Clinical trial NCT00592501: Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma
Official title: A Phase II Study of Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: proton radiation
photon radiation
5-FU
cisplatin
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Dana-Farber Cancer Institute
First posted: 2008-01-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

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 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

Primary outcomes:
measure: Number of Participants With Acute Toxicity
timeFrame: 54 days of chemoradiation treatment and 90 days after completion, up to 144 days total
measure: Participant Compliance Rate to Assigned Treatment Intervention
timeFrame: 2 years
measure: Sialometry to Evaluate Xerostomia (Dry Mouth)
timeFrame: Baseline and 2 years (24 months)
measure: Penetration-aspiration Scale to Evaluate Swallowing Function
timeFrame: Baseline and 12 months
measure: Serial Measurements of Maximal Inter-incisal Distance to Evaluate Trismus (Lockjaw)
timeFrame: Baseline and 2 years
measure: ChemoSensory Questionnaire (CSQ) to Evaluate Smell and Taste Function
timeFrame: 2 years
measure: Number of Participants With Speech Problems Assessed by Head and Neck Health Status Assessment Inventory (HNHSAI)
timeFrame: 2 years
measure: Health Related Quality-of-Life Outcomes Using Validated Quality-of-Life Instrument EORTC QLQ-C30
timeFrame: 2 years
measure: Health Related Quality-of-life Outcomes Using Validated Quality-of-life Instrument EORTC-QLQ-H&N
timeFrame: 2 years
Secondary outcomes:
measure: Rate and Pattern of Locoregional Tumor Recurrence
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Annie W Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: