This trial is active, not recruiting.

Condition nasopharyngeal carcinoma
Treatments proton/photon radiotherapy, cisplatin, fluorouracil
Phase phase 2
Sponsor Massachusetts General Hospital
Collaborator Brigham and Women's Hospital
Start date October 2006
End date November 2016
Trial size 25 participants
Trial identifier NCT00592501, 05-089


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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
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

Secondary Outcomes

To determine the rate and pattern of locoregional tumor recurrence in this patient population that have received this treatment.
time frame: TBD

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Study of Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma
Principal investigator Annie W Chan, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.