Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers - Full Text View

Sponsored by:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00797446

Purpose

You are being asked to take part in this study because you have cancer of the oropharynx (tonsillar pillar, tonsillar fossa, soft palate, and/or base of the tongue) and you are going to have proton beam radiotherapy (radiation treatment).

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

Protons may offer a unique advantage. It may be possible to design treatments where surrounding or non-tumor-overlapping tissues could be spared.

Condition	Intervention
Oropharyngeal Cancers	Radiation: Photon/Proton Beam Radiation Therapy

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Oropharyngeal Cancers

Further study details as provided by University of Florida:

Primary Outcome Measures:

Collect and analyze morbidity outcomes: incidence of xerostomia [ Time Frame: Every 4 months until final analysis ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Collect and analyze tumor control outcomes. [ Time Frame: When each patient has been followed for a minimum of 12 months and then again after 24 months. ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2006
Estimated Study Completion Date:	July 2056
Estimated Primary Completion Date:	July 2056 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Photon/Proton Beam Radiation Therapy: Experimental	Radiation: Photon/Proton Beam Radiation Therapy Standard of Care

Detailed Description:

If you take part in this study, you will be asked eight questions about dry mouth symptoms that you may have. Answering these questions will take less than 10 minutes. You will have the standard treatment for your type of cancer, which has been determined by your cancer doctor.

Patients are stratified:

Stage I (T1N0)- RT alone
Stage II (T2N0) - RT alone
Favorable Stage III (T1N1/T2N1)and selected IV (T1-T2 early N2b)with two or less LN and 2 or less cm diameter LN - RT alone
Unfavorable Stage III (T3N0) and selected IV (any T, N2c/N3) - RT + chemo

Treatment:

Photon/Proton radiation per standard of care

Chemo if indicated: CDDP 30 mg/m2 q week or CDDP 100 mg/m2 q 3 weeks at the discretion of medical oncologist

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 LN and 2 or less cm diameter LN
- Unfavorable stage III and selected stage IV (any T, N2c/N3)
Surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsies.
Zubrod performance status 0-1.
Pretreatment evaluation of tumor extent and tumor measurement.
Willing to follow instructions (e.g. avoid smoking/alcohol) and keep appointments.
Nutritional and general physical condition must be considered compatible with the proposed treatment.
Patients with unfavorable stage III or selected stage IV disease and scheduled to receive chemotherapy, should have a pretreatment WBC equal to or greater than 4000 and a platelet count of equal to or greater than 100,000; patients must have adequate renal function as documented by creatinine clearance equal to or greater than 60 ml/min (actual or calculated by the Cockroft-Gault method).
Signed informed consent

Exclusion Criteria:

Evidence of distant metastasis.
Previous irradiation for head and neck cancer.
Prior chemotherapy less than or equal to 6 months prior to study entry.
Other malignancy that has not been disease-free for at least 5 years, except non-melanoma skin cancer.
Active untreated infection.
Major medical, addictive and/or psychiatric illness that would interfere with completion of treatment or follow-up or the consent process.
Pregnant or breast-feeding women, or women and men of child-producing potential not willing to use contraception during treatment and for at least 3 months thereafter.
Other therapeutic treatment for head and neck cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797446

Contacts

Contact: Amanda D Prince, RN	(904)588-1298	aprince@floridaproton.org
Contact: Cindy L Carroll	(904)588-1288	ccarroll@floridaproton.org

Locations

United States, Florida
University of Florida Proton Therapy Institute	Recruiting
Jacksonville, Florida, United States, 32206
Contact: Amanda D Prince, RN 904-588-1298 aprince@floridaproton.org
Contact: Cindy L Carroll (904)588-1288 ccarroll@floridaproton.org
Principal Investigator: Robert S Malyapa, MD,PhD

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Robert S Malyapa, MD, PhD

University of Florida Proton Therapy Institute

More Information

Responsible Party:	University of Florida Proton Therapy Institute ( Robert S. Malyapa, MD, PhD )
Study ID Numbers:	UFPTI 0601-OP01
Study First Received:	November 24, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00797446
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Oropharyngeal

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Pharyngeal Neoplasms

Stomatognathic Diseases
Pharyngeal Diseases
Oropharyngeal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009