Quality of Life After Laser Cordectomy in Early Glottic Cancer

July 8, 2014 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Local tumor recurrences
Time Frame: within12 months
within12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Time Frame: 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
Time Frame: pre op, post op 1, 3, 6, 12 months
pre op, post op 1, 3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 99-0579B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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