival in Low-risk CINSARC patients
Metastasis progression-free survival defined as the time interval between the inclusion date and the date of death or distant progression.
Measured: 3 years
Loco-regional progression-free survival in Low-risk CINSARC patients
Description of the treatment efficacy in terms of 3-years loco-regional progression-free survival defined as the time interval between the randomization date and the date of death or loco-regional progression.
Measured: 3 years
Overall survival in Low-risk CINSARC patients
Overall survival defined as the time interval between the inclusion date and the date of death.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start14 Feb 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-metastatic Soft-tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter trial with: * An open randomized two-arm phase III trial for high-risk CINSARC patients assessing whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management (3 cycles of neoadjuvant anthracycline based chemotherapy + surgery +/- radiotherapy) improves the outcome of patients * a prospective cohort for low-risk CINSARC patients.
- Masking
- None (open label)
- Enrolment
- 351 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Chugai Pharma France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805022
- Sponsor's protocol ID
- IB 2017-04
- Other IDs
- 2018-000186-36, 2018
- Acronym
- CIRSARC
- Status last verified
- Oct 2025
- First submitted
- 10 Jan 2019
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial Investigating the Potential Benefit of Intensified Peri-operative Chemotherapy With in High-risk CINSARC Patients With Resectable Soft-tissue SARComas
- ClinicalTrials.gov ID
- NCT03805022
- Acronym / sponsor ID
- CIRSARC / IB 2017-04
- Conditions
- Non-metastatic Soft-tissue Sarcoma, Resectable
- Keywords
- Solid tumor, Phase III trial, Soft-tissue sarcoma, Resectable, Non-metastatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 351 participants (estimated)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Novartis, Chugai Pharma France
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).
Detailed description
For high-risk CINSARC patients, this is a multicenter randomized two-arm phase III trial, with a ratio 1:1:
- Arm A: standard management (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy)
- Arm B: experimental arm (6 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy)
For low-risk CINSARC patients, this a multicenter prospective cohort with treatment at the discretion of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a multicenter trial with: * An open randomized two-arm phase III trial for high-risk CINSARC patients assessing whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management (3 cycles of neoadjuvant anthracycline based chemotherapy + surgery +/- radiotherapy) improves the outcome of patients * a prospective cohort for low-risk CINSARC patients.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Doxorubicin, Drug: Ifosfamide or dacarbazineControl-Arm phase III high-risk CINSARC: Patients will be treated by doxorubicin (60 or 75mg/m² day or 20- or 25 mg/m² per day from day1 to day 3) + ifosfamide (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices of a 21-days cycle for up to 3 cycles in neoadjuvant setting Neoadjuvant chemotherapy will be followed by surgery. If indicated, radiotherapy could be prescribed at the discretion of the investigator (in neoadjuvant or adjuvant setting). |
| Arm B | Experimental | Drug: Doxorubicin, Drug: Ifosfamide or dacarbazineExperimental-Arm phase III high-risk CINSARC: Patients will be treated by doxorubicin (60 or 75mg/m² day or 20 or 25 mg/m² per day from day1 to day 3) + ifosfamide (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices of a 21-days cycle for up to 6 cycles in neoadjuvant setting Neoadjuvant chemotherapy will be followed by surgery. If indicated, radiotherapy could be prescribed at the discretion of the investigator (in neoadjuvant or adjuvant setting). |
| Prospective cohort | Experimental | Drug: At the discretion of the investigatorPatients will be treated at the discretion of the investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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,
- Grade 2 or 3 according to the FNCLCC grading system,
- Available archived tumour sample for research purpose,
- Non-metastatic and resectable disease,
- No prior treatment for the disease under study,
Key exclusion criteria (12 listed)
- Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clearcell sarcoma, embryonal and alveolar rhabdomyosarcoma,
- 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,
- Any other contraindication to anthracycline, ifosfamide or dacarbazine chemotherapy,
- Participation to a study involving a medical or therapeutic intervention in the last 28 days,
- Known infection with HIV, hepatitis B, or hepatitis C,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxorubicinA treatment cycle consists of 3 weeks. Doxorubicin will be administered from day 1 to day 3 (60 or 75mg/m² day or 20 or 25 mg/m² per day), repeated every 3 weeks, up to 3 cycles. | Drug | Arm A |
| Ifosfamide or dacarbazineA treatment cycle consists of 3 weeks. Treatment may continue up to 3 cycles. Ifosfamide will be administered from day 1 to day 3 (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices, repeated every 3 weeks, up to 3 cycles. | Drug | Arm A |
| DoxorubicinA treatment cycle consists of 3 weeks. Doxorubicin will be administered from day 1 to day 3 (60 or 75mg/m² day or 20 or 25 mg/m² per day), repeated every 3 weeks, up to 6 cycles. | Drug | Arm B |
| Ifosfamide or dacarbazineA treatment cycle consists of 3 weeks. Ifosfamide will be administered from day 1 to day 3 (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices, repeated every 3 weeks, up to 6 cycles. | Drug | Arm B |
| At the discretion of the investigatorDrug at the discretion of the investigator. | Drug | Prospective cohort |
Primary outcome
Metastasis progression-free survival in High-risk CINSARC patients
Time frame: 3 years
Metastasis progression-free survival (M-PFS) defined as the time interval between the date of randomization and the date of death or distant progression.
10 secondary outcomes
Loco-regional relapse-free survival in High-risk CINSARC patients
Time frame: 3 years
Progression-free survival in High-risk CINSARC patients
Time frame: 3 years
Overall survival in High-risk CINSARC patients
Time frame: 3 years
Best overall response in High-risk CINSARC patients
Time frame: Throughout the treatment period, an average of 6 months
Histological response in High-risk CINSARC patients
Time frame: An average of 6 months
Safety profile in High-risk CINSARC patients
Time frame: Throughout the treatment period, an average of 6 months
Progression-free survival in Low-risk CINSARC patients
Time frame: 3 years
Metastasis progression-free survival in Low-risk CINSARC patients
Time frame: 3 years
Loco-regional progression-free survival in Low-risk CINSARC patients
Time frame: 3 years
Overall survival in Low-risk CINSARC patients
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simone MATHOULIN-PELISSIER, MD, PhD contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxorubicin, Ifosfamide or dacarbazine and At the discretion of the investigator in people with Non-metastatic Soft-tissue Sarcoma and Resectable, run by Institut Bergonié at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine ITALIANO, MD, PhD (+33 5.56.33.33.33, a.italiano@bordeaux.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastasis progression-free survival in High-risk CINSARC patients (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.