Head and Neck CancerPhase 2NCT00057785
Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
A Phase 2 study testing cisplatin, fluorouracil and Intensity modulated radiation therapy in people with Head and Neck Cancer and Oral Complications of Radiation Therapy, run by Radiation Therapy Oncology Group at 17 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oral Complications of Radiation Therapy, Radiation Toxicity
- What is being tested?
- cisplatin, fluorouracil and Intensity modulated radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 17 sitesUnited States
- Study dates
- Feb 2003to Dec 2016
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx
- WHO I-III
- No stage IVC disease
- No evidence of distant metastasis
- Measurable or evaluable disease
- Must have been treated with primary radiotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- White blood cell count (WBC) at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Not specified
Renal
- Creatinine no greater than 1.6 mg/dL
- Creatinine clearance at least 60 mL/min
Other
- Not pregnant (If stage T2b or greater or node-positive disease)
- Negative pregnancy test (If stage T2b or greater or node-positive disease)
- No other prior head and neck cancer
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No active untreated infection
- No other major medical or psychiatric illness that would preclude study entry
- Nutritional and general physical condition compatible with radiotherapy NOTE: *If stage T2b or greater or node-positive disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 6 months since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 6 months since prior radiotherapy for head and neck cancer
Surgery
- No prior head and neck surgery to the primary tumor or lymph nodes except incisional or excisional biopsies
Other
- No other concurrent experimental therapy for cancer
- No amifostine or pilocarpine during or for 3 months after radiotherapy
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Akron City Hospital
Akron, Ohio, 44304
Albuquerque Regional Medical Center at Lovelace Sandia Health System
Albuquerque, New Mexico, 87102
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of California Davis Cancer Center
Davis, California, 95616
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236
Monmouth Medical Center
Long Branch, New Jersey, 07740
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
McKay-Dee Hospital Center
Ogden, Utah, 84403
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, 19111-2497
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, 95815
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.
Read the detailed description
OBJECTIVES:
- Determine the transportability of IMRT to a multi-institutional setting.
- Determine the rate of late xerostomia in patients with nasopharyngeal cancer treated with intensity-modulated radiotherapy (IMRT) with or without chemotherapy.
- Correlate reduction of side effects on salivary flow with compliance in patients treated with these regimens.
- Determine the rate of local-regional control, distant metastasis, and disease-free and overall survival of patients treated with these regimens.
- Determine the acute and late toxicity of these regimens in these patients.
- Determine chemotherapy compliance in patients treated with these regimens.
OUTLINE: Patients undergo daily intensity-modulated radiotherapy (IMRT) 5 days a week for approximately 6.5 weeks (total of 33 fractions) in the absence of disease progression or unacceptable toxicity.
Patients with stage T2b or greater and/or node-positive disease receive cisplatin IV over 20-30 minutes on days 1, 22, and 43 concurrently with IMRT followed by cisplatin IV over 20-30 minutes and fluorouracil IV over 96 hours starting on days 71, 99, and 127.
Quality of life is assessed through saliva measurement at baseline and then at 3, 6, and 12 months after IMRT.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study within 36-40 months.
- Being tested
- cisplatin, fluorouracil, Intensity modulated radiation therapy
- Keywords
- oral complications of radiation therapy, radiation toxicity, stage I squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx
- Medical subject headings
- Head and Neck Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
100 mg/m^2 intravenously on days 1, 22, and 43 and 80 mg/m^2 intravenously on days 71, 99, and 127
fluorouracilDrug
1000 mg/m^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130
Intensity modulated radiation therapyRadiation
The gross tumor and lymph node metastasis, Planning Target Volume (PTV) 70 (Clinical Target Volume [CTV] 70 with a 5 mm margin) will receive 70 Gy in 33 fractions at 2.12 Gy per fraction. Treatment will be delivered once daily, 5 fractions per week, over 6 weeks and 3 days.
| Study group | Role | What they receive |
|---|---|---|
| IMRT +/- chemotherapy | Experimental | Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+ Receives: Drug: cisplatin; Drug: fluorouracil; Radiation: Intensity modulated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered
Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.
Measured: From start of treatment to end of treatment
Secondary outcomes (5)
Rate of Xerostomia at 1 Year (Grade ≥ 2)
Measured: From start of treatment to 1 year
Rate of Locoregional Control at 2 Years
Measured: From registration to 2 years
Whole Mouth Saliva Output Relative to Pretreatment Measurements
Measured: From start of treatment to 1 year
Other Acute and Late Toxicities
Measured: From start of treatment to last follow-up
Chemotherapy Compliance
Measured: From start of treatment to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study startFeb 2003
- Primary completionFeb 2007
- Study completionDec 2016
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nancy Lee, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057785
- Sponsor's protocol ID
- RTOG-0225
- Other IDs
- CDR0000269314
- Status last verified
- Dec 2016
- First submitted
- 7 Apr 2003
- Last updated
- 17 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chen A, Lee N, Yang C, Liu T, Narayan S, Vijayakumar S, Purdy J. Comparison of intensity-modulated radiotherapy using helical tomotherapy and segmental multileaf collimator-based techniques for nasopharyngeal carcinoma: dosimetric analysis incorporating quality assurance guidelines from RTOG 0225. Technol Cancer Res Treat. 2010 Jun;9(3):291-8. doi: 10.1177/153303461000900308.
