EUCTR2018-000186-36-FR进行中（未招募）1 期
Phase III trial investigating the potential benefit of intensified peri-operative Chemotherapy in patients with in high-risk CINSARC patients with resectable soft-tissue SARComas - CIRSARC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 334
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. 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,
- •2. Grade 2 or 3 according to the FNCLCC grading system,
- •3. Available archived tumour sample for research purpose,
- •4. Non-metastatic and resectable disease,
- •5. No prior treatment for the disease under study,
- •6. Age = 18 years,
- •7. Life expectancy = 3 months,
- •8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 1,
- •9. 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,
- •10. 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,
- •11. Voluntarily signed and dated written informed consents prior to any study specific procedure,
- •12. Patients with a social security in compliance with the French law.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 284
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clearcell sarcoma, embryonal and alveolar rhabdomyosarcoma,
- •2. 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,
- •3. Any other contraindication to anthracycline and Ifosfamide-based chemotherapy,
- •4. Participation to a study involving a medical or therapeutic intervention in the last 28 days,
- •5. Known infection with HIV, hepatitis B, or hepatitis C,
- •6. Females who are pregnant or breast-feeding,
- •7. 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,
- •8. Individuals deprived of liberty or placed under legal guardianship,
- •9. Unwillingness or inability to comply with the study protocol for any reason.
研究者
相似试验
进行中（未招募）
不适用
_PROSTATIC ADENOCARCINOMA WITH HIGH RISK OF RECURRENCE.MedDRA version: 18.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022037-29-DEICANCER700
进行中（未招募）
不适用
AFU-GETUG20EUCTR2010-022037-29-SKICANCER700
进行中（未招募）
不适用
A phase III trial investigating the efficacy and safety of Grazax in children aged 5-16 years with grass pollen induced rhinoconjunctivitis with or without asthmaIgE Mediated allergy (hay fever, rhinoconjunctivitis) to grass pollen (Timothy grass, Phleum pratense) with or without asthmaEUCTR2006-003415-46-DEALK-Abello, Group Clinical Development
进行中（未招募）
1 期
Trial in patients with newly diagnosed myeloma to evaluate the effect of isatuximab in induction therapy with lenalidomide / bortezomib / dexamethasone and in lenalidomide maintenance treatmentewly diagnosed symptomatic multiple myelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-004768-37-DERuprecht-Karls-University Heidelberg, Medical Faculity, represented by University Hospital Heidelberg662
招募中
1 期
A randomized phase III trial assessing the benefit of the addition of isatuximab to lenalidomide / bortezomib / dexamethasone (RVd) induction and lenalidomide maintenance in patients with newly diagnosed multiple myeloma (GMMG-HD7)MedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104Multiple MyelomaCTIS2024-513464-26-00niversitaetsklinikum Heidelberg AöR662