Oropharyngeal CancersOP01NCT00797446

Photon/Proton Radiation Therapy for Oropharyngeal Cancers

An observational study of Oropharyngeal Cancers, run by University of Florida at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Oropharyngeal Cancers
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Sep 2007to Jul 2015
Phase: Observational
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

Study population: Patients in the Radiation Oncology Clinic

Who may be able to join

Biopsy-proven squamous cell carcinoma of oropharynx (tonsillar pillars, tonsillar fossa, soft palate, base of tongue).
Stage-grouping:
Stage I (T1N0)
Stage II (T2N0)
Favorable Stage III (T1N1/T2N1) and selected stage IV (T1-T2 early N2b)2 or less lymph node and 2 or less cm diameter lymph node
Unfavorable stage III and selected stage IV (any T, N2c/N3)
Surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsies.
Will receive treatment with proton radiation.

Who cannot join

Evidence of distant metastasis.
Previous irradiation for head and neck cancer.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206

Other trials in United States

About this study

Official title: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers

Read the detailed description

This is an outcomes study and is designed to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

Conditions: Oropharyngeal Cancers
Keywords: Oropharyngeal, cancer, proton, radiation, outcomes
Medical subject headings: Oropharyngeal Neoplasms, Neoplasms

What participants receive

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

Study groups in NCT00797446
Study group	Role	What they receive
Photon/Proton Radiation Therapy		Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

What is being measured

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

Collect and analyze morbidity outcomes: incidence of xerostomia
Measured: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary outcomes (1)

Collect and analyze tumor control outcomes.
Measured: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Timeline

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

Sep 2007Jul 2015

First posted25 Nov 2008 (estimated)
Study startSep 2007
Primary completionJul 2015
Study completionJul 2015

