RecurrentNCT00364962
Treatment Result of KTP Laser Nasopharyngectomy in Recurrent NPC Patients
An observational study of Recurrent and Nasopharyngeal Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Investigate the treatment result of KTP laser nasopharyngectomy in recurrent NPC patients Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Recurrent, Nasopharyngeal Carcinoma
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2006to Jun 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- recurrent NPC patients
Who cannot join
- patients with distant metastasis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Ching-Ting Tan, MD, PhD, 886-2-23123456 ext. 5222, christin@ha.mc.ntu.edu.tw
About this study
Investigate the treatment result of KTP laser nasopharyngectomy in recurrent NPC patients
Read the detailed description
Nasopharyngeal carcinomas (NPCs) are highly radiosensitive tumors, and the primary treatment of NPCs is radiotherapy.1 Because most patients who have NPC are at advanced stages when initially seen, local failures in terms of persistence or recurrence are not infrequent after primary radiotherapy.2,3 Local regional relapse without the presence of distant failure can still be salvaged and should be aggressively treated. Tumors relapsing in the nasopharynx can be salvaged using either re-irradiation or surgical techniques.1 Although re-irradiation to the recurrent tumor can extent the 5-year actuarial survival rate, it is associated with high morbidity. 4-6 Traditional nasopharyngectomy has been associated with local control rates on the order of 40%~50%, but it has also been associated with complications such as palatal defects, trismus, facial scarring, osteomyelitis, etc.7-10 That is the reason why surgeons continue searching for new methods for performing nasopharyngectomies with lower morbidities.
Nasopharyngectomies are difficult to perform because of the inaccessibility of the nasopharynx. More difficulties are encountered in performing a nasopharyngectomy through the nose due to the restricted surgical field. With advances in techniques of endoscopy and application of the potassium-titanyl-phosphate (KTP) laser in surgery, pathologic lesions located either at the choanal margin or in the nasopharynx can easily be managed with instruments inserted via the nasal cavities. The surgical technique had been accepted by the authority journal. This time, we will review the therapeutic result of KTP-laser nasopharyngectomy in patients with recurrent NPC.
- Conditions
- Recurrent, Nasopharyngeal Carcinoma
- Keywords
- NPC, Nasopharyngectomy, KTP laser, recurrence
- Medical subject headings
- Recurrence, Nasopharyngeal Carcinoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2006 (estimated)
- Study startApr 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecurrentStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ching-Ting Tan, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364962
- Sponsor's protocol ID
- 9561703040
- Status last verified
- Aug 2006
- First submitted
- 15 Aug 2006
- Last updated
- 16 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Result of KTP Laser Nasopharyngectomy in Recurrent NPC Patients
- ClinicalTrials.gov ID
- NCT00364962
- Acronym / sponsor ID
- 9561703040
- Conditions
- Recurrent, Nasopharyngeal Carcinoma
- Keywords
- NPC, Nasopharyngectomy, KTP laser, recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Jun 2006
- First posted
- 16 Aug 2006 (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.
Investigate the treatment result of KTP laser nasopharyngectomy in recurrent NPC patients
Detailed description
Nasopharyngeal carcinomas (NPCs) are highly radiosensitive tumors, and the primary treatment of NPCs is radiotherapy.1 Because most patients who have NPC are at advanced stages when initially seen, local failures in terms of persistence or recurrence are not infrequent after primary radiotherapy.2,3 Local regional relapse without the presence of distant failure can still be salvaged and should be aggressively treated. Tumors relapsing in the nasopharynx can be salvaged using either re-irradiation or surgical techniques.1 Although re-irradiation to the recurrent tumor can extent the 5-year actuarial survival rate, it is associated with high morbidity. 4-6 Traditional nasopharyngectomy has been associated with local control rates on the order of 40%~50%, but it has also been associated with complications such as palatal defects, trismus, facial scarring, osteomyelitis, etc.7-10 That is the reason why surgeons continue searching for new methods for performing nasopharyngectomies with lower morbidities.
Nasopharyngectomies are difficult to perform because of the inaccessibility of the nasopharynx. More difficulties are encountered in performing a nasopharyngectomy through the nose due to the restricted surgical field. With advances in techniques of endoscopy and application of the potassium-titanyl-phosphate (KTP) laser in surgery, pathologic lesions located either at the choanal margin or in the nasopharynx can easily be managed with instruments inserted via the nasal cavities. The surgical technique had been accepted by the authority journal. This time, we will review the therapeutic result of KTP-laser nasopharyngectomy in patients with recurrent NPC.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- recurrent NPC patients
Key exclusion criteria (1 listed)
- patients with distant metastasis
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2006.
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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.
Ching-Ting Tan, MD, PhD principal investigator
National Taiwan University 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 Recurrent and Nasopharyngeal Carcinoma, run by National Taiwan University 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 16 Aug 2006. 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 Ching-Ting Tan, MD, PhD (886-2-23123456 ext. 5222, christin@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 16 Aug 2006.