Oropharyngeal CancerPhase 2NCT02225496
Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
A Phase 2 study testing Transoral Robotic Surgery (TORS), Modified Barium Swallow (MBS) and Questionnaires in people with Oropharyngeal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Standard-of-care treatment options for oropharyngeal cancer often result in long-term side effects that interfere with normal quality of life. A minimally-invasive transoral robotic surgery (TORS) approach has been developed to operate on the disease site while affecting the surrounding tissue as little as possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer
- What is being tested?
- Transoral Robotic Surgery (TORS), Modified Barium Swallow (MBS) and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2014to 8 Dec 2017
- Phase
- Phase 2
- 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 with a previously untreated, T1 or T2, N0-N2b transorally resectable (as determined by the treating surgeon), histologically proven HPV positive, squamous cell carcinoma (SCC) of the oropharynx.
- Eastern Cooperative Oncology Group (ECOG) PS 0-2.
- Age >/= 18 years.
- Negative serum pregnancy test in females of childbearing potential.
- Patients must sign a study-specific informed consent form prior to treatment.
Who cannot join
- Evidence of distant metastases (below the clavicle) by clinical or radiographic examination.
- Evidence of any other primary cancers or metastases. Evidence of deep soft-tissue or bony invasion, which would preclude TMIS by clinical and/or radiographic exam.
- Contraindications to general anesthesia.
- Patients who have had chemotherapy or radiotherapy to the oropharynx prior to entering the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with tumors whose resection would necessitate a free-tissue transfer for reconstruction of the surgical defect.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study of Transoral Robotic Surgery With Adjuvant Therapy for Surgically Resectable HPV-positive Oropharyngeal Cancer
Standard-of-care treatment options for oropharyngeal cancer often result in long-term side effects that interfere with normal quality of life. A minimally-invasive transoral robotic surgery (TORS) approach has been developed to operate on the disease site while affecting the surrounding tissue as little as possible. Researchers think that this approach may help to control the disease and avoid such long-term side effects.
The goal of this clinical research study is to learn if minimally-invasive transoral robotic surgery (TORS) can help to control HPV-positive oropharyngeal cancer. Transoral means through the mouth. The TORS approach is called the Intuitive Surgical da Vinci Surgical System.
Researchers also want to learn if this surgery affects participants' ability to speak and swallow.
Read the detailed description
Study Surgery:
If you are found to be eligible to take part in this study, you will be scheduled for surgery. You will receive general anesthesia to make you sleep during the procedure. You will be asked to sign a separate consent form that describes the anesthesia and its risks. If the doctor thinks it is needed, the abnormal area will be looked at with a tube that has a lighted camera on one end (called a laryngoscopy) to check the size of the tumor and to look for any additional cancerous areas.
The tumor will be exposed with standard equipment after the teeth are protected with a dental guard. Using the robotic surgical system, the tumor will be removed.
Your affected lymph nodes will be surgically removed through your neck. The robotic system will not be used for that part of the surgery. The nerve that controls the shoulder, the blood vessel that brings blood back to the heart from the brain and neck, and the major muscle of the front of the neck will all be saved, unless the tumor in the lymph nodes has grown directly into those areas. A drain will be placed before the surgical wound is closed. The drain will usually be removed within a week after surgery.
Based on the results of surgery, you will receive adjuvant therapy (therapy after the surgery). For example, if your surgery does not remove enough of the cancer, you will be referred to receive radiation therapy. There will likely need to be a 1-2 week delay before you can receive radiation therapy. Your doctor will discuss this therapy with you in more detail, including the risks.
Length of Study:
The surgery will be stopped if the doctor thinks the tumor is too large to be removed with the robotic system. You will be taken off study if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits and data collection.
Follow-Up Visits:
Within 1-4 weeks after surgery (+/- 3 days):
- You will have a physical exam, including a cranial nerve exam of your tongue, palate, and facial nerves.
- You will have an MBS.
- You will meet with a speech pathologist.
- You will complete the questionnaires about your speech and swallowing function.
At 6 months (+/- 2 months), 12 months (+/- 2 months), and 24 months (+/- 6 months) after surgery:
- You will have an MBS.
- You will have a cranial nerve exam of your tongue, palate, and facial nerves.
- You will meet with a speech pathologist.
- You will complete the questionnaires about your speech and swallowing function.
As often as the doctor thinks it is needed for up to 5 years after surgery, the study staff will check your medical record to find out how you are doing and about any treatments and follow-up you have had.
