Recurrent Adenoid Cystic Carcinoma of the Oral CavityNCT01254734
Transoral Robotic Surgery in Treating Patients With Benign or Stage I-IV Head and Neck Cancer
A study testing transoral robotic surgery, laboratory biomarker analysis and quality-of-life assessment in people with Recurrent Adenoid Cystic Carcinoma of the Oral Cavity and Recurrent Lymphoepithelioma of the Nasopharynx, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies how transoral robotic surgery works in treating patients with benign or stage I-IV head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx
- What is being tested?
- transoral robotic surgery, laboratory biomarker analysis and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Nov 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients clinical, radiologic or pathologic evidence of a benign or malignant tumor in the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, retropharynx or parapharyngeal space
- Surgical access is amenable to treatment with conventional transoral surgical procedures
- ASA (American Society of Anesthesiologists) performance status (PS) of 1-4 or ECOG (Eastern Cooperative Oncology Group) PS 0-3, thereby including a population that stands to gain the most from a minimally invasive surgical approach
- Patients should have no serious acute infection
- Patients must sign a study-specific informed consent form
Who cannot join
- Evidence of distant metastases (below the clavicle) by clinical or radiographic measures
- ASA score > 4; ECOG PS score > 3
- Pregnancy (during first or 3rd trimester - due to risks of anesthesia)
- The presence of medical conditions which contraindicate general anesthesia
- Unexplained fever or untreated, active infection
- Inability to obtain exposure to allow performance of the planned transoral surgical procedure
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- Proposed surgical site with history of prior treatment: radiation
- Tumor adherent to carotid artery or jugular vein
- Fixation to pre-vertebral tumor
- Mandibular invasion
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors
RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies how transoral robotic surgery works in treating patients with benign or stage I-IV head and neck cancer.
Read the detailed description
PRIMARY OBJECTIVES: To conduct a pilot study at City of Hope (COH) which assesses the feasibility and safety of TORS (Transoral robotic surgery), including: total operative time, blood loss, hospitalization time, need to convert to an open procedure, intra-operative as well as post-operative complications. SECONDARY OBJECTIVES: I. To collect data on oncologic outcomes, disease free survival, local control rate and overall survival. II. To collect normative data regarding objective functional outcomes (FO) which may impact quality of life in patients undergoing TORS, including need for adjunctive procedures, such as gastrostomy tube placement and tracheostomy placement, and with regards to speech, swallowing function and pain, using patient-report outcomes instruments. OUTLINE: Patients undergo transoral robotic microsurgery. After completion of study treatment, patients are followed up periodically for 5 years.
- Conditions
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx
- Being tested
- transoral robotic surgery, laboratory biomarker analysis, quality-of-life assessment
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transoral robotic surgeryProcedure or surgery
Undergo transoral robotic microsurgery
laboratory biomarker analysisOther
Correlative studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo transoral robotic microsurgery. Receives: Procedure: transoral robotic surgery; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the feasibility of Transoral Robotic Surgery (TORS) in improving transoral accessibility within the upper aerodigestive tract in patients with benign or malignant head and neck tumors
Measured: From 6 months to 3 years after completion of study treatment
Assessment of the total operative time to perform transoral surgery using TORS in patients with benign or malignant head and neck tumors
Measured: From 6 months to 3 years after completion of study treatment
Assessment of blood loss during transoral surgery using TORS in patients with benign or malignant head and neck tumors
Measured: From 6 months to 3 years after completion of study treatment
Assessment of hospitalization time of in patients with benign or malignant head and neck tumors undergoing transoral surgery using TORS
Measured: From 6 months to 3 years after completion of study treatment
Assessment of the need to convert to an open procedure during transoral surgery using TORS in patients with benign or malignant head and neck tumors
Measured: From 6 months to 3 years after completion of study treatment
Assessment of complications of transoral surgery using TORS in patients with benign or malignant head and neck tumors
Measured: From 6 months to 3 years after completion of study treatment
Secondary outcomes (2)
Collection of data on oncologic outcomes, disease free survival, local control rate and overall survival.
Measured: From 6 months to 3 years after completion of study treatment
Assessment of quality of life outcomes in patients undergoing TORS using patient-report outcomes instruments
Measured: From 6 months to 3 years after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startApr 2011
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: The study will be rewritten as a data registry study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Adenoid Cystic Carcinoma of the Oral CavityStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ellie Maghami, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254734
- Sponsor's protocol ID
- 09206
- Other IDs
- NCI-2010-02169
- Status last verified
- Nov 2014
- First submitted
- 3 Nov 2010
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in Transoral Robotic Microsurgery for Head and Neck Tumors
- ClinicalTrials.gov ID
- NCT01254734
- Acronym / sponsor ID
- 09206
- Conditions
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study will be rewritten as a data registry study
- Enrolment
- 7 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Dec 2010 (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.
