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
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
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- 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
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- 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