PubMed 20441239Lee N, Harris J, Garden AS, Straube W, Glisson B, Xia P, Bosch W, Morrison WH, Quivey J, Thorstad W, Jones C, Ang KK. Intensity-modulated radiation therapy with or without chemotherapy for nasopharyngeal carcinoma: radiation therapy oncology group phase II trial 0225. J Clin Oncol. 2009 Aug 1;27(22):3684-90. doi: 10.1200/JCO.2008.19.9109. Epub 2009 Jun 29.
PubMed 19564532Lee NY, Harris J, Garden A, et al.: Phase II multi-institutional study of IMRT ± chemotherapy for nasopharyngeal carcinoma (RTOG 0225): preliminary results. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-23, S13-14, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT00057785
- Acronym / sponsor ID
- RTOG-0225
- Keywords
- oral complications of radiation therapy, radiation toxicity, stage I squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2003
- Primary completion
- Feb 2007 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Apr 2003 (estimated)
- Results
- Posted 13 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.
Detailed description
OBJECTIVES:
- Determine the transportability of IMRT to a multi-institutional setting.
- Determine the rate of late xerostomia in patients with nasopharyngeal cancer treated with intensity-modulated radiotherapy (IMRT) with or without chemotherapy.
- Correlate reduction of side effects on salivary flow with compliance in patients treated with these regimens.
- Determine the rate of local-regional control, distant metastasis, and disease-free and overall survival of patients treated with these regimens.
- Determine the acute and late toxicity of these regimens in these patients.
- Determine chemotherapy compliance in patients treated with these regimens.
OUTLINE: Patients undergo daily intensity-modulated radiotherapy (IMRT) 5 days a week for approximately 6.5 weeks (total of 33 fractions) in the absence of disease progression or unacceptable toxicity.
Patients with stage T2b or greater and/or node-positive disease receive cisplatin IV over 20-30 minutes on days 1, 22, and 43 concurrently with IMRT followed by cisplatin IV over 20-30 minutes and fluorouracil IV over 96 hours starting on days 71, 99, and 127.
Quality of life is assessed through saliva measurement at baseline and then at 3, 6, and 12 months after IMRT.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study within 36-40 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT +/- chemotherapy | Experimental | Drug: cisplatin, Drug: fluorouracil, Radiation: Intensity modulated radiation therapyIntensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cisplatin100 mg/m^2 intravenously on days 1, 22, and 43 and 80 mg/m^2 intravenously on days 71, 99, and 127 | Drug | IMRT +/- chemotherapy |
| fluorouracil1000 mg/m^2/day as 96-hour continuous infusion on days 71-74, 99-102, and 127-130 | Drug | IMRT +/- chemotherapy |
| Intensity modulated radiation therapyThe gross tumor and lymph node metastasis, Planning Target Volume (PTV) 70 (Clinical Target Volume [CTV] 70 with a 5 mm margin) will receive 70 Gy in 33 fractions at 2.12 Gy per fraction. Treatment will be delivered once daily, 5 fractions per week, over 6 weeks and 3 days. | Radiation | IMRT +/- chemotherapy |
Primary outcome
Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered
Time frame: From start of treatment to end of treatment
Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.
5 secondary outcomes
Rate of Xerostomia at 1 Year (Grade ≥ 2)
Time frame: From start of treatment to 1 year
Rate of Locoregional Control at 2 Years
Time frame: From registration to 2 years
Whole Mouth Saliva Output Relative to Pretreatment Measurements
Time frame: From start of treatment to 1 year
Other Acute and Late Toxicities
Time frame: From start of treatment to last follow-up
Chemotherapy Compliance
Time frame: From start of treatment to end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20441239Chen A, Lee N, Yang C, Liu T, Narayan S, Vijayakumar S, Purdy J. Comparison of intensity-modulated radiotherapy using helical tomotherapy and segmental multileaf collimator-based techniques for nasopharyngeal carcinoma: dosimetric analysis incorporating quality assurance guidelines from RTOG 0225. Technol Cancer Res Treat. 2010 Jun;9(3):291-8. doi: 10.1177/153303461000900308.
- Results publication: PubMed 19564532Lee N, Harris J, Garden AS, Straube W, Glisson B, Xia P, Bosch W, Morrison WH, Quivey J, Thorstad W, Jones C, Ang KK. Intensity-modulated radiation therapy with or without chemotherapy for nasopharyngeal carcinoma: radiation therapy oncology group phase II trial 0225. J Clin Oncol. 2009 Aug 1;27(22):3684-90. doi: 10.1200/JCO.2008.19.9109. Epub 2009 Jun 29.
- Results publicationLee NY, Harris J, Garden A, et al.: Phase II multi-institutional study of IMRT ± chemotherapy for nasopharyngeal carcinoma (RTOG 0225): preliminary results. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-23, S13-14, 2007.
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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.
Nancy Lee, MD study chair
Memorial Sloan Kettering Cancer Center
17 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 cisplatin, fluorouracil and Intensity modulated radiation therapy in people with Head and Neck Cancer and Oral Complications of Radiation Therapy, run by Radiation Therapy Oncology Group at 17 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?
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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 13 Oct 2014). 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?
Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered (time frame: From start of treatment to end of treatment). 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 NCT00057785, which also lists 3 linked publications.
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 17 Feb 2017.