Recurrent Head and Neck CarcinomaPhase 2NCT03164460
Stereotactic Body Radiation Therapy or Intensity Modulated Radiation/Proton Therapy in Treating Patients With Recurrent Head and Neck Cancer
A Phase 2 study testing Intensity-Modulated Radiation Therapy, Proton Radiation and Stereotactic Body Radiation Therapy in people with Recurrent Head and Neck Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Carcinoma
- What is being tested?
- Intensity-Modulated Radiation Therapy, Proton Radiation and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 31 May 2027
- 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 histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer
- Not eligible for surgery for recurrence or poor surgical candidate
- Gross disease apparent on imaging (magnetic resonance imaging [MRI] or computed tomography [CT])
- 1-3 sites of recurrence (< 60 cc per site, total volume < 100 cc)
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
- Negative pregnancy test for women of child bearing potential
Who cannot join
- Patients who are pregnant or breast feeding
- Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
- a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
- b) No myocardial infarction within 3 months of registration
- Widely metastatic disease (oligometastatic disease acceptable)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomized Trial of Stereotactic Onco-Ablative Reirradiation Versus Conventionally Fractionated Conformal Radiotherapy for Patients With Small Inoperable Head and Neck Tumors (SOAR-HN)
This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the 2-year rate of Common Terminology Criteria for Adverse Events (CTCAE)-4.0 grade 3 or higher toxicity at 2 years between the two treatment arms.
SECONDARY OBJECTIVES:
- To compare the 2-year locoregional failure free survival (LFFS) in patients being treated with reirradiation with either stereotactic ablative radiotherapy (SBRT) versus intensity modulated radiation therapy/intensity modulated proton therapy (IMRT/IMPT).
II. To determine if there is any difference in local control, progression-free survival, and overall survival between the two arms.
III. To compare toxicity using Common Terminology Criteria for Adverse Events (CTCAE)-4.0 and Performance Status Scale-HN (Head and Neck).
IV. To compare patient reported outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI), MD Anderson Dysphagia Inventory (MDADI), Functional Assessment of Cancer Therapy (FACT)-HN, ACT-HN Symptom Index (FACT-HNSI), MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT), for skull base only, Anterior Skull BASE Questionnaire (ASBQ), for skull base only, Brief Fatigue Inventory (BFI), Telephone Interview for Cognitive Status (TICS), Performance Status Scale For Head and Neck Cancer Patients (PSS-HN), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem version (V)2.0 (WPAI:SHP), and University of Michigan Xerostomia-Related Quality of Life Scale, Xerostomia and Health Questionnaire (European Quality of Life Five Dimension Three Level [EQ-5D-3L]).
- Quality-Adjusted-Life-Years (QALY) comparison between IMPT and IMRT. VI. Compare cost-benefit economic analysis of treatment. VII. Perform dosimetric analysis and compare correlates of critical structures.
EXPLORATORY OBJECTIVES:
- To assess potential differences between patients on study and patients who were considered eligible for randomized, were randomized to a treatment arm, but may have dropped out of the study for other reasons after being randomized to; or were denied insurance coverage for the treatment arm she/he was randomized.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients undergo SBRT every other day for a total of 5 treatments.
GROUP II: Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.
After completion of study treatment, patients are followed up at 2-3 months, every 3 months for 1 year, and then every 3-4 months for up to 2 years.
- Conditions
- Recurrent Head and Neck Carcinoma
- Being tested
- Intensity-Modulated Radiation Therapy, Proton Radiation, Stereotactic Body Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-Modulated Radiation TherapyRadiation
Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy
Undergo IMRT/IMPT
Proton RadiationRadiation
Also called Radiation, Charged Particles-Protons
Undergo IMRT/IMPT
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Group I (SBRT) | Experimental | Patients undergo SBRT every other day for a total of 5 treatments. Receives: Radiation: Stereotactic Body Radiation Therapy |
| Group II (IMRT/IMPT) | Experimental | Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments. Receives: Radiation: Intensity-Modulated Radiation Therapy; Radiation: Proton Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3+ toxicity (Tox3+) assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Will use the methods of Gooley et al. to estimate the cumulative incidence of Tox3+, as well as competing-risk regression to model cumulative incidence of Tox3+ while treating death not related to Tox3+ as a competing event. The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between patient groups. The chi-square test or the Fisher's exact test will be applied to evaluate the association between two categorical variables. Logistic regression models will be used to evaluate the effects of the important patient clinical factors including treatment on TOX3+.
