Carcinoma of GlottisNCT02184403
Quality of Life After Laser Cordectomy in Early Glottic Cancer
An observational study of Carcinoma of Glottis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Carcinoma of Glottis
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2010to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1. Early glottic cancer without neck or distant metastasis 2. Cell type : squamous cell carcinoma
Who cannot join
- 1. Had previous head and neck radiation or surgery history. 2. Tumor extended beyond subglottis.
Trial locations and contacts
1 site in 1 country.
Tuan-Jen Fang, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Linkou District
Tuan-Jen Fang, fang3109@cgmh.org.tw
About this study
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.
Read more
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.
- Long term outcomes by performing the treatment protocol. The outcome measurements include local control rate, overall and disease specific survival, larynx preservation rate.
- The difference between surgical samples and pretreatment imaging examination.
- The role of adjuvant therapy.
- Management and follow-up in neck metastasis.
- Searching for risk factors and predictor factors.
- Adequate salvage treatments in local or regional recurrence.
- Realizing failure patterns and appropriate follow-up protocol according to it.
Read the 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.
- Conditions
- Carcinoma of Glottis
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor recurrences
Measured: within12 months
Secondary outcomes (2)
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
Measured: 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
Measured: pre op, post op 1, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startMay 2010
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of GlottisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Tuan-Jen, Chang Gung Memorial Hospital
- Investigators
- Tuan-Jen Fang, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184403
- Sponsor's protocol ID
- 99-0579B
- Status last verified
- Jul 2014
- First submitted
- 13 Jun 2014
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Laser Cordectomy in Early Glottic Cancer
- ClinicalTrials.gov ID
- NCT02184403
- Acronym / sponsor ID
- 99-0579B
- Conditions
- Carcinoma of Glottis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Long term outcomes by performing the treatment protocol. The outcome measurements include local control rate, overall and disease specific survival, larynx preservation rate.
- The difference between surgical samples and pretreatment imaging examination.
- The role of adjuvant therapy.
- Management and follow-up in neck metastasis.
- Searching for risk factors and predictor factors.
- Adequate salvage treatments in local or regional recurrence.
- Realizing failure patterns and appropriate follow-up protocol according to it.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1. Early glottic cancer without neck or distant metastasis 2. Cell type : squamous cell carcinoma
Key exclusion criteria (1 listed)
- 1. Had previous head and neck radiation or surgery history. 2. Tumor extended beyond subglottis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Local tumor recurrences
Time frame: within12 months
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuan-Jen Fang, MD contact
Tuan-Jen Fang, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma of Glottis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuan-Jen Fang, MD (fang3109@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor recurrences (time frame: within12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.