JPRN-jRCTs031220446招募中3 期
JCOG2102: Randomized phase III trial of Neo-adjuvant and adjuvant chemotherapy vs Adjuvant Chemotherapy alone for LocalizEd Soft tissue Sarcoma - NACLESS
TANAKA Kazuhiro0 个研究点目标入组 224 人开始时间: 2022年11月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •(1) Grade 2 or 3 (FNCLCC histological grading system) non-round cell soft-tissue sarcoma with histology of undifferentiated sarcoma (pleomorphic, spindle cell), adult fibrosarcoma, myxofibrosarcoma, leiomyosarcoma, synovial sarcoma, liposarcoma (dedifferentiated, myxoid, pleomorphic), pleomorphic rhabdomyosarcoma, malignant peripheral nerve sheath tumor, angiosarcoma (WHO classification 2020) using open biopsy specimen
- •(2) 10 or more unstained tumor tissue slides are available
- •(3) Primary tumor
- •(4) Tumor in the extremities or trunk
- •(5) T2-4N0M0 (UICC/AJCC, 8th edition) and deeply seated (localized deeper than the investing fascia, invades the investing fascia, or penetrates the investing fascia) according to the latest imaging studies
- •(6) Having measurable lesion on MRI axial section
- •(7) resectable with marginal or wide margin
- •(8) Age between 16 and 70 years
- •(9) ECOG Performance status (PS) of 0 or 1
- •(10) No history of chemotherapy nor radiation therapy for any cancer including NRC-STS
- •(11) All of the following are met for the most recent laboratory findings within 14 days prior to enrollment:
- •(i) Neutrophil count >= 1,500/mm3
- •(ii) Hemoglobin >= 8.0 g/dL (No blood transfusion within 14 days prior to the test used for registration)
- •(iii) Platelet count >=100,000/mm3
- •(iv) Total bilirubin <=1.5 mg/dL
- •(v) AST<=100 U/L
- •(vi) ALT<=100 U/L
- •(vii) Serum creatinine<=1.5 mg/dL
- •(viii) Creatinine clearance >=60 mL/min
- •(12) The latest ECG within 35 days prior to enrollment shows normal or no changes requiring treatment
- •(13) Written informed consent
排除标准
- •(1) Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more
- •(2) Active infection requiring systemic therapy
- •(3) Body temperature >= 38 degrees Celsius
- •(4) Women (possibly) in pregnancy, within 28 days postpartum, or breast feeding. Men who wish to get his partner pregnant
- •(5) Patients with psychiatric disorders or psychiatric symptoms
- •(6) Patients requiring systemic steroid medication
- •(7) Poorly controlled diabetes mellitus or routine administration of insulin
- •(8) Poorly controlled hypertension
- •(9) Unstable angina within 3 weeks, or with a history of myocardial infarction
- •(10) Poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy
- •(11) Positive HBs antigen
研究者
相似试验
进行中（未招募）
1 期
.a.EUCTR2021-003751-42-ITIRCCS ISTITUTO CLINICO HUMANITAS160
进行中（未招募）
2 期
JCOG1306:Randomized phase II/III study of adjuvant chemotherapy with Adriamycin+Ifosfamide vs Gemcitabine+Docetaxel for high-grade soft tissue sarcoma ( AI vs GD for STS RPII/III )JPRN-jRCTs031180003Ozaki Toshifumi140
招募中
3 期
JCOG2214INT: A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal SarcomaJPRN-jRCTs031230482OZAKI Toshifumi250
进行中（未招募）
1 期
Randomized Controlled Trial comparing two groups of Patients with High-Risk, Localized Soft Tissue Sarcoma of the Extremity: the first one receiving Neoadjuvant Pembrolizumab with Radiotherapy and Adjuvant Pembrolizumab after surgery, and the second one receiving Radiotherapy and surgery, aiming to assess the safety and efficacy profile of PembrolizumabThis trial investigates whether neoadjuvant radiotherapy combined with pembrolizumab followed by surgical resection and adjuvant pembrolizumab improves disease-free survival for patients with high-risk soft tissue sarcoma of the extremity (undifferentiated pleomorphic sarcoma or dedifferentiated/pleomorphic liposarcoma, tumor size > 5 cm, grade 2 or 3 out of 3) compared to radiotherapy alone followed by surgical resectionMedDRA version: 20.0Level: PTClassification code 10024629Term: Liposarcoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10041298Term: Soft tissue sarcomas histology unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001360-39-ITSARC110
进行中（未招募）
1 期
A Study of Nivolumab Plus NKTR-214 vs Nivolumab Alone vsStandard of Care in Participants With Bladder Cancer That HasInvaded Into the Muscle Wall of the BladderEUCTR2018-002676-40-ESBristol-Myers Squibb International Corporation720