Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Brigham and Women's Hospital Dana-Farber Cancer Institute
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00592501

Purpose

Photon beam radiation is the standard type of radiation used to treat nasopharyngeal carcinoma. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor and leaves the body through healthy tissue. Proton beam radiation has been shown to have the same effect on tumors as photon beam radiation but it enters the body, passes through healthy tissue, and encounters the tumor but then stops. This means less healthy tissue is affected by proton beam treatment than by photon beam treatment. The purpose of this study is to determine the effectiveness of proton beam radiation in treating nasopharyngeal cancer and reducing the acute and long-term side effects from the treatment. This study will also test to see if the sparing of the healthy tissue can improve quality of life

Condition	Intervention	Phase
Nasopharyngeal Carcinoma	Radiation: Proton/Photon Radiotherapy Drug: Cisplatin Drug: Fluorouracil	Phase II

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: Fluorouracil Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To test the hypothesis that reduction of radiation dose to normal tissue can reduce acute toxicity and increase treatment compliance to combined modality treatment. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To assess health related quality-of-life outcomes after proton radiotherapy for nasopharyngeal carcinoma using objective measurements and validated quality-of-life instruments. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the rate and pattern of locoregional tumor recurrence in this patient population that have received this treatment. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	October 2006
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Given once a day, five days a week, for seven weeks.

Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.

Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy.

Detailed Description:

Before beginning study treatment, participants will be asked to fill out a Quality of Life (QOL) questionnaires, a Speech Assessment, a ChemoSensory Questionnaire, a Patient Swallowing Diary, A Swallowing Study, Salivary Tests and a Trismus Assessment. Participants will need to go to the Massachusetts Eye and Ear Infirmary (MEEI) or Massachusetts General Hospital (MGH) for these tests.
Radiation therapy will be given once a day, five days a week, for seven weeks. This will be given as outpatient care at the Northeast Proton Therapy Center (proton component) and Massachusetts General Hospital (photon component).
During radiation treatments, participants will receive cisplatin intravenously once every three weeks. This three-week period is called a cycle of treatment.
After the completion of radiation, participants will receive cisplatin intravenously once every 4 weeks along with fluorouracil as a continuous infusion over 4 days starting on the day cisplatin is given, for three cycles.
Participants will have a physical exam and blood work drawn weekly to monitor their health.
An MR/CT scan of the head and neck will be done 2 months after the radiation treatment.
Follow-up visits will occur once every three months for 2 years, then once every 6 months during years 3-5, then annually. During these follow-up visits, participants will have the following tests and procedures: physical examination; blood work; chest CT scan and CT/MRI of the head and neck will be repeated once every 6 months during the first three years; swallow study; salivary study; QOL questionnaires; speech assessment; ChemoSensory Questionnaire; and Trismus Assessment.

Eligibility

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

Criteria

Inclusion Criteria:

Biopsy proven greater than or equal to T2b and/or node positive non-metastatic, squamous cell carcinoma of the nasopharynx, types WHO I-III.
No head and neck surgery of the primary tumor or lymph nodes except incisional or excisional biopsies.
Zubrod performance status 0-1 or Karnofsky 70 or above.
All patients must undergo pre-treatment evaluation of tumor extent and tumor measurement.
Nutritional and general physical condition must be considered compatible with the proposed chemoradiation treatment
Patients must have adequate platelet and renal function as outlined in protocol.
18 years of age or above.
No active alcohol addiction.
Women of childbearing potential must have a negative pregnancy test.

Exclusion Criteria:

Stage IVC or evidence of distant metastases
Previous irradiation for head and neck tumor
Patient is on other experimental therapeutic cancer treatment
Other malignancy except non-melanoma skin cancer or carcinomas of head and neck origin and have been controlled for at least 5 years.
Active untreated infection
Major medical or psychiatric illness
Prophylactic use of amifostine or pilocarpine
Pregnant or breast feeding women
Symptomatic peripheral neuropathy of grade 2 or greater by NCI CTCAE
Symptomatic altered hearing > grade 2 by CTCAE

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592501

Contacts

Contact: W. Annie Chan, MD

617-726-4214

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: W. Annie Chan, MD
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Roy B. Tishler, MD

Sponsors and Collaborators

Massachusetts General Hospital

Brigham and Women's Hospital

Dana-Farber Cancer Institute

Investigators

Principal Investigator:

W. Annie Chan, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( W. Annie Chan, MD )
Study ID Numbers:	05-089
Study First Received:	December 28, 2007
Last Updated:	December 28, 2007
ClinicalTrials.gov Identifier:	NCT00592501 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

proton radiation
photon radiation
5-FU
cisplatin

Study placed in the following topic categories:

Antimetabolites
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Nasopharyngeal Carcinoma
Immunologic Factors
Pharyngeal Neoplasms
Immunosuppressive Agents
Pharyngeal Diseases

Nasopharyngeal Neoplasms
Carcinoma
Cisplatin
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Fluorouracil
Stomatognathic Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Otorhinolaryngologic Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Pharyngeal Neoplasms
Nasopharyngeal Neoplasms
Neoplasms by Site
Cisplatin
Therapeutic Uses
Nasopharyngeal Diseases

Otorhinolaryngologic Diseases
Neoplasms by Histologic Type
Pharyngeal Diseases
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Fluorouracil
Stomatognathic Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009