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Quality of Life After Laser Cordectomy in Early Glottic Cancer

2014年7月8日 更新者:Fang Tuan-Jen、Chang Gung Memorial Hospital

Laryngeal cancer is common in the Taiwanese populations. Before early 80's, open laryngectomy was the suggested treatment modality for laryngeal cancer. Patients of laryngectomy lost speech and should communicate by using prosthesis. So after 90's, medical organ preservation by chemoradiation therapy took the place of operation.

Unfortunately, from the recent review, five-year survival rate was decreasing and is even lower than that reported 10 years ago. In 1983-1985 it was 68.1% but decreased to 64.7% in 1992-1999. It is the only cancer type of decreasing survival in 24 index cancers.

Laser resection of laryngeal tumor was first reported by Jako and Strong and widely used in the Europe. Dr Steiner and his colleagues developed a non-en block resection technique made microscopic resection more easily and would not be limited by tumor location or size so much. The investigators used transoral microscopic laser (TLM) in early glottic cancer and reported five-year overall survival as 97%. TLM five-year disease control rate was reported as 85%. There are some reports about TLM in advanced stage laryngeal cancer and overall 5-year survival rate can be achieved as high as 55%. Present project is planning to develop a comprehensive organ preservation protocol based on microinvasive TLM as primary treatment modality for early glottic cancer without neck or distant metastasis. The objects of the project are as followed.

  1. Long term outcomes by performing the treatment protocol. The outcome measurements include local control rate, overall and disease specific survival, larynx preservation rate.
  2. The difference between surgical samples and pretreatment imaging examination.
  3. The role of adjuvant therapy.
  4. Management and follow-up in neck metastasis.
  5. Searching for risk factors and predictor factors.
  6. Adequate salvage treatments in local or regional recurrence.
  7. Realizing failure patterns and appropriate follow-up protocol according to it.

研究概览

地位

未知

详细说明

Laryngeal cancer is associated with a cure rate from 30 to 90% by primary treatment with irradiation therapy, open surgical excision or microinvasive endolaryngeal surgical excision based on the stages. Prior to advances in endoscopic surgical techniques, radiation therapy with or without chemotherapy offered treatment with less morbidity than open surgical resection. Therefore, throughout the later part of the 20th century, radiation therapy became the standard management for laryngeal cancer.

In the America, the Surveillance, Epidemiology, and End Results (SEER) Program and the National Cancer Data Base (NCDB) data have shown the survival rate of laryngeal cancer decreased in the 1990's. Five-year relative survival for laryngeal squamous cell carcinoma recorded in the NCDB ranged from a high of 68.1% in 1985 to a low of 62.8% in 1993.

Treatment patterns have changed with an increase in nonsurgical management with irradiation alone and with chemoradiation. Radiation or chemoradiation therapies provided a treatment choice to preserve the larynx. However, the increase in nonsurgical management parallels the increase in mortality across the years of study for which survival analysis was performed (1985-1996).

In the past two decades, the evolution of microinvasive TLM surgery makes it possible to eradicate tumors with preserving laryngeal functions. It has been demonstrated that cure rates can be obtained that are comparable with other treatment modalities. In addition, morbidity from treatment by TLM is substantially less than morbidity associated with open surgical techniques and may be the same or less than morbidity associated with radiation or chemoradiation therapy. Therefore, TLM as an initial treatment modality for laryngeal cancer is more commonly practiced.

TLM offers advantages over other forms of treatment. First it can usually be accomplished in a single intervention in early stage of disease- thus decreasing the overall treatment time and cost when compared to radiation therapy. Second, as opposed to open surgical techniques, resection by endoscopic methods does not require a tracheotomy for airway maintenance. Third, rehabilitation time to independent swallowing has been shown in multiple series to be reduced compared with open surgical techniques. And forth, it leaves all opportunities in adjuvant or salvage therapy. Due to these advances, TLM surgery of laryngeal cancer is becoming more widely used in recent years for a focal small lesion and has also been demonstrated to have a comparable survival rate and local control rate in advanced stage to other forms of treatment.

The primary object of the study is to improve the tumor control rate with an organ preservation protocol based on microinvasive TLM surgery. This prospective phase II study is expected to provide evidence in future treatment plan for laryngeal cancer.

研究类型

观察性的

注册 (预期的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 95年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with early glottic cancer without neck or distant metastasis and were managed by Laser cordectomy in a tertian referral hospital in Taiwan.

描述

Inclusion Criteria:

1. Early glottic cancer without neck or distant metastasis 2. Cell type : squamous cell carcinoma

Exclusion Criteria:

1. Had previous head and neck radiation or surgery history. 2. Tumor extended beyond subglottis.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Local tumor recurrences
大体时间:within12 months
within12 months

次要结果测量

结果测量
大体时间
Chang from baseline cancer-related quality of life within 12 months. Questionnaire : European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score C30
大体时间:pre-op, post op 1, 3, 6, 12 months
pre-op, post op 1, 3, 6, 12 months
Change of voice quality from baseline. Measured by voice laboratory test including Maximal Phonation Time,S/Z ratio,Fundamental Frequency,Jitter, Shimmer,Harmonics to Noise ratio
大体时间:pre op, post op 1, 3, 6, 12 months
pre op, post op 1, 3, 6, 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年5月1日

初级完成 (预期的)

2015年4月1日

研究完成 (预期的)

2015年4月1日

研究注册日期

首次提交

2014年6月13日

首先提交符合 QC 标准的

2014年7月8日

首次发布 (估计)

2014年7月9日

研究记录更新

最后更新发布 (估计)

2014年7月9日

上次提交的符合 QC 标准的更新

2014年7月8日

最后验证

2014年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 99-0579B

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