Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma
NCT ID: NCT00592501
Last Updated: 2021-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2006-10-31
2019-04-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Proton/Photon Radiotherapy, Cisplatin, Fluorouracil
Proton/Photon Radiotherapy
Given once a day, five days a week, for seven weeks.
Cisplatin
Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.
Fluorouracil
Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy.
Interventions
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Proton/Photon Radiotherapy
Given once a day, five days a week, for seven weeks.
Cisplatin
Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.
Fluorouracil
Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Annie W. Chan, MD
Annie W. Chan, MD
Principal Investigators
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Annie W Chan, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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05-089
Identifier Type: -
Identifier Source: org_study_id