Why it stopped: Slow enrollment, feasibility issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Oropharyngeal CancersStudies of the same condition, open and under way.
More trials run by University of FloridaThe 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: Prospective
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00797446
Sponsor's protocol ID: UFPTI 0601-OP01
Acronym: OP01
Status last verified: Feb 2017
First submitted: 24 Nov 2008
Last updated: 7 Feb 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Parsons JT, Mendenhall WM, Stringer SP, Amdur RJ, Hinerman RW, Villaret DB, Moore-Higgs GJ, Greene BD, Speer TW, Cassisi NJ, Million RR. Squamous cell carcinoma of the oropharynx: surgery, radiation therapy, or both. Cancer. 2002 Jun 1;94(11):2967-80. doi: 10.1002/cncr.10567.
PubMed 12115386
Mendenhall WM, Amdur RJ, Stringer SP, Villaret DB, Cassisi NJ. Radiation therapy for squamous cell carcinoma of the tonsillar region: a preferred alternative to surgery? J Clin Oncol. 2000 Jun;18(11):2219-25. doi: 10.1200/JCO.2000.18.11.2219.
PubMed 10829041
Ojiri H, Mendenhall WM, Stringer SP, Johnson PL, Mancuso AA. Post-RT CT results as a predictive model for the necessity of planned post-RT neck dissection in patients with cervical metastatic disease from squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):420-8. doi: 10.1016/s0360-3016(01)02603-7.
PubMed 11872288
Mendenhall WM, Villaret DB, Amdur RJ, Hinerman RW, Mancuso AA. Planned neck dissection after definitive radiotherapy for squamous cell carcinoma of the head and neck. Head Neck. 2002 Nov;24(11):1012-8. doi: 10.1002/hed.10187.
PubMed 12410537
Doweck I, Robbins KT, Mendenhall WM, Hinerman RW, Morris C, Amdur R. Neck level-specific nodal metastases in oropharyngeal cancer: is there a role for selective neck dissection after definitive radiation therapy? Head Neck. 2003 Nov;25(11):960-7. doi: 10.1002/hed.10315.
PubMed 14603457
Lefebvre JL, Chevalier D, Luboinski B, Kirkpatrick A, Collette L, Sahmoud T. Larynx preservation in pyriform sinus cancer: preliminary results of a European Organization for Research and Treatment of Cancer phase III trial. EORTC Head and Neck Cancer Cooperative Group. J Natl Cancer Inst. 1996 Jul 3;88(13):890-9. doi: 10.1093/jnci/88.13.890.
PubMed 8656441
Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. doi: 10.1056/NEJM199806183382503.
PubMed 9632446
Pignon JP, Hill C. Meta-analyses of randomised clinical trials in oncology. Lancet Oncol. 2001 Aug;2(8):475-82. doi: 10.1016/S1470-2045(01)00453-3.
PubMed 11905723
Denis F, Garaud P, Bardet E, Alfonsi M, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Calais G. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant radiochemotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004 Jan 1;22(1):69-76. doi: 10.1200/JCO.2004.08.021. Epub 2003 Dec 2.
PubMed 14657228
Mendenhall WM, Parsons JT, Million RR, Cassisi NJ, Devine JW, Greene BD. A favorable subset of AJCC stage IV squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 1984 Oct;10(10):1841-3. doi: 10.1016/0360-3016(84)90259-1. No abstract available.
PubMed 6490417
Mendenhall WM, Amdur RJ, Stringer SP, Villaret DB, Cassisi NJ. Stratification of stage IV SCC of the oropharynx. Head Neck. 2000 Sep;22(6):626-8. doi: 10.1002/1097-0347(200009)22:63.0.co;2-9. No abstract available.
PubMed 10941166
Mancuso AA, Mukherji SK, Schmalfuss I, Mendenhall W, Parsons J, Pameijer F, Hermans R, Kubilis P. Preradiotherapy computed tomography as a predictor of local control in supraglottic carcinoma. J Clin Oncol. 1999 Feb;17(2):631-7. doi: 10.1200/JCO.1999.17.2.631.
PubMed 10080608
Mendenhall WM, Parsons JT, Mancuso AA, Pameijer FJ, Stringer SP, Cassisi NJ. Definitive radiotherapy for T3 squamous cell carcinoma of the glottic larynx. J Clin Oncol. 1997 Jun;15(6):2394-402. doi: 10.1200/JCO.1997.15.6.2394.
PubMed 9196155
Cooper JS, Fu K, Marks J, Silverman S. Late effects of radiation therapy in the head and neck region. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1141-64. doi: 10.1016/0360-3016(94)00421-G.
PubMed 7713779
Korsten MA, Rosman AS, Fishbein S, Shlein RD, Goldberg HE, Biener A. Chronic xerostomia increases esophageal acid exposure and is associated with esophageal injury. Am J Med. 1991 Jun;90(6):701-6.
PubMed 2042685

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

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All Oropharyngeal Cancers trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers
ClinicalTrials.gov ID: NCT00797446
Acronym / sponsor ID: OP01 / UFPTI 0601-OP01
Conditions: Oropharyngeal Cancers
Keywords: Oropharyngeal, cancer, proton, radiation, outcomes
Study type: Observational
Recruitment status: TerminatedReason stopped: Slow enrollment, feasibility issues
Enrolment: 10 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: Sep 2007
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 25 Nov 2008 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Photon/Proton Radiation Therapy	–	–Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients in the Radiation Oncology Clinic

Key inclusion criteria (8 listed)

Biopsy-proven squamous cell carcinoma of oropharynx (tonsillar pillars, tonsillar fossa, soft palate, base of tongue).
Stage-grouping:
Surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsies.
Will receive treatment with proton radiation.

Key exclusion criteria (2 listed)

Evidence of distant metastasis.
Previous irradiation for head and neck cancer.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Collect and analyze morbidity outcomes: incidence of xerostomia
Time frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

1 secondary outcome

Collect and analyze tumor control outcomes.
Time frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Results and safety

