Squamous Cell Carcinoma of the Head and NeckPhase 4NCT01344356

Stereotactic Body Radiotherapy for Head and Neck Tumors

A Phase 4 study testing stereotactic body radiotherapy in people with Squamous Cell Carcinoma of the Head and Neck and Nasopharyngeal Carcinoma, run by Mercy Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Squamous Cell Carcinoma of the Head and Neck, Nasopharyngeal Carcinoma, Salivary Gland Cancer
What is being tested?: stereotactic body radiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: Jul 2008to May 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patient age > 18 years
Zubrod performance status of 0-3
Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma
Malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma
Signed study-specific consent form

Who cannot join

Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

St. John's Mercy Medical Center
St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors

This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors.

Read the detailed description

This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT:

Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection
Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group)
Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Conditions: Squamous Cell Carcinoma of the Head and Neck, Nasopharyngeal Carcinoma, Salivary Gland Cancer, Head and Neck Sarcoma, Paraganglioma of Head and Neck, Chordoma of Head and Neck
Being tested: stereotactic body radiotherapy
Keywords: stereotactic radiosurgery, head and neck tumors, squamous cell carcinoma of head and neck
Medical subject headings: Squamous Cell Carcinoma of Head and Neck, Nasopharyngeal Carcinoma, Salivary Gland Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

stereotactic body radiotherapyRadiation
14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
Stereotactic body radiotherapyRadiation
8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)

Study groups in NCT01344356
Study group	Role	What they receive
Benign Tumors	Other	Benign head and neck tumors will be treated with SBRT Receives: Radiation: stereotactic body radiotherapy
Malignant Tumors	Other	Malignant Head and Neck Tumors will be treated with SBRT. Receives: Radiation: Stereotactic body radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Local Control Rate
Complete or partial tumor response or stable disease
Measured: 5 years
Local Recurrence
Instances of progressive disease
Measured: 5 years
Complication Rate
Number of participants with any adverse event
Measured: 5 years

Secondary outcomes (1)

Overall Survival
Number of participants who are alive 5 years following treatment.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008May 2018

First posted29 Apr 2011 (estimated)
Study startJul 2008
Primary completionMay 2018
Study completionMay 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01344356
Sponsor's protocol ID: 08-046
Status last verified: Mar 2020
First submitted: 27 Apr 2011
Last updated: 10 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

All Squamous Cell Carcinoma of the Head and Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors
ClinicalTrials.gov ID: NCT01344356
Acronym / sponsor ID: 08-046
Conditions: Squamous Cell Carcinoma of the Head and Neck, Nasopharyngeal Carcinoma, Salivary Gland Cancer, Head and Neck Sarcoma, Paraganglioma of Head and Neck, Chordoma of Head and Neck
Keywords: stereotactic radiosurgery, head and neck tumors, squamous cell carcinoma of head and neck
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Mercy ResearchUniversity, hospital or other
Study start: Jul 2008
Primary completion: May 2018 (actual)
Study completion: May 2018 (actual)
First posted: 29 Apr 2011 (estimated)
Results: Posted 10 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors.

Detailed description

This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT:

Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection
Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group)
Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Benign Tumors	Other	Radiation: stereotactic body radiotherapyBenign head and neck tumors will be treated with SBRT
Malignant Tumors	Other	Radiation: Stereotactic body radiotherapyMalignant Head and Neck Tumors will be treated with SBRT.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient age > 18 years
Zubrod performance status of 0-3
Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma
Malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma
Signed study-specific consent form

Key exclusion criteria (2 listed)

Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

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
stereotactic body radiotherapy14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)	Radiation	Benign Tumors
Stereotactic body radiotherapy8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)	Radiation	Malignant Tumors

Primary outcome

Local Control Rate
Time frame: 5 years
Complete or partial tumor response or stable disease
Local Recurrence
Time frame: 5 years
Instances of progressive disease
Complication Rate
Time frame: 5 years
Number of participants with any adverse event

1 secondary outcome

Overall Survival
Time frame: 5 years

Results and safety

Results posted to the registry on 10 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Benign Tumors	1	1
Unrescectable Malignant Tumors	18	9

Primary outcome: Local Control Rate

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Benign Tumors n = 1	Malignant Tumors n = 6
Value	1	5

Population analysed: 12 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.

Primary outcome: Local Recurrence

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Benign Tumors n = 1	Malignant Tumors n = 6
Value	0	3

Population analysed: 12 patients did not have local recurrence rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.

Primary outcome: Complication Rate

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Benign Tumors n = 1	Unrescectable Malignant Tumors n = 9
Value	1	4

Population analysed: 9 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Benign Tumors	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Malignant Tumors	0 of 8 (0%)	5 of 8 (62.5%)	8 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Squamous Cell Carcinoma of the Head and Neck

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing stereotactic body radiotherapy in people with Squamous Cell Carcinoma of the Head and Neck and Nasopharyngeal Carcinoma, run by Mercy Research 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 2 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: finished, as of the sponsor's last update on 10 Apr 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Local Control Rate (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01344356.

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 Apr 2020.