Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592501
• Other study ID #: 05-089
• Status: Completed
• Phase: Phase 2
• Start date: October 2006
• Est. completion date: April 2019

Study information

• Verified date: October 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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.
• Fluorouracil
Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Acute Toxicity	Acute toxicities are side affects that occur during treatment and 90 days after completion.	54 days of chemoradiation treatment and 90 days after completion, up to 144 days total
Primary	Participant Compliance Rate to Assigned Treatment Intervention		2 years
Primary	Sialometry to Evaluate Xerostomia (Dry Mouth)	Sialometry is a measure of saliva flow. The normal daily production of saliva varies between 0.5 and 1.5 liters. Stimulated saliva is produced in response to a mechanical, gustatory, olfactory, or pharmacological stimulus, contributing to around 40-50% of daily salivary production. In adults, normal total stimulated salivary flow ranges 1-3 mL/minute, low ranges 0.7-1.0 mL/minute, while hyposalivation is characterized by a stimulated salivary flow <0.7mL/minute.	Baseline and 2 years (24 months)
Primary	Penetration-aspiration Scale to Evaluate Swallowing Function	The videofluoroscopic swallow study (VFSS) is the gold standard diagnostic tool to evaluate oropharyngeal dysphagia. The penetration-aspiration scale (PAS) is an 8-point scale used to grade the severity of penetration or aspiration observed in a videofluoroscopic swallow study. Aspiration is defined as the passing of the bolus below the true vocal folds, and penetration is when the bolus enters the airway but not below the true vocal folds. 1 is normal, no penetration or aspiration. 2-5 is penetration. 6-8 is aspiration.	Baseline and 12 months
Primary	Serial Measurements of Maximal Inter-incisal Distance to Evaluate Trismus (Lockjaw)	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). An average measurement of the three directional areas will be reported.	Baseline and 2 years
Primary	ChemoSensory Questionnaire (CSQ) to Evaluate Smell and Taste Function	The Chemosensory Questionnaire (CSQ) has four questions each on smell and taste. A minimum score of 4 and a maximum of 20 for the smell scale and taste scale are possible with a higher score indicating better function.	2 years
Primary	Number of Participants With Speech Problems Assessed by Head and Neck Health Status Assessment Inventory (HNHSAI)	The Head and Neck Health Status Assessment Inventory (HNHSAI) is a descriptive outcome assessment consisting of 14 yes/no questions to measure number of participants with speech problems.	2 years
Primary	Health Related Quality-of-Life Outcomes Using Validated Quality-of-Life Instrument EORTC QLQ-C30	General quality of life is measured with the European organization for research and treatment of cancer (EORTC) quality of life questionnaire (QLQ) EORTC QLQ-C30 (cancer 30). They are self-administered questionnaires. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for the global health status / QoL represents a high QoL.	2 years
Primary	Health Related Quality-of-life Outcomes Using Validated Quality-of-life Instrument EORTC-QLQ-H&N	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). The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. All of the scales and single-item measures range in score from 0 to 100. For all items and symptom scales, high scores represent a high level of symptomatology/problems.	2 years
Secondary	Rate and Pattern of Locoregional Tumor Recurrence		3 years