The study was stopped early (reason given: Slow enrollment, feasibility issues). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
Background: PubMed 12115386Parsons JT, Mendenhall WM, Stringer SP, Amdur RJ, Hinerman RW, Villaret DB, Moore-Higgs GJ, Greene BD, Speer TW, Cassisi NJ, Million RR. Squamous cell carcinoma of the oropharynx: surgery, radiation therapy, or both. Cancer. 2002 Jun 1;94(11):2967-80. doi: 10.1002/cncr.10567.
Background: PubMed 10829041Mendenhall WM, Amdur RJ, Stringer SP, Villaret DB, Cassisi NJ. Radiation therapy for squamous cell carcinoma of the tonsillar region: a preferred alternative to surgery? J Clin Oncol. 2000 Jun;18(11):2219-25. doi: 10.1200/JCO.2000.18.11.2219.
Background: PubMed 11872288Ojiri H, Mendenhall WM, Stringer SP, Johnson PL, Mancuso AA. Post-RT CT results as a predictive model for the necessity of planned post-RT neck dissection in patients with cervical metastatic disease from squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):420-8. doi: 10.1016/s0360-3016(01)02603-7.
Background: PubMed 12410537Mendenhall WM, Villaret DB, Amdur RJ, Hinerman RW, Mancuso AA. Planned neck dissection after definitive radiotherapy for squamous cell carcinoma of the head and neck. Head Neck. 2002 Nov;24(11):1012-8. doi: 10.1002/hed.10187.
Background: PubMed 14603457Doweck I, Robbins KT, Mendenhall WM, Hinerman RW, Morris C, Amdur R. Neck level-specific nodal metastases in oropharyngeal cancer: is there a role for selective neck dissection after definitive radiation therapy? Head Neck. 2003 Nov;25(11):960-7. doi: 10.1002/hed.10315.
Background: PubMed 8656441Lefebvre JL, Chevalier D, Luboinski B, Kirkpatrick A, Collette L, Sahmoud T. Larynx preservation in pyriform sinus cancer: preliminary results of a European Organization for Research and Treatment of Cancer phase III trial. EORTC Head and Neck Cancer Cooperative Group. J Natl Cancer Inst. 1996 Jul 3;88(13):890-9. doi: 10.1093/jnci/88.13.890.
Background: PubMed 9632446Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. doi: 10.1056/NEJM199806183382503.
Background: PubMed 11905723Pignon JP, Hill C. Meta-analyses of randomised clinical trials in oncology. Lancet Oncol. 2001 Aug;2(8):475-82. doi: 10.1016/S1470-2045(01)00453-3.
Background: PubMed 14657228Denis F, Garaud P, Bardet E, Alfonsi M, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Calais G. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant radiochemotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004 Jan 1;22(1):69-76. doi: 10.1200/JCO.2004.08.021. Epub 2003 Dec 2.
Background: PubMed 6490417Mendenhall WM, Parsons JT, Million RR, Cassisi NJ, Devine JW, Greene BD. A favorable subset of AJCC stage IV squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 1984 Oct;10(10):1841-3. doi: 10.1016/0360-3016(84)90259-1. No abstract available.
Background: PubMed 10941166Mendenhall WM, Amdur RJ, Stringer SP, Villaret DB, Cassisi NJ. Stratification of stage IV SCC of the oropharynx. Head Neck. 2000 Sep;22(6):626-8. doi: 10.1002/1097-0347(200009)22:63.0.co;2-9. No abstract available.
Background: PubMed 10080608Mancuso AA, Mukherji SK, Schmalfuss I, Mendenhall W, Parsons J, Pameijer F, Hermans R, Kubilis P. Preradiotherapy computed tomography as a predictor of local control in supraglottic carcinoma. J Clin Oncol. 1999 Feb;17(2):631-7. doi: 10.1200/JCO.1999.17.2.631.
Individual participant dataSharing planned: Undecided

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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.

Roi Dagan, MD, MS principal investigator

University of Florida

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 Oropharyngeal Cancers, run by University of Florida 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 8 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: stopped early, as of the sponsor's last update on 7 Feb 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.

Are results available for this study?

The study was stopped early (reason given: Slow enrollment, feasibility issues). 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?

Collect and analyze morbidity outcomes: incidence of xerostomia (time frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months). 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 NCT00797446, which also lists 23 linked publications.

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 Feb 2017.