Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Intervention: Proton/Photon Radiotherapy; Cisplatin; Fluorouracil
Intervention description: 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.
Intervention MeSH terms: Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: proton radiation; photon radiation; 5-FU; cisplatin

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
    

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