This is an investigational study. The robotic surgical procedure (the daVinci Surgical System) is FDA approved and commercially available. The study doctor can explain how the surgery is designed to work.
Up to 150 participants will be enrolled in this study. All will be enrolled at MD Anderson.
- Conditions
- Oropharyngeal Cancer
- Being tested
- Transoral Robotic Surgery (TORS), Modified Barium Swallow (MBS), Questionnaires
- Keywords
- Oropharyngeal cancer, Oropharynx, Human papilloma virus, HPV positive, Squamous cell carcinoma, SCC, Transoral robotic surgery, TORS, Intuitive Surgical da Vinci Surgical System, Modified barium swallow, MBS, Questionnaires, Surveys, Speech and swallowing function
- Medical subject headings
- Oropharyngeal Neoplasms, Carcinoma, Squamous Cell, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral Robotic Surgery (TORS)Procedure or surgery
Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm.
Modified Barium Swallow (MBS)Procedure or surgery
Also called MBS
MBS performed at baseline and 1 - 4 weeks after surgery, and at 6 months, 12 months and 24 months.
QuestionnairesBehavioural
Also called Surveys
Questionnaires about speech and swallowing function completed at baseline, 1 - 4 weeks after surgery, and at 6 months, 12 months, and at 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Transoral Robotic Surgery (TORS) | Experimental | Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm. Functional assessment performed at pre-treatment, within 1-4 weeks post-op from TORS (before adjuvant therapy), and after completion of treatment at the following time points: 6 months (±2 months), 12 months (±2 months), and 24 months (±6 months). Functional measures include video-fluoroscopic examination of swallowing (modified barium swallow [MBS] study) with administration of the Performance Status Scale-Head and Neck (PSS-HN) and MD Anderson Dysphagia Inventory (MDADI) questionnaire. Receives: Procedure: Transoral Robotic Surgery (TORS); Procedure: Modified Barium Swallow (MBS); Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to local-regional recurrence (TTLRR)
Primary efficacy endpoint is time to local-regional recurrence (TTLRR). TTLRR measured from surgery (using minimally-invasive Transoral Robotic Surgery (TORS)) date to first date that local-regional recurrence disease is objectively documented or to last follow-up date if local-regional recurrence has not occurred during follow-up.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start23 Sep 2014
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Why it stopped: Another trial in the department directly competes for the the same patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael E. Kupferman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225496
- Sponsor's protocol ID
- 2013-0925
- Other IDs
- NCI-2014-02126
- Status last verified
- Dec 2017
- First submitted
- 22 Aug 2014
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Transoral Robotic Surgery With Adjuvant Therapy for Surgically Resectable HPV-positive Oropharyngeal Cancer
- ClinicalTrials.gov ID
- NCT02225496
- Acronym / sponsor ID
- 2013-0925
- Conditions
- Oropharyngeal Cancer
- Keywords
- Oropharyngeal cancer, Oropharynx, Human papilloma virus, HPV positive, Squamous cell carcinoma, SCC, Transoral robotic surgery, TORS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Another trial in the department directly competes for the the same patient population
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 23 Sep 2014 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 26 Aug 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.
Standard-of-care treatment options for oropharyngeal cancer often result in long-term side effects that interfere with normal quality of life. A minimally-invasive transoral robotic surgery (TORS) approach has been developed to operate on the disease site while affecting the surrounding tissue as little as possible. Researchers think that this approach may help to control the disease and avoid such long-term side effects.
The goal of this clinical research study is to learn if minimally-invasive transoral robotic surgery (TORS) can help to control HPV-positive oropharyngeal cancer. Transoral means through the mouth. The TORS approach is called the Intuitive Surgical da Vinci Surgical System.
Researchers also want to learn if this surgery affects participants' ability to speak and swallow.
Detailed description
Study Surgery:
If you are found to be eligible to take part in this study, you will be scheduled for surgery. You will receive general anesthesia to make you sleep during the procedure. You will be asked to sign a separate consent form that describes the anesthesia and its risks. If the doctor thinks it is needed, the abnormal area will be looked at with a tube that has a lighted camera on one end (called a laryngoscopy) to check the size of the tumor and to look for any additional cancerous areas.
The tumor will be exposed with standard equipment after the teeth are protected with a dental guard. Using the robotic surgical system, the tumor will be removed.
Your affected lymph nodes will be surgically removed through your neck. The robotic system will not be used for that part of the surgery. The nerve that controls the shoulder, the blood vessel that brings blood back to the heart from the brain and neck, and the major muscle of the front of the neck will all be saved, unless the tumor in the lymph nodes has grown directly into those areas. A drain will be placed before the surgical wound is closed. The drain will usually be removed within a week after surgery.
