Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma

NCT00592501 | Completed Phase 2 Results DMC

• 1 other identifier: 05-089
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Nasopharyngeal Carcinoma

Keywords

proton radiation; photon radiation; 5-FU; cisplatin

Outcome Measures

Primary Outcomes (9)

• 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

• Participant Compliance Rate to Assigned Treatment Intervention

  2 years

• 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)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Rate and Pattern of Locoregional Tumor Recurrence

  3 years

Study Arms (1)

Proton/Photon Radiotherapy, Cisplatin, Fluorouracil

EXPERIMENTAL

Radiation: Proton/Photon Radiotherapy; Drug: Cisplatin; Drug: Fluorouracil

Interventions

Proton/Photon Radiotherapy RADIATION

Given once a day, five days a week, for seven weeks.

Proton/Photon Radiotherapy, Cisplatin, Fluorouracil

Cisplatin DRUG

Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.

Proton/Photon Radiotherapy, Cisplatin, Fluorouracil

Fluorouracil DRUG

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

Also known as: 5-FU

Proton/Photon Radiotherapy, Cisplatin, Fluorouracil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or above.
• No active alcohol addiction.
• Women of childbearing potential must have a negative pregnancy test.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Protons; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Annie W. Chan, MD
• Organization: Massachusetts General Hospital

AWCHAN@PARTNERS.ORG

617-726-5184

Study Officials

• Annie W Chan, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Annie W. Chan, MD

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 14, 2008
• Study Start: October 1, 2006
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: October 26, 2021
• Results First Posted: October 26, 2021

Record last verified: 2021-10

Locations

US (2)