Measured: At 2 years
Secondary outcomes (7)
Local control defined as absence of local failure
The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between patient groups. The chi-square test or the Fisher's exact test will be applied to evaluate the association between two categorical variables. Logistic regression models will be used to evaluate the effects of the important patient clinical factors including treatment on TOX3+.
Measured: Up to 2 years
Local failure free survival (LFFS) defined as failure (recurrence or progression) within the prescribed radiation field, including failure within 2 cm of the radiation field
Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Proportional hazards regression may be employed for multivariate analysis on time-to-event outcomes.
Measured: From treatment initiation until local failure or death from any cause, assessed at 2 years
Incidence of acute grade 3 or higher toxicity assessed by CTCAE
The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between patient groups. The chi-square test or the Fisher's exact test will be applied to evaluate the association between two categorical variables. Logistic regression models will be used to evaluate the effects of the important patient clinical factors including treatment on TOX3+.
Measured: Up to 90 days after completion of radiation therapy
Incidence of late grade 3 or higher toxicity assessed by CTCAE
The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between patient groups. The chi-square test or the Fisher's exact test will be applied to evaluate the association between two categorical variables. Logistic regression models will be used to evaluate the effects of the important patient clinical factors including treatment on TOX3+.
Measured: 90 days up to 2 years
Progression free survival (PFS)
PFS event is defined as an LFFS event, or occurrence, recurrence or progression of distant metastases. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Proportional hazards regression may be employed for multivariate analysis on time-to-event outcomes.
Measured: From treatment initiation until an LFFS event, or occurrence, recurrence, or progression of distant metastases, whichever occurs first, assessed up to 2 years
Overall survival
Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Proportional hazards regression may be employed for multivariate analysis on time-to-event outcomes.
Measured: From treatment initiation until time to death from any cause, assessed up to 2 years
Patient reported outcomes (PROs)
Generalized linear models for the repeated measures analysis will be performed to assess the change in PROs overtime with important covariates including treatment in the models.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start22 May 2017
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Why it stopped: PI Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Head and Neck CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jack Phan, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164460
- Sponsor's protocol ID
- 2016-1065
- Other IDs
- NCI-2018-01190, 2016-1065
- Status last verified
- Aug 2026
- First submitted
- 22 May 2017
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial of Stereotactic Onco-Ablative Reirradiation Versus Conventionally Fractionated Conformal Radiotherapy for Patients With Small Inoperable Head and Neck Tumors (SOAR-HN)
- ClinicalTrials.gov ID
- NCT03164460
- Acronym / sponsor ID
- 2016-1065
- Conditions
- Recurrent Head and Neck Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI Request
- Enrolment
- 68 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 May 2017 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 23 May 2017 (actual)
- 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.
This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.
Detailed description
PRIMARY OBJECTIVES:
- To compare the 2-year rate of Common Terminology Criteria for Adverse Events (CTCAE)-4.0 grade 3 or higher toxicity at 2 years between the two treatment arms.
SECONDARY OBJECTIVES:
- To compare the 2-year locoregional failure free survival (LFFS) in patients being treated with reirradiation with either stereotactic ablative radiotherapy (SBRT) versus intensity modulated radiation therapy/intensity modulated proton therapy (IMRT/IMPT).
II. To determine if there is any difference in local control, progression-free survival, and overall survival between the two arms.
III. To compare toxicity using Common Terminology Criteria for Adverse Events (CTCAE)-4.0 and Performance Status Scale-HN (Head and Neck).
