A Feasibility Study of Genomically Guided Radiation Dose Personalization in the Management of Locally Advanced Non-Small Cell Lung Cancer

H. Lee Moffitt Cancer Center and Research Institute1 个研究点分布在 1 个国家目标入组 3 人2023年5月25日

适应症Nonsmall Cell Lung Cancer Nonsmall Cell Lung Cancer, Stage II Nonsmall Cell Lung Cancer Stage III Unresectable Non-Small Cell Lung Carcinoma

概览

阶段: 早期 1 期
干预措施: 未指定
疾病 / 适应症: Nonsmall Cell Lung Cancer
发起方: H. Lee Moffitt Cancer Center and Research Institute
入组人数: 3
试验地点: 1
主要终点: Rate of Unacceptable Toxicity
状态: 已完成
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) with concurrent chemotherapy in the management of stage II and III non-small cell lung cancer (NSCLC).

注册库

clinicaltrials.gov

开始日期

2023年5月25日

结束日期

2024年8月21日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

H. Lee Moffitt Cancer Center and Research Institute

责任方

Sponsor

入排标准

入选标准

•Diagnosis of AJCC Stage 2 or Stage 3 unresectable NSCLC as determined by a multidisciplinary oncology team
•Confirmation of NSCLC with availability of fresh tumor biopsy by tissue biopsy which can include adenocarcinoma, squamous cell, large cell carcinoma, or NSCLC not otherwise specified
•Life expectancy \>12 weeks
•Normal renal (creatinine \<1.5 × upper limit of normal \[ULN\]), liver (bilirubin \< 1.5 × ULN, transaminases \<3.0 × ULN, except in known hepatic disease, wherein may be \<5 × ULN) and blood counts (white blood cells ≥2.5, neutrophils ≥1000, platelets ≥50, 000, hemoglobin ≥8)
•Age ≥ 18 years
•Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
•There is no limit on prior systemic or therapies
•Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
•Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before any study related procedures occur.

排除标准

•Current or prior participation in a study of an investigational agent or investigational device within 2 weeks of the first dose of study treatment
•Major surgery or significant traumatic injury that has not been recovered from 14 days before the initiation of study drug
•Women who are pregnant or breastfeeding
•History of allergy or hypersensitivity to any of the study drugs or study drug components
•Concurrent brain metastases or leptomeningeal disease
•History of prior malignancy within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of \> 90%), such as but not limited to, non-melanoma skin carcinoma, ductal carcinoma in situ, or stage I endometriod uterine cancer, and others at the discretion of the PI
•Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
•• Patients with vitiligo or alopecia
•• Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
•• Any chronic skin condition that does not require systemic therapy

结局指标

主要结局

Rate of Unacceptable Toxicity

时间窗: 12 weeks after start of treatment

Rate of Unacceptable Toxicity will be measured during 12 week period following study enrollment. Unacceptable toxicity is defined as any grade 4 or 5 adverse event (AE) probably or definitely related to experimental dose escalated radiation therapy