A Prospective Single Arm Clinical Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced Sinonasal Malignant Melanoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Sinonasal mucosal melanoma (SNMM) is a very rare tumor, and SNMM is highly aggressive in nature, with a 5-year survival rate of about 20~30%. Most patients underwent local recurrence and distant metastasis within one or two years of treatment.
There is no unified standard for the treatment of SNMM.The principle of treatment for surgically resectable stage T3 and partial T4 SNMM is complete resection of the primary tumor, combined with postoperative radiotherapy. While locally unresectable SNMM has a poorer prognosis, lower incidence, fewer clinical data have been reported.
This study will explore the role of preoperative radiotherapy and chemotherapy in improving the 2-year OS rate, loco-regional control rate and distant metastasis rate.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old;
- •Pathologically confirmed with sinonasal mucosal melanoma;
- •Eligible for assessment by enhanced contrast computed tomography scan or magnetic Resonance Imaging (MRI);
- •T4N0-1M0 according to the 8th edition American Joint Committee on Cancer (AJCC) staging system, and breaks through the natural anatomical boundaries of orbital fascia or dura mater; or 2) any Tumor stage, with retropharyngeal node metastasis. unresectable tumor after multi-disciplinary team (MDT) discussion.
- •Eastern Cooperative Oncology Group (ECOG) score between 0 to 2;
- •No distant metastasis;
- •Adequate organ function;
- •Sign the informed consent forms.
排除标准
- •There is evidence or suspicious of distant metastasis on clinical examination or imaging examination;
- •suffered from uncontrolled concurrent diseases that may interfere with treatment;
- •Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.);
- •With surgical contraindications: severe cardiopulmonary disease, coagulation dysfunction, etc;
- •With and conditions that interfere with patient compliance or safety;
- •With severe mental or neurological diseases;
- •Uncontrolled active infection diseases;
- •Pregnant or breastfeeding women;
- •Patients without personal freedom or independent civil capacity;
- •Other situations that are not suitable.
研究组 & 干预措施
Preoperative radiotherapy and chemotherapy
Preoperative radiotherapy and chemotherapy plus endoscopic surgery
干预措施: endoscopic surgery (Procedure)
Preoperative radiotherapy and chemotherapy
Preoperative radiotherapy and chemotherapy plus endoscopic surgery
干预措施: intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy (Radiation)
Preoperative radiotherapy and chemotherapy
Preoperative radiotherapy and chemotherapy plus endoscopic surgery
干预措施: Chemotherapy drug (Drug)
结局指标
主要结局
Overall survival
时间窗: From date of first treatment until the date of death from any cause,through study completion,up to 2 years.
2 year Overall Survival rate
次要结局
- Regional progression free survival(From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years)
- ORR(From date of first treatment to the date of best overall response before surgery, assessed up to 6 months)
- Progression-free survival(From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to2 years)
- Local progression free survival(From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years)
- Distant metastasis free survival(From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years)
研究者
Hongmeng Yu
Principal Investigator,Head of Rhinology
Eye & ENT Hospital of Fudan University