IV. To compare patient reported outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI), MD Anderson Dysphagia Inventory (MDADI), Functional Assessment of Cancer Therapy (FACT)-HN, ACT-HN Symptom Index (FACT-HNSI), MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT), for skull base only, Anterior Skull BASE Questionnaire (ASBQ), for skull base only, Brief Fatigue Inventory (BFI), Telephone Interview for Cognitive Status (TICS), Performance Status Scale For Head and Neck Cancer Patients (PSS-HN), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem version (V)2.0 (WPAI:SHP), and University of Michigan Xerostomia-Related Quality of Life Scale, Xerostomia and Health Questionnaire (European Quality of Life Five Dimension Three Level [EQ-5D-3L]).
- Quality-Adjusted-Life-Years (QALY) comparison between IMPT and IMRT. VI. Compare cost-benefit economic analysis of treatment. VII. Perform dosimetric analysis and compare correlates of critical structures.
EXPLORATORY OBJECTIVES:
- To assess potential differences between patients on study and patients who were considered eligible for randomized, were randomized to a treatment arm, but may have dropped out of the study for other reasons after being randomized to; or were denied insurance coverage for the treatment arm she/he was randomized.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients undergo SBRT every other day for a total of 5 treatments.
GROUP II: Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.
After completion of study treatment, patients are followed up at 2-3 months, every 3 months for 1 year, and then every 3-4 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (SBRT) | Experimental | Radiation: Stereotactic Body Radiation TherapyPatients undergo SBRT every other day for a total of 5 treatments. |
| Group II (IMRT/IMPT) | Experimental | Radiation: Intensity-Modulated Radiation Therapy, Radiation: Proton RadiationPatients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer
- Not eligible for surgery for recurrence or poor surgical candidate
- Gross disease apparent on imaging (magnetic resonance imaging [MRI] or computed tomography [CT])
- 1-3 sites of recurrence (< 60 cc per site, total volume < 100 cc)
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
Key exclusion criteria (5 listed)
- Patients who are pregnant or breast feeding
- Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
- Widely metastatic disease (oligometastatic disease acceptable)
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 |
|---|---|---|
| Intensity-Modulated Radiation TherapyAlso: IMRT, Intensity Modulated RT, Intensity-Modulated RadiotherapyUndergo IMRT/IMPT | Radiation | Group II (IMRT/IMPT) |
| Proton RadiationAlso: Radiation, Charged Particles-ProtonsUndergo IMRT/IMPT | Radiation | Group II (IMRT/IMPT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Group I (SBRT) |
Primary outcome
Incidence of grade 3+ toxicity (Tox3+) assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: At 2 years
Will use the methods of Gooley et al. to estimate the cumulative incidence of Tox3+, as well as competing-risk regression to model cumulative incidence of Tox3+ while treating death not related to Tox3+ as a competing event. The student t-test or the Wilcoxon rank sum test will be used to compare continuous variables between patient groups. The chi-square test or the Fisher's exact test will be applied to evaluate the association between two categorical variables. Logistic regression models will be used to evaluate the effects of the important patient clinical factors including treatment on TOX3+.
7 secondary outcomes
Local control defined as absence of local failure
Time frame: Up to 2 years
Local failure free survival (LFFS) defined as failure (recurrence or progression) within the prescribed radiation field, including failure within 2 cm of the radiation field
Time frame: From treatment initiation until local failure or death from any cause, assessed at 2 years
Incidence of acute grade 3 or higher toxicity assessed by CTCAE
Time frame: Up to 90 days after completion of radiation therapy
Incidence of late grade 3 or higher toxicity assessed by CTCAE
Time frame: 90 days up to 2 years
Progression free survival (PFS)
Time frame: From treatment initiation until an LFFS event, or occurrence, recurrence, or progression of distant metastases, whichever occurs first, assessed up to 2 years
Overall survival
Time frame: From treatment initiation until time to death from any cause, assessed up to 2 years
Patient reported outcomes (PROs)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- MD Anderson Cancer CenterLink 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.
Jack Phan 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 Intensity-Modulated Radiation Therapy, Proton Radiation and Stereotactic Body Radiation Therapy in people with Recurrent Head and Neck Carcinoma, 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 6 inclusion and 5 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: paused, as of the sponsor's last update on 10 Aug 2026. 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?
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?
Incidence of grade 3+ toxicity (Tox3+) assessed by Common Terminology Criteria for Adverse Events (CTCAE) (time frame: At 2 years). 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 Aug 2026.