Soft Tissue SarcomaPhase 3CHIC-STS01NCT04307277
Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma
A Phase 3 study of Soft Tissue Sarcoma, run by Institut Claudius Regaud at 20 sites in France.
Trial summary
Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 20 sitesFrance
- Study dates
- 9 Oct 2020to Oct 2032
- 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
- Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network
- According to FNCLCC grading system, grade 1, 2 or 3 tumors
- Resectable and localized disease after appropriate extension work-up (including at least a chest-CT)
- 6 weeks or less between surgical excision and inclusion (if performed before inclusion)
- Available archived FFPE tumor sample in sufficient quantity to allow CINSARC qualification
- Age ≥ 18 years
Show all 11Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Life expectancy of at least 12 weeks after the start of the treatment
- 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.
- Signed written informed consent
- Patient affiliated to a Social Health Insurance in France.
Who cannot join
- 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
- Primitive cutaneous, retroperitoneal, uterus or visceral STS
- Metastatic disease
- Previous or ongoing treatment for the sarcoma (with the exception of surgical excision)
- Contra-indication for Doxorubicin, Ifosfamide and Dacarbazine treatments
- Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards, and prior therapy with anthracyclines
Show all 21Show fewer
- Prior mediastinal/cardiac radiotherapy
- 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
- 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
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Known infection with HIV, hepatitis B, or hepatitis C
- Women who are breastfeeding, pregnant or who plan to become pregnant while in the trial
- 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
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
- Patient unable to comply with the protocol for any reason.
- ADDITIONAL CRITERIA FOR THE RANDOMIZED PHASE III STUDY
- High-risk CINSARC signature
- 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
- 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)
- Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN
- Normal LVEF (>50%) measured by echocardiography or isotopic ventriculography
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 20 recruiting
- Recruiting
CHRU Besançon
Besançon
Loïc CHAIGNEAU, 03 81 47 99 99, lchaigneau@chu-besancon.fr
- Recruiting
Centre François Baclesse
Caen
Zoé NEVIERE, 02 31 45 50 11, z.neviere@baclesse.unicancer.fr
- Recruiting
Centre Jean Perrin
Clermont-Ferrand
Pascale DUBRAY-LONGERAS, 04 73 27 80 80, pascale.dubray-longeras@clermont.unicancer.fr
- Recruiting
Centre Georges-François Leclerc
Dijon
Alice HERVIEU, 03 80 73 75 06, ahervieu@cgfl.fr
- Recruiting
CHU Limoges
Limoges
Valérie LE BRUN-LY, 05 55 05 63 96, valerie.lebrun@chu-limoges.fr
- Recruiting
Centre Léon Bérard
Lyon
Armelle DUFRESNE, 04 69 85 61 46, armelle.dufresne@lyon.unicancer.fr
- Recruiting
Institut Paoli-Calmettes
Marseille, 13273
François BERTUCCI, 04 91 22 35 37, bertuccif@ipc.unicancer.fr
- Recruiting
CHU Marseille
Marseille
Florence DUFFAUD, 04 91 38 54 39, florence.duffaud@ap-hm.fr
- Recruiting
Institut de Cancérologie de Montpellier
Montpellier
Nelly FIRMIN, 04 67 61 45 65, nelly.firmin@icm.unicancer.fr
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
Esma SAADA-BOUZID, 04 92 03 15 14, esma.saada-bouzid@nice.unicancer.fr
- Recruiting
Hôpital Cochin
Paris
Pascaline BOUDOU-ROUQUETTE, 01 58 41 17 46, pascaline.boudou@aphp.fr
- Recruiting
CHU Poitiers
Poitiers
Nicolas ISAMBERT, 05 49 44 45 38, nicolas.isambert@chu-poitiers.fr
- Recruiting
Institut Godinot
Reims
Pauline SOIBINET-OUDOT, 03 26 50 43 83, pauline.soibinet@reims.unicancer.fr
- Recruiting
Centre Eugène Marquis
Rennes, 35042
Perrine VUAGNAT, 02 99 25 29 69, p.vuagnat@rennes.unicancer.fr
- Recruiting
Centre Henri Becquerel
Rouen, 76038
Cécile GUILLEMET, 02 32 08 22 37, cecile.guillemet@chb.unicancer.fr
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain
Emmanuelle BOMPAS, 02 40 67 99 39, emmanuelle.bompas@ico.unicancer.fr
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg
Justine GANTZER, MD, 03 68 76 72 25, justine.gantzer@chru-strasbourg.fr
- Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse
Thibaud VALENTIN, 05 31 15 51 70, valentin.thibaud@iuct-oncopole.fr
- Recruiting
Institut de Cancérologie de Lorraine - Centre Alexis Vautrin
Vandœuvre-lès-Nancy
Maria RIOS, 03 83 59 84 61, m.rios@nancy.unicancer.fr
- Recruiting
Institut Gustave Roussy
Villejuif, Île-de-France Region, 94800
Benjamin VERRET, MD, 0033 1 42 11 42 11, benjamin.verret@gustaveroussy.fr
About this study
Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature.
After signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened).
