Intensity-modulated Radiotherapy Combined With Lobaplatin-based Concurrent Chemotherapy in the Treatment of Elderly Patients With Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
This prospective, multicenter, single-arm, open-label phase II clinical study aimed to investigate the efficacy and safety of intensity-modulated radiotherapy combined with lobaplatin-based concurrent chemotherapy in the treatment of elderly patients with nasopharyngeal carcinoma
详细描述
Lobaplatin, as a third-generation platinum-based chemotherapeutic agent, demonstrates equivalent therapeutic efficacy to cisplatin but significantly lower toxicity. Preliminary clinical trials have confirmed that lobaplatin shows substantial effectiveness in treating various cancers including breast cancer, esophageal cancer, colorectal cancer, and cervical cancer. Importantly, lobaplatin does not exhibit cross-resistance with cisplatin or carboplatin, indicating a promising application prospect.
Currently, lobaplatin has demonstrated clear efficacy in non-elderly nasopharyngeal carcinoma (NPC) chemotherapy. Guo Xiang et al. have confirmed that for non-elderly NPC patients, induction chemotherapy with lobaplatin followed by concurrent chemoradiotherapy may be a treatment option for locally advanced NPC. However, there is very limited research reporting on the use of lobaplatin in elderly NPC patients.
Based on the above theoretical considerations and our research results, lobaplatin shows good safety and reliable efficacy in treating elderly NPC, with minimal gastrointestinal reactions and low incidence of renal, neurotoxic, and ototoxic effects. This approach significantly enhances the quality of life for locally advanced elderly NPC patients. Therefore, the efficacy and safety of lobaplatin in concurrent chemotherapy for elderly NPC deserve further investigation. This study aims to evaluate the recent efficacy, safety, and toxic side effects of lobaplatin combined with intensity-modulated radiotherapy in the treatment of elderly NPC. Designed as a multicenter, open-label, prospective study, it aims to verify whether lobaplatin is an effective concurrent chemotherapeutic agent for elderly NPC, while further improving the quality of life for these patients under guarantees of therapeutic efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma;
- •Stage II-IVa (UICC 8th edition);
- •Acceptable induction chemotherapy and Tarceva targeted therapy;
- •No history of other malignant tumors;
- •Male or female, aged 65-80 years.
- •Liver function: Total bilirubin ≤ Upper Limit of Normal (ULN); AST and ALT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 5 times ULN;
- •Renal function: Creatinine clearance ≥ 60 ml/min or Creatinine ≤ 1.5 × ULN;
- •Hematological tests: Absolute Neutrophil Count (ANC) ≥ 2 × 10^9/L, Platelet count ≥ 100 × 10^9/L, and Hemoglobin ≥ 9 g/dL;
- •No severe dysfunction of vital organs such as heart and lung;
- •PS score ≤ 2 points
排除标准
- •Distant metastases detected before treatment;
- •Refusal to sign the informed consent form;
- •Patients who cannot comply with regular follow-up due to psychological, social, family, or geographical reasons;
- •Simultaneously receiving other experimental treatments in clinical trials (during the treatment phase of clinical research);
- •Severe, uncontrolled infections or medical conditions;
- •Vital organ dysfunction, decompensated heart, lung, kidney, or liver failure, unable to tolerate radiotherapy and chemotherapy;
- •Laboratory tests: Total bilirubin > Upper Limit of Normal (ULN); AST and/or ALT > 1.5 times ULN with alkaline phosphatase > 2.5 times ULN;
- •Factors affecting drug administration, distribution, metabolism, and excretion, such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.;
- •Long-term use of immunosuppressants after organ transplantation;
- •Patients with a history of other malignant tumors before enrollment.
研究组 & 干预措施
Experimental
in the treatment of elderly patients with nasopharyngeal carcinoma
干预措施: IMRT combined with lobaplatin-based concurrent chemotherapy (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: 6 months
ORR encompasses both CR and PR.
次要结局
- Safety(3 months)
- Overall survival (OS)(3 years)
- Locoregional relapse-free survival (LRFS)(3 years)
- Distant metastasis-free survival (DMFS)(3 years)
- Progression-free survival (PFS)(3 years)
研究者
San-Gang Wu
Clinical Professor
The First Affiliated Hospital of Xiamen University