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A Phase II Study of Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma

Phase 2
18 Years
Open (Enrolling)
Nasopharyngeal Carcinoma

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Trial Information

A Phase II Study of Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma

- 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

- 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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To test the hypothesis that reduction of radiation dose to normal tissue can reduce acute toxicity and increase treatment compliance to combined modality treatment.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Annie W Chan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

October 2006

Completion Date:

November 2014

Related Keywords:

  • Nasopharyngeal Carcinoma
  • proton radiation
  • photon radiation
  • 5-FU
  • cisplatin
  • Carcinoma
  • Nasopharyngeal Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617