2024-513576-18-00暂停3 期
Induction chemotherapy followed by standard concurrent chemoradiotherapy in cervical cancer with para-aortic lymph node involvement: A phase III, multicenter, parallel-group randomized, controlled trial - ONCOCOL-01
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 310
- 试验地点
- 13
- 主要终点
- Overall survival defined as the time from the date of randomization to the date of death from any cause
研究概览
简要总结
Evaluate whether induction chemotherapy with three cycles of Carboplatin and Paclitaxel followed by standard treatment (concurrent chemoradiotherapy) improves overall survival compared to standard treatment alone, in patients with locally advanced cervical cancer with para-aortic lymph node involvement.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with cervical cancer WITH para-aortic lymph node involvement determined by either a positive 18F-FDG PET-CT (visual interpretation of metabolic activity of para-aortic lymph node, greater than the background noise), or by histological examination of para-aortic lymph nodes if negative 18F-FDG PET-CT
- •Signed written informed consent
- •Affiliated to a social security insurance or equivalent
- •Age ≥18 years
- •ECOG performance status of 0 to 2
- •FIGO stage IIIC2 or IVA WITH para-aortic lymph node involvement at the time of diagnosis
- •Adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma
- •Normal renal function (creatinine clearance ≥60 mL/min)
- •Normal liver function (total bilirubin <1.5 times the upper limit of normal (ULN) and AST <3 ULN)
- •Normal haematological assessment (platelets >100×109/L and neutrophils >1.5×109/L)
- •Women of childbearing potential and not postmenopausal must have a negative blood serum or urine pregnancy test before starting the study treatment
排除标准
- •Patients who have received prior chemotherapy or radiotherapy for their cervical cancer
- •Pregnant or breastfeeding women
- •History of invasive cancer (in the last five years) other than non-melanoma skin cancer
- •Acute, uncontrolled cardiovascular disease
- •Peripheral neuropathy of CTCAE grade 3-4
- •Known hypersensitivity to Paclitaxel, Cisplatin or other platinum-containing compounds
- •Patients under legal protection
结局指标
主要结局
Overall survival defined as the time from the date of randomization to the date of death from any cause
Overall survival defined as the time from the date of randomization to the date of death from any cause
次要结局
- Tumour response at the end of standard treatment (concurrent chemoradiotherapy), based on investigator assessments according to both RECIST 1.1 and PERCIST 1.0 criteria
- Progression-free survival, defined as the time from the date of randomization to the date of progression (based on investigator assessments according to RECIST 1.1 criteria) or the date of death from any cause, whichever occurs first
- Site of disease recurrence (local, pelvic and/or para-aortic lymph nodes, distant)
- Health-related quality of life, assessed using the EORTC QLQ-C30 questionnaire and the QLQ-CX24 module
- Adverse events occurring from the first study treatment administration, assessed based on the NCI-CTCAE version 5.0
研究者
MOTTON Stéphanie
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (13)
Loading locations...
相似试验
进行中（未招募）
1 期
Induction chemotherapy followed by standard concurrent chemoradiotherapy in cervical cancer with para-aortic lymph node involvement: A phase III, multicenter, parallel-group randomized, controlled trial - ONCOCOL-01MedDRA version: 21.1Level: LLTClassification code: 10008229Term: Cervical cancer Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10008236Term: Cervical cancer stage IV Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10008235Term: Cervical cancer stage III Class: 10029104Cervical CancerCTIS2024-513576-18-00Centre Hospitalier Universitaire De Toulouse310
进行中（未招募）
不适用
Induction chemotherapy followed by chemoradiation with cetuximab and cisplatin for inoperable squamous cell carcinoma of the head and neck.Inoperable squamous cell carcinoma of the head and neck.EUCTR2006-003381-33-SIInstitute of Oncology Ljubljana
尚未招募
不适用
Induction chemotherapy followed by chemoradiation in loco-regionally advanced nasopharyngeal carcinomaCTRI/2022/08/044617Jawaharlal Institute of Postgraduate Medical Education and Research
进行中（未招募）
不适用
Phase I/II study on induction chemotherapy followed by chemoradiation with or without lapatinib, a dual EGFR/ErbB2 kinase inhibitor, in patients with locally advanced resectable larynx and hypopharynx squamous cell carcinomaEUCTR2006-002667-33-BEEuropean Organisation for Research and Treatment of Cancer
招募中
不适用
A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancerPancreatic cancerJPRN-UMIN000034410Keio University School of Medicine40