Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma
|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.|
|ClinicalTrials.gov Identifier: NCT00592501|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2008
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Radiation: Proton/Photon Radiotherapy Drug: Cisplatin Drug: Fluorouracil||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma|
|Study Start Date :||October 2006|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
|Experimental: Proton/Photon Radiotherapy, Cisplatin, Fluorouracil||
Radiation: Proton/Photon Radiotherapy
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.
Other Name: 5-FU
- 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.
- Rate and pattern of locoregional tumor recurrence
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Annie W Chan, MD||Massachusetts General Hospital|