Nasopharyngeal CarcinomaPhase 2NCT00592501

Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma

A Phase 2 study testing Proton/Photon Radiotherapy, Cisplatin and Fluorouracil in people with Nasopharyngeal Carcinoma, run by Massachusetts General Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Nasopharyngeal Carcinoma
What is being tested?: Proton/Photon Radiotherapy, Cisplatin and Fluorouracil
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 2 sitesUnited States
Study dates: Oct 2006to Apr 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Nasopharyngeal Carcinoma
Being tested: Proton/Photon Radiotherapy, Cisplatin, Fluorouracil
Keywords: proton radiation, photon radiation, 5-FU, cisplatin
Medical subject headings: Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Proton/Photon RadiotherapyRadiation
Given once a day, five days a week, for seven weeks.
CisplatinDrug
Given intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.
FluorouracilDrug
Also called 5-FU
Given as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy.

Study groups in NCT00592501
Study group	Role	What they receive
Proton/Photon Radiotherapy, Cisplatin, Fluorouracil	Experimental	Not described Receives: Radiation: Proton/Photon Radiotherapy; Drug: Cisplatin; Drug: Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Acute Toxicity
Acute toxicities are side affects that occur during treatment and 90 days after completion.
Measured: 54 days of chemoradiation treatment and 90 days after completion, up to 144 days total
Participant Compliance Rate to Assigned Treatment Intervention
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years

Secondary outcomes (1)

Rate and Pattern of Locoregional Tumor Recurrence
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Apr 2019

First posted14 Jan 2008 (estimated)
Study startOct 2006
Primary completionApr 2019
Study completionApr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00592501
Sponsor's protocol ID: 05-089
Status last verified: Oct 2021
First submitted: 28 Dec 2007
Last updated: 26 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nasopharyngeal Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Proton Radiotherapy With Chemotherapy for Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT00592501
Acronym / sponsor ID: 05-089
Conditions: Nasopharyngeal Carcinoma
Keywords: proton radiation, photon radiation, 5-FU, cisplatin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Brigham and Women's Hospital, Dana-Farber Cancer Institute
Study start: Oct 2006
Primary completion: Apr 2019 (actual)
Study completion: Apr 2019 (actual)
First posted: 14 Jan 2008 (estimated)
Results: Posted 26 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Proton/Photon Radiotherapy, Cisplatin, Fluorouracil	Experimental	Radiation: Proton/Photon Radiotherapy, Drug: Cisplatin, Drug: Fluorouracil

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Proton/Photon RadiotherapyGiven once a day, five days a week, for seven weeks.	Radiation	Proton/Photon Radiotherapy, Cisplatin, Fluorouracil
CisplatinGiven intravenously once every three weeks during radiation treatment, then once every four weeks for three cycles.	Drug	Proton/Photon Radiotherapy, Cisplatin, Fluorouracil
FluorouracilAlso: 5-FUGiven as continuous infusion over 4 days starting on the day cisplatin is received after radiation therapy.	Drug	Proton/Photon Radiotherapy, Cisplatin, Fluorouracil

Primary outcome

Number of Participants With Acute Toxicity
Time frame: 54 days of chemoradiation treatment and 90 days after completion, up to 144 days total
Acute toxicities are side affects that occur during treatment and 90 days after completion.
Participant Compliance Rate to Assigned Treatment Intervention
Time frame: 2 years
Sialometry to Evaluate Xerostomia (Dry Mouth)
Time frame: Baseline and 2 years (24 months)
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.
Penetration-aspiration Scale to Evaluate Swallowing Function
Time frame: Baseline and 12 months
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.
Serial Measurements of Maximal Inter-incisal Distance to Evaluate Trismus (Lockjaw)
Time frame: Baseline and 2 years
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.
ChemoSensory Questionnaire (CSQ) to Evaluate Smell and Taste Function
Time frame: 2 years
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.
Number of Participants With Speech Problems Assessed by Head and Neck Health Status Assessment Inventory (HNHSAI)
Time frame: 2 years
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.
Health Related Quality-of-Life Outcomes Using Validated Quality-of-Life Instrument EORTC QLQ-C30
Time frame: 2 years
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.
Health Related Quality-of-life Outcomes Using Validated Quality-of-life Instrument EORTC-QLQ-H&N
Time frame: 2 years
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.

1 secondary outcome

Rate and Pattern of Locoregional Tumor Recurrence
Time frame: 3 years

Results and safety

Results posted to the registry on 26 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Proton/Photon Radiotherapy, Cisplatin, Fluorouracil	25	23

Primary outcome: Number of Participants With Acute Toxicity

Time frame: 54 days of chemoradiation treatment and 90 days after completion, up to 144 days total. Count of participants. Unit: Participants

Measure	Proton/Photon Radiotherapy, Cisplatin, Fluorouracil n = 23
Value	23

Primary outcome: Participant Compliance Rate to Assigned Treatment Intervention

Time frame: 2 years. Number. Unit: percentage of participants

Measure	Proton/Photon Radiotherapy, Cisplatin, Fluorouracil n = 23
Received at least 2 cycles of concurrent chemotherapy	100
Received at least 2 cycles of adjuvant chemotherapy	75
Received 3 cycles of concurrent chemotherapy	83

Primary outcome: Sialometry to Evaluate Xerostomia (Dry Mouth)

Time frame: Baseline and 2 years (24 months). Mean (Standard Deviation). Unit: milliliters

Measure	Proton/Photon Radiotherapy, Cisplatin, Fluorouracil n = 23
Unstimatulated saliva at baseline	1.89 (1.16)
Unstimulated saliva at 24 months	0.95 (0.57)

Population analysed: The mean values below are for all analyzed participants.

Primary outcome: Penetration-aspiration Scale to Evaluate Swallowing Function

Time frame: Baseline and 12 months. Mean (Full Range). Unit: score on a scale

Measure	Proton/Photon Radiotherapy, Cisplatin, Fluorouracil n = 23
Penetration-aspiration scale at baseline	1.04 (1.00 to 2.00)
Penetration-aspiration scale at 12 months after radiation therapy	1.36 (1.00 to 5.00)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Toxicity evaluation occurred during protocol therapy and 5+ years of follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Proton/Photon Radiotherapy, Cisplatin, Fluorouracil	1 of 23 (4.3%)	23 of 23 (100%)	6 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Annie W Chan, MD principal investigator

Massachusetts General Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Proton/Photon Radiotherapy, Cisplatin and Fluorouracil in people with Nasopharyngeal Carcinoma, run by Massachusetts General Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Acute Toxicity (time frame: 54 days of chemoradiation treatment and 90 days after completion, up to 144 days total). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00592501.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.