BridgeMD
New treatment option for Non-metastatic Soft-tissue Sarcoma
Official title Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas
ClinicalTrials.gov ID: NCT03805022
What this study is testing
What is Doxorubicin?
Doxorubicin is an investigational medicine, being studied as a potential treatment for non-metastatic soft-tissue sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network, as recommended by...
- 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,
You likely can't join if
- Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma...
- Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal...
- 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,
See the full eligibility criteria
- 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,
- 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...
- 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...
- Voluntarily signed and dated written informed consents prior to any study specific procedure,
- Patients with a social security in compliance with the French law.
- 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...
- 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,
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Dijon, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Saint-Herblain, France
- Strasbourg, France
- Toulouse, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Dijon, France; Limoges, France; Lyon, France; Marseille, France; Montpellier, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.