Head and Neck CarcinomaNCT01627093
Medical Data Collection of Patients With Head and Neck Cancer Treated With Proton Therapy
An observational study of Head and Neck Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial collects medical information from patients with head and neck cancer that have received or are scheduled to receive proton therapy. Collecting and analyzing medical information from patients may provide information on the outcomes and treatment related side effects of proton therapy for head and neck cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Medical Chart Review and Questionnaire Administration
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2012to 30 Apr 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients documented to have head and neck cancer treated with proton therapy at MD Anderson Cancer Center in Houston, Texas (MDACC) from January 1, 2008 through April 30, 2012, and patients who receive treatment from May 1, 2012 through December 31, 2018
Who may be able to join
- Patients documented to have head and neck cancer treated with proton therapy at MDACC from January 1, 2008 through April 30, 2012 and patients who receive treatment from May 1, 2012 through December 31, 2018
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies
This trial collects medical information from patients with head and neck cancer that have received or are scheduled to receive proton therapy. Collecting and analyzing medical information from patients may provide information on the outcomes and treatment related side effects of proton therapy for head and neck cancer and help doctors improve therapy for future patients with head and neck cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the outcomes in patients who have received treatment for their head and neck malignancy with proton radiation therapy.
OUTLINE:
Patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. Patients also have their medical records reviewed.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Medical Chart Review, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Chart ReviewOther
Also called Chart Review
Review of medical records
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaire, medical chart review) | Patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. Patients also have their medical records reviewed. Receives: Other: Medical Chart Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival analysis of proton therapy for head and neck malignancies
Retrospective chart analysis will be performed on all patients documented to have head and neck cancer, treated with Proton Therapy at MDACC from January 1, 2008 through April 30, 2012. Prospective chart analysis will be performed on head and neck cancer patients currently being treated at MD Anderson Cancer Center beginning May 1, 2012 through December 31, 2018. Overall survival estimated using Kaplan-Meier method. Cox proportional hazards regression used to explore predictors of time-to-event outcomes. Mann-Whitney test used to compare continuous parameters between temporal cohorts.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study start6 Jan 2012
- Primary completion30 Apr 2032 (estimated)
- Study completion30 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 450 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
- Steven J Frank, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627093
- Sponsor's protocol ID
- PA11-0803
- Other IDs
- NCI-2020-00578, PA11-0803
- Status last verified
- Oct 2026
- First submitted
- 21 Jun 2012
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies
- ClinicalTrials.gov ID
- NCT01627093
- Acronym / sponsor ID
- PA11-0803
- Conditions
- Head and Neck Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Jan 2012 (actual)
- Primary completion
- 30 Apr 2032 (estimated)
- Study completion
- 30 Apr 2032 (estimated)
- First posted
- 25 Jun 2012 (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.
This trial collects medical information from patients with head and neck cancer that have received or are scheduled to receive proton therapy. Collecting and analyzing medical information from patients may provide information on the outcomes and treatment related side effects of proton therapy for head and neck cancer and help doctors improve therapy for future patients with head and neck cancer.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the outcomes in patients who have received treatment for their head and neck malignancy with proton radiation therapy.
OUTLINE:
Patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. Patients also have their medical records reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire, medical chart review) | – | Other: Medical Chart Review, Other: Questionnaire AdministrationPatients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. Patients also have their medical records reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients documented to have head and neck cancer treated with proton therapy at MD Anderson Cancer Center in Houston, Texas (MDACC) from January 1, 2008 through April 30, 2012, and patients who receive treatment from May 1, 2012 through December 31, 2018
Key inclusion criteria (1 listed)
- Patients documented to have head and neck cancer treated with proton therapy at MDACC from January 1, 2008 through April 30, 2012 and patients who receive treatment from May 1, 2012 through December 31, 2018
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Medical Chart ReviewAlso: Chart ReviewReview of medical records | Other | Observational (questionnaire, medical chart review) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (questionnaire, medical chart review) |
Primary outcome
Overall survival analysis of proton therapy for head and neck malignancies
Time frame: 7 years
Retrospective chart analysis will be performed on all patients documented to have head and neck cancer, treated with Proton Therapy at MDACC from January 1, 2008 through April 30, 2012. Prospective chart analysis will be performed on head and neck cancer patients currently being treated at MD Anderson Cancer Center beginning May 1, 2012 through December 31, 2018. Overall survival estimated using Kaplan-Meier method. Cox proportional hazards regression used to explore predictors of time-to-event outcomes. Mann-Whitney test used to compare continuous parameters between temporal cohorts.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 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.
Steven J Frank 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?
An observational study of 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 1 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival analysis of proton therapy for head and neck malignancies (time frame: 7 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 7 Oct 2026.