NCT03214003已完成不适用
Twice-daily Radiotherapy by Simultaneous Integrated Boosting Technique Versus Twice-daily Standard Radiotherapy for Patients With Limited-stage Small Cell Lung Cancer: a Multicenter, Randomized, Controlled, Phase III Study
Anhui Shi, MD1 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2017年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This trial is a multicenter, perspective, non-blinded, randomized controlled phase 3 trial. In order to establish whether the SIB technique can improve the results of twice-daily chemo-RT for patients with LS-SCLC, the investigators will primarily compare survival of patients treated with standard chemotherapy (cisplatin and etoposide) and either SIB twice-daily RT or standard dose twice-daily RT.
详细描述
Three hundred and twenty-six patients with a histological or cytological proven diagnosis of SCLC will be recruited from 35 centers in 14 areas including provinces, municipalities and autonomous region, from May 2017 to May 2020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Read the patient information and Sign the informed consent before enrollment
- •Either sex, age ≥18 and ≤70
- •Histologically or cytologically confirmed SLCL
- •Limited stage disease(AJCC, 2009 version 7), stage I-III(T any, N any, M0) that can be safely treated with definitive radiation doses, excludes T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, clinical nonmalignant diagnosis by investigator when the pleural is too few to obtain cytological evidence.
- •measurable lesion according RECIST 1.1
- •PS ECOG 0-1
- •having zero to two cycles of systemic chemotherapy with etoposide and cisplatin (cisplatin 60-80 mg/m2 at day1 or divided into two to three days, etoposide 100-120 mg/m2 at day 1 to 3, Q21d, and the treatment delay between two cycles shouldn't be more than 14days).
- •patients especially female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception. Man must also use adequate contraception
- •adequate haematological function: white blood cell ≥3.0×109/L , neutrophils ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥90g/L.
- •adequate liver and renal function: total bilirubin ≤1.5 ×upper limit normal , alanine transaminase and aspartate aminotransferase ≤1.5 ×upper limit normal, normal serum creatinine and/or calculated creatinine clearance ≥60ml/min.
排除标准
- •prior surgical resection of the primary tumor or prior RT for lung cancer
- •mixed small-cell and non-small-cell histological features
- •contemporaneous immunotherapy or target therapy
- •pregnancy or lactation
- •physical or mental disease that could impact treatment plan
- •unable to understand the trial, or could not follow the process
- •to refuse the sign the informed consent.
- •no history of previous malignancy in the past 5 years (except non-melanomatous skin or in situ servix carcinoma)
- •be allergic to any known protocol in this trail
- •be enrolled in other clinical trial in past 30days
结局指标
主要结局
Overall survival
时间窗: 5 years
from the starting date of treatment until the date of death from any cause
次要结局
- Local Progression Free Survival(5 years)
- health related quality of life(from baseline, immediately after radiotherapy and an average of 3 months up to 24 months. Then through study completion, an average of 6 months.From date of randomization until the date of death from any cause, assessed up to 120 months.)
- Metastasis Free Survival(5 years)
- acute and late toxicity(from baseline, immediately after radiotherapy and an average of 1 week up to 12 weeks, an average of 3 months up to 24 months. Up to 120 weeks.)
研究者
Anhui Shi, MD
associate chief physician
Peking University Cancer Hospital & Institute
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Phase II/III Trial of CCRT With or Without JP001 for Newly Diagnosed GBMGlioblastomaNCT03008148Johnpro Biotech, Inc.288
招募中
3 期
Radiotherapy Alone Versus Concurrent Chemo-radiotherapy for Nasopharyngeal Carcincoma Patients With Undectable EBV DNA After One Cylce Neoadjuvant ChemotherpyNasopharyngeal CarcinomaNCT05674305Fudan University366
Unknown
3 期
Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02Esophageal NeoplasmsNCT03308552Chinese Academy of Medical Sciences164
已完成
3 期
Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)HIV-1 InfectionNCT04233879Merck Sharp & Dohme LLC599
已完成
3 期
Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCCOropharynx CancerHypopharynx CancerLarynx CancerOral CancerNCT00158652Groupe Oncologie Radiotherapie Tete et Cou840