Head and Neck CancerPhase 1/2NCT00052429
High-Dose Radiation Therapy Plus Chemotherapy in Treating Patients With Advanced Nose or Throat Cancer
A Phase 1/2 study testing cisplatin, fluorouracil and adjuvant therapy in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- cisplatin, fluorouracil and adjuvant therapy
- 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
- 1 siteUnited States
- Study dates
- Sep 2002to Nov 2010
- Phase
- Phase 1/2
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed nasopharyngeal cancer
- Stage II-IVB
- Newly diagnosed
- No distant metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- AST no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- Calcium no greater than 11.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Medically able to tolerate a definitive course of radiotherapy and the necessary immobilization
- No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for this diagnosis
- More than 3 years since other prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for this diagnosis
- More than 3 years since other prior radiotherapy
- No prior radiotherapy to the head and neck region
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients With Stage II-IVB Nasopharyngeal Carcinoma
RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining high-dose radiation with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage IV nasopharyngeal cancer.
Read the detailed description
OUTLINE: Cohorts of 10 patients receive the following treatment to assess for dose-limiting toxicity.
Phase I
- Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
- Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
- Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II.
Phase II
- Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
- Conditions
- Head and Neck Cancer
- Being tested
- cisplatin, fluorouracil, adjuvant therapy, radiation therapy
- Keywords
- stage II lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
fluorouracilDrug
adjuvant therapyProcedure or surgery
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Radiation Therapy Plus Chemotherapy | Experimental | Phase I
* Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
* Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
* Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II
* Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. Receives: Drug: cisplatin; Drug: fluorouracil; Procedure: adjuvant therapy; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate of Patients
Patients will be followed indefinitely and will have standard screening for development of distant metastases, including physical exam, as well as liver function tests and a chest radiograph annually. Patients will be classified as progression free as long as they remain alive with local, regional or distant recurrence.
Measured: up to 77 months
Local Control of Participants
Patients will be classified as controlled as long as there is no clinical or radiographic evidence of disease progression. Physical exam with fiberoptic nasopharyngoscopy will be performed approximately every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.
Measured: every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2002
- Primary completionNov 2010
- Study completionNov 2010
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 (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Suzanne Wolden, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052429
- Sponsor's protocol ID
- 02-077
- Other IDs
- MSKCC-02077, NCI-H02-0101
- Status last verified
- Dec 2017
- First submitted
- 24 Jan 2003
- Last updated
- 9 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Bakst RL, Lee N, Pfister DG, Zelefsky MJ, Hunt MA, Kraus DH, Wolden SL. Hypofractionated dose-painting intensity modulated radiation therapy with chemotherapy for nasopharyngeal carcinoma: a prospective trial. Int J Radiat Oncol Biol Phys. 2011 May 1;80(1):148-53. doi: 10.1016/j.ijrobp.2010.01.026. Epub 2010 Jun 3.
PubMed 20605352
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients With Stage II-IVB Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT00052429
- Acronym / sponsor ID
- 02-077
- Conditions
- Head and Neck Cancer
- Keywords
- stage II lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2002
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 22 Feb 2016
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 that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining high-dose radiation with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage IV nasopharyngeal cancer.
Detailed description
OUTLINE: Cohorts of 10 patients receive the following treatment to assess for dose-limiting toxicity.
Phase I
- Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.
- Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.
- Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II.
Phase II
- Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Dose Radiation Therapy Plus Chemotherapy | Experimental | Drug: cisplatin, Drug: fluorouracil, Procedure: adjuvant therapy, Radiation: radiation therapyPhase I * Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1. * Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26. * Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II * Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| cisplatin | Drug | High-Dose Radiation Therapy Plus Chemotherapy |
| fluorouracil | Drug | High-Dose Radiation Therapy Plus Chemotherapy |
| adjuvant therapy | Procedure or surgery | High-Dose Radiation Therapy Plus Chemotherapy |
| radiation therapy | Radiation | High-Dose Radiation Therapy Plus Chemotherapy |
Primary outcome
Survival Rate of Patients
Time frame: up to 77 months
Patients will be followed indefinitely and will have standard screening for development of distant metastases, including physical exam, as well as liver function tests and a chest radiograph annually. Patients will be classified as progression free as long as they remain alive with local, regional or distant recurrence.
Local Control of Participants
Time frame: every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.
Patients will be classified as controlled as long as there is no clinical or radiographic evidence of disease progression. Physical exam with fiberoptic nasopharyngoscopy will be performed approximately every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20605352Bakst RL, Lee N, Pfister DG, Zelefsky MJ, Hunt MA, Kraus DH, Wolden SL. Hypofractionated dose-painting intensity modulated radiation therapy with chemotherapy for nasopharyngeal carcinoma: a prospective trial. Int J Radiat Oncol Biol Phys. 2011 May 1;80(1):148-53. doi: 10.1016/j.ijrobp.2010.01.026. Epub 2010 Jun 3.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Suzanne Wolden, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cisplatin, fluorouracil and adjuvant therapy in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 22 Feb 2016). 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?
Survival Rate of Patients (time frame: up to 77 months). The study lists 2 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 NCT00052429, which also lists 1 linked publication.
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 9 Jan 2018.