Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Annie W. Chan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592501
First received: December 28, 2007
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Nasopharyngeal Carcinoma
Radiation: Proton/Photon Radiotherapy
Drug: Cisplatin
Drug: Fluorouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the rate and pattern of locoregional tumor recurrence in this patient population that have received this treatment. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: October 2006
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Proton/Photon Radiotherapy
    Given once a day, five days a week, for seven weeks.
    Drug: Cisplatin
    Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.
    Drug: Fluorouracil
    Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy.
    Other Name: 5-FU
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592501

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Annie W Chan, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Annie W. Chan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592501     History of Changes
Other Study ID Numbers: 05-089
Study First Received: December 28, 2007
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
proton radiation
photon radiation
5-FU
cisplatin

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Carcinoma
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014