Based on the results of surgery, you will receive adjuvant therapy (therapy after the surgery). For example, if your surgery does not remove enough of the cancer, you will be referred to receive radiation therapy. There will likely need to be a 1-2 week delay before you can receive radiation therapy. Your doctor will discuss this therapy with you in more detail, including the risks.
Length of Study:
The surgery will be stopped if the doctor thinks the tumor is too large to be removed with the robotic system. You will be taken off study if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits and data collection.
Follow-Up Visits:
Within 1-4 weeks after surgery (+/- 3 days):
- You will have a physical exam, including a cranial nerve exam of your tongue, palate, and facial nerves.
- You will have an MBS.
- You will meet with a speech pathologist.
- You will complete the questionnaires about your speech and swallowing function.
At 6 months (+/- 2 months), 12 months (+/- 2 months), and 24 months (+/- 6 months) after surgery:
- You will have an MBS.
- You will have a cranial nerve exam of your tongue, palate, and facial nerves.
- You will meet with a speech pathologist.
- You will complete the questionnaires about your speech and swallowing function.
As often as the doctor thinks it is needed for up to 5 years after surgery, the study staff will check your medical record to find out how you are doing and about any treatments and follow-up you have had.
This is an investigational study. The robotic surgical procedure (the daVinci Surgical System) is FDA approved and commercially available. The study doctor can explain how the surgery is designed to work.
Up to 150 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transoral Robotic Surgery (TORS) | Experimental | Procedure: Transoral Robotic Surgery (TORS), Procedure: Modified Barium Swallow (MBS), Behavioral: QuestionnairesTransoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm. Functional assessment performed at pre-treatment, within 1-4 weeks post-op from TORS (before adjuvant therapy), and after completion of treatment at the following time points: 6 months (±2 months), 12 months (±2 months), and 24 months (±6 months). Functional measures include video-fluoroscopic examination of swallowing (modified barium swallow [MBS] study) with administration of the Performance Status Scale-Head and Neck (PSS-HN) and MD Anderson Dysphagia Inventory (MDADI) questionnaire. |
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 with a previously untreated, T1 or T2, N0-N2b transorally resectable (as determined by the treating surgeon), histologically proven HPV positive, squamous cell carcinoma (SCC) of the oropharynx.
- Eastern Cooperative Oncology Group (ECOG) PS 0-2.
- Age >/= 18 years.
- Negative serum pregnancy test in females of childbearing potential.
- Patients must sign a study-specific informed consent form prior to treatment.
Key exclusion criteria (6 listed)
- Evidence of distant metastases (below the clavicle) by clinical or radiographic examination.
- Evidence of any other primary cancers or metastases. Evidence of deep soft-tissue or bony invasion, which would preclude TMIS by clinical and/or radiographic exam.
- Contraindications to general anesthesia.
- Patients who have had chemotherapy or radiotherapy to the oropharynx prior to entering the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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 Surgery (TORS)Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm. | Procedure or surgery | Transoral Robotic Surgery (TORS) |
| Modified Barium Swallow (MBS)Also: MBSMBS performed at baseline and 1 - 4 weeks after surgery, and at 6 months, 12 months and 24 months. | Procedure or surgery | Transoral Robotic Surgery (TORS) |
| QuestionnairesAlso: SurveysQuestionnaires about speech and swallowing function completed at baseline, 1 - 4 weeks after surgery, and at 6 months, 12 months, and at 24 months. | Behavioural | Transoral Robotic Surgery (TORS) |
Primary outcome
Time to local-regional recurrence (TTLRR)
Time frame: 6 months after surgery
Primary efficacy endpoint is time to local-regional recurrence (TTLRR). TTLRR measured from surgery (using minimally-invasive Transoral Robotic Surgery (TORS)) date to first date that local-regional recurrence disease is objectively documented or to last follow-up date if local-regional recurrence has not occurred during follow-up.
Results and safety
The study was stopped early (reason given: Another trial in the department directly competes for the the same patient population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Michael E. Kupferman, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transoral Robotic Surgery (TORS), Modified Barium Swallow (MBS) and Questionnaires in people with Oropharyngeal Cancer, run by M.D. Anderson Cancer 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 6 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 15 Dec 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Another trial in the department directly competes for the the same patient population). 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?
Time to local-regional recurrence (TTLRR) (time frame: 6 months after surgery). 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 15 Dec 2017.