RATIONALE: Transoral robotic surgery (TORS) is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery. PURPOSE: This clinical trial studies how transoral robotic surgery works in treating patients with benign or stage I-IV head and neck cancer.
Detailed description
PRIMARY OBJECTIVES: To conduct a pilot study at City of Hope (COH) which assesses the feasibility and safety of TORS (Transoral robotic surgery), including: total operative time, blood loss, hospitalization time, need to convert to an open procedure, intra-operative as well as post-operative complications. SECONDARY OBJECTIVES: I. To collect data on oncologic outcomes, disease free survival, local control rate and overall survival. II. To collect normative data regarding objective functional outcomes (FO) which may impact quality of life in patients undergoing TORS, including need for adjunctive procedures, such as gastrostomy tube placement and tracheostomy placement, and with regards to speech, swallowing function and pain, using patient-report outcomes instruments. OUTLINE: Patients undergo transoral robotic microsurgery. After completion of study treatment, patients are followed up periodically for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: transoral robotic surgery, Other: laboratory biomarker analysis, Procedure: quality-of-life assessmentPatients undergo transoral robotic microsurgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients clinical, radiologic or pathologic evidence of a benign or malignant tumor in the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, retropharynx or parapharyngeal space
- Surgical access is amenable to treatment with conventional transoral surgical procedures
- ASA (American Society of Anesthesiologists) performance status (PS) of 1-4 or ECOG (Eastern Cooperative Oncology Group) PS 0-3, thereby including a population that stands to gain the most from a minimally invasive surgical approach
- Patients should have no serious acute infection
- Patients must sign a study-specific informed consent form
Key exclusion criteria (10 listed)
- Evidence of distant metastases (below the clavicle) by clinical or radiographic measures
- ASA score > 4; ECOG PS score > 3
- Pregnancy (during first or 3rd trimester - due to risks of anesthesia)
- The presence of medical conditions which contraindicate general anesthesia
- Unexplained fever or untreated, active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transoral robotic surgeryUndergo transoral robotic microsurgery | Procedure or surgery | Arm I |
| laboratory biomarker analysisCorrelative studies | Other | Arm I |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I |
Primary outcome
Assessment of the feasibility of Transoral Robotic Surgery (TORS) in improving transoral accessibility within the upper aerodigestive tract in patients with benign or malignant head and neck tumors
Time frame: From 6 months to 3 years after completion of study treatment
Assessment of the total operative time to perform transoral surgery using TORS in patients with benign or malignant head and neck tumors
Time frame: From 6 months to 3 years after completion of study treatment
Assessment of blood loss during transoral surgery using TORS in patients with benign or malignant head and neck tumors
Time frame: From 6 months to 3 years after completion of study treatment
Assessment of hospitalization time of in patients with benign or malignant head and neck tumors undergoing transoral surgery using TORS
Time frame: From 6 months to 3 years after completion of study treatment
Assessment of the need to convert to an open procedure during transoral surgery using TORS in patients with benign or malignant head and neck tumors
Time frame: From 6 months to 3 years after completion of study treatment
Assessment of complications of transoral surgery using TORS in patients with benign or malignant head and neck tumors
Time frame: From 6 months to 3 years after completion of study treatment
2 secondary outcomes
Collection of data on oncologic outcomes, disease free survival, local control rate and overall survival.
Time frame: From 6 months to 3 years after completion of study treatment
Assessment of quality of life outcomes in patients undergoing TORS using patient-report outcomes instruments
Time frame: From 6 months to 3 years after completion of study treatment
Results and safety
The study was stopped early (reason given: The study will be rewritten as a data registry study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 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.
Ellie Maghami principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transoral robotic surgery, laboratory biomarker analysis and quality-of-life assessment in people with Recurrent Adenoid Cystic Carcinoma of the Oral Cavity and Recurrent Lymphoepithelioma of the Nasopharynx, run by City of Hope Medical Center at 1 site in United States.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 Nov 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 United States. 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?
The study was stopped early (reason given: The study will be rewritten as a data registry study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the feasibility of Transoral Robotic Surgery (TORS) in improving transoral accessibility within the upper aerodigestive tract in patients with benign or malignant head and neck tumors (time frame: From 6 months to 3 years after completion of study treatment). The study lists 6 primary outcomes in all. 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 10 Nov 2014.