Идёт набор NCT03805022

Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas

Фаза III С лечением Non-metastatic Soft-tissue Sarcoma Resectable

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Doxorubicin, Ifosfamide or dacarbazine, Doxorubicin, Ifosfamide or dacarbazine.
Кому может быть актуально: Состояния в реестре: Non-metastatic Soft-tissue Sarcoma, Resectable. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Phase III Trial Investigating the Potential Benefit of Intensified Peri-operative Chemotherapy With in High-risk CINSARC Patients With Resectable Soft-tissue SARComas

Обзор

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).

Подробное описание

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.

Вмешательства

Препарат Doxorubicin
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.
Препарат Ifosfamide or dacarbazine
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.
Препарат Doxorubicin
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.
Препарат Ifosfamide or dacarbazine
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.
Препарат At the discretion of the investigator
Drug at the discretion of the investigator.

Первичные конечные точки

Metastasis progression-free survival in High-risk CINSARC patients [Срок оценки: 3 years]

Вторичные конечные точки (10)

Loco-regional relapse-free survival in High-risk CINSARC patients [Срок оценки: 3 years]
Progression-free survival in High-risk CINSARC patients [Срок оценки: 3 years]
Overall survival in High-risk CINSARC patients [Срок оценки: 3 years]
Best overall response in High-risk CINSARC patients [Срок оценки: Throughout the treatment period, an average of 6 months]
Histological response in High-risk CINSARC patients [Срок оценки: An average of 6 months]
Safety profile in High-risk CINSARC patients [Срок оценки: Throughout the treatment period, an average of 6 months]
Progression-free survival in Low-risk CINSARC patients [Срок оценки: 3 years]
Metastasis progression-free survival in Low-risk CINSARC patients [Срок оценки: 3 years]
Loco-regional progression-free survival in Low-risk CINSARC patients [Срок оценки: 3 years]
Overall survival in Low-risk CINSARC patients [Срок оценки: 3 years]

Критерии участия

Критерии включения

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 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.

Критерии исключения

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,
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 :