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Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00592501
First Posted: January 14, 2008
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Annie W. Chan, MD, Massachusetts General Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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 Annie W. Chan, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Acute Toxicity [ Time Frame: 8 years ]
    Acute toxicity related to the study intervention.

  • Health related quality-of-life outcomes using objective measurements and validated quality-of-life instruments. [ Time Frame: 2 years ]
    Health related quality of life outcomes evaluated by validated measures. Sialometry is used to evaluate xerostomia (dry mouth). Videofluoroscopic measurements are used to evaluate swallowing function. Serial measures of the changes of the maximal inter-incisal distance in the vertical opening, right lateral, and left lateral jaw movements are used to evaluate trismus (lockjaw). The ChemoSensory Questionnaire (CSQ) is used to evaluate smell and taste function. Speech is assessed with the Speech Assessment/Head and Neck Health Status Assessment Inventory (HNHSAI). General quality of life is measured with the European organization for research and treatment of cancer (EORTC) quality of life questionnaires (QLQ) for head and neck (H&N) (EORTC-QLQ-H&N) and the EORTC QLQ-C30 (cancer 30).

  • Treatment Compliance [ Time Frame: 2 years ]
    The participant compliance rate to the assigned intervention.


Secondary Outcome Measures:
  • Rate and pattern of locoregional tumor recurrence

Enrollment: 25
Study Start Date: October 2006
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton/Photon Radiotherapy, Cisplatin, Fluorouracil 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Annie W. Chan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592501     History of Changes
Other Study ID Numbers: 05-089
First Submitted: December 28, 2007
First Posted: January 14, 2008
Last Update Posted: April 18, 2017
Last Verified: April 2017

Keywords provided by Annie W. Chan, MD, Massachusetts General Hospital:
proton radiation
photon radiation
5-FU
cisplatin

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