Read more
Patients considered as low-risk according to CINSARC signature will be treated at the discretion of the clinicians (prospective cohort).
Patients considered as high-risk according to CINSARC signature will be randomized in the open-label multicenter phase III trial and assigned in one of the two following treatments arms:
- Arm A (control arm): Standard of care (surgical excision +/- external radiotherapy).
- Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during 12 weeks.
A total of 250 patients will have to be randomized with 125 patients in each arm.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Standard of care + chemotherapy, Standard of care
- Keywords
- Soft Tissue Sarcoma, CINSARC signature, Chemotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care + chemotherapyDrug
Doxorubicine with Ifosfamide during 4 cycles Q3W Or Doxorubicine with Dacarbazine during 4 cycles Q3W (for patients with Leiomyosarcoma)
Standard of careOther
Surgical excision with external radiotherapy (if applicable)
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Other | Not described Receives: Other: Standard of care |
| Experimental arm | Experimental | Not described Receives: Drug: Standard of care + chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastasis-free survival defined by the delay between randomization and the appearance of metastatic.
Measured: 5 years for each patient
Secondary outcomes (3)
Disease-free survival defined by the delay between randomization and first relapse (local, regional, or distant) or death from any cause.
Measured: 5 years for each patient
Safety assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5.0).
Measured: 4 months for each patient
Overall survival defined by the delay between randomization and death from any cause.
Measured: 5 years for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start9 Oct 2020
- Primary completionOct 2032 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307277
- Sponsor's protocol ID
- 19SARC05
- Acronym
- CHIC-STS01
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Filleron T, Le Guellec S, Chevreau C, Cabarrou B, Lesluyes T, Lodin S, Massoubre A, Mounier M, Poublanc M, Chibon F, Valentin T. Value of peri-operative chemotherapy in patients with CINSARC high-risk localized grade 1 or 2 soft tissue sarcoma: study protocol of the target selection phase III CHIC-STS trial. BMC Cancer. 2020 Jul 31;20(1):716. doi: 10.1186/s12885-020-07207-3.
PubMed 32736540
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT04307277
- Acronym / sponsor ID
- CHIC-STS01 / 19SARC05
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Soft Tissue Sarcoma, CINSARC signature, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- Oct 2032 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 13 Mar 2020 (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.
Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature.
After signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened).
Patients considered as low-risk according to CINSARC signature will be treated at the discretion of the clinicians (prospective cohort).
Patients considered as high-risk according to CINSARC signature will be randomized in the open-label multicenter phase III trial and assigned in one of the two following treatments arms:
- Arm A (control arm): Standard of care (surgical excision +/- external radiotherapy).
- Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during 12 weeks.
A total of 250 patients will have to be randomized with 125 patients in each arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Other | Other: Standard of care |
| Experimental arm | Experimental | Drug: Standard of care + chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network
- According to FNCLCC grading system, grade 1, 2 or 3 tumors
- Resectable and localized disease after appropriate extension work-up (including at least a chest-CT)
- 6 weeks or less between surgical excision and inclusion (if performed before inclusion)
- Available archived FFPE tumor sample in sufficient quantity to allow CINSARC qualification
Key exclusion criteria (21 listed)
- 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
- Primitive cutaneous, retroperitoneal, uterus or visceral STS
- Metastatic disease
- Previous or ongoing treatment for the sarcoma (with the exception of surgical excision)
- Contra-indication for Doxorubicin, Ifosfamide and Dacarbazine treatments
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 |
|---|---|---|
| Standard of care + chemotherapyDoxorubicine with Ifosfamide during 4 cycles Q3W Or Doxorubicine with Dacarbazine during 4 cycles Q3W (for patients with Leiomyosarcoma) | Drug | Experimental arm |
| Standard of careSurgical excision with external radiotherapy (if applicable) | Other | Control arm |
Primary outcome
Metastasis-free survival defined by the delay between randomization and the appearance of metastatic.
Time frame: 5 years for each patient
3 secondary outcomes
Disease-free survival defined by the delay between randomization and first relapse (local, regional, or distant) or death from any cause.
Time frame: 5 years for each patient
Safety assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5.0).
Time frame: 4 months for each patient
Overall survival defined by the delay between randomization and death from any cause.
Time frame: 5 years for each patient
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 16 Oct 2026.
- Background: PubMed 32736540Filleron T, Le Guellec S, Chevreau C, Cabarrou B, Lesluyes T, Lodin S, Massoubre A, Mounier M, Poublanc M, Chibon F, Valentin T. Value of peri-operative chemotherapy in patients with CINSARC high-risk localized grade 1 or 2 soft tissue sarcoma: study protocol of the target selection phase III CHIC-STS trial. BMC Cancer. 2020 Jul 31;20(1):716. doi: 10.1186/s12885-020-07207-3.
Related trials for Soft Tissue Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Soft Tissue Sarcoma, run by Institut Claudius Regaud at 20 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 11 inclusion and 21 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 Thibaud VALENTIN (05 31 15 51 70, valentin.thibaud@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastasis-free survival defined by the delay between randomization and the appearance of metastatic. (time frame: 5 years for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04307277, which also lists 1 linked publication.
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 16 Oct 2026.