Head and Neck CancerNCT00580983
Optimized Intensity Modulated Irradiation for Head and Neck Cancer
A study testing IMRT, Paclitaxel and Carboplatin in people with Head and Neck Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test whether the use of advanced radiation therapy delivery techniques can spare a patient's normal tissue, including salivary glands, from radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- IMRT, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jun 2010
- Phase
- Interventional
- 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
- All patients must have histologically confirmed invasive cancer of the head and neck.
- Irradiation to both neck sides is required.
- Standard radiation techniques would irradiate most of both parotid glands to a high dose (>50 Gy). Patients with oropharyngeal, oral, nasopharyngeal, hypopharyngeal and advanced laryngeal cancer are expected to fulfill this requirement.
- Patients with resectable disease that is either measurable, evaluable or non-measurable disease (post-operative) will be eligible.
- Karnofsky performance status >60
- Patients receiving or not receiving chemotherapy are eligible.
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- All patients must sign an informed consent.
- Pre-treatment laboratory criteria:
- WBC (White Blood Cell) > 3500/ul, granulocyte > 1500/ul.
- Platelet count > 100,000/ul.
- Creatinine clearance > 60 cc/min. to receive cisplatin; creatinine clearance 30-59 cc/min to receive carboplatin.
- Bilirubin < 1.5 mg% with no evidence of obstructive liver disease.
- AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) equal to or less than 2.5 x upper limit of normal.
Who cannot join
- Patients who received past irradiation to the head and neck are not eligible.
- Prior head and neck malignancy or history of other prior non-head and neck malignancy within the past 3 years.
- Prior head and neck radiation or prior chemotherapy.
- Documented evidence of distant metastases.
- Active infection.
- Pregnancy or lactation; patients must use effective contraception during the course of the clinical trial.
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- Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patients ability to tolerate this treatment.
- Patients residing in prison.
- Age < 18 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109-5010
About this study
The purpose of this study is to test whether the use of advanced radiation therapy delivery techniques can spare a patient's normal tissue, including salivary glands, from radiation. This study is being done to try to reduce radiation side effects, especially mouth dryness, which happens with standard radiation methods. In order to reduce these side effects, other normal tissues may receive a different radiation dose (sometimes more) than what would have been received using standard radiation therapy. A secondary goal of this study is to determine if the type of tumor a patient has can be controlled at least as well (or better) using this advanced radiation therapy delivery technique as it would be if the patient was treated with standard radiation therapy.
Read the detailed description
Studies show that a dose response relationship in the salivary glands exists and that it may be possible to improve significantly post-radiation xerostomia and quality of life if radiation techniques can be devised that would spare the salivary glands while adequately treating the targets. A new treatment modality (computer-optimized IMRT) facilitates increased sparing of noninvolved tissue, specifically the sparing of both parotid glands, and more conformal high-dose delivery to the bilateral neck targets in patients with head and neck cancer. This study will evaluate the benefits regarding xerostomia-specific and general QOL in patients receiving head and neck RT using this modality. Assessment of swallowing dysfunction and aspiration will be made using videofluoroscopy. In addition, this study will evaluate the pattern of local/regional tumor recurrence, to assess whether sparing both parotid glands may cause tumor recurrence in spared neck areas.
- Conditions
- Head and Neck Cancer
- Being tested
- IMRT, Paclitaxel, Carboplatin, Cisplatin, 5-Fluorouracil
- Keywords
- Head and Neck cancer
- 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.
IMRTRadiation
PaclitaxelDrug
CarboplatinDrug
CisplatinDrug
5-FluorouracilDrug
| Study group | Role | What they receive |
|---|---|---|
| Chemo-IMRT | Experimental | Chemotherapy:
Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.
Intensity-modulated Radiation Therapy (IMRT):
Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.
Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions. Receives: Radiation: IMRT; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Grade 0-1 Observer-rated Dysphagia
To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy, the percentage of participants with observer-rated dysphagia was calculated.
Measured: 12 months
Secondary outcomes (1)
The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures
To assess the relationships between the mean radiotherapy dose delivered and objectively measured dysphagia.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startAug 2003
- Primary completionJun 2010
- Study completionJun 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.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avraham Eisbruch, M.D., Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580983
- Sponsor's protocol ID
- UMCC 2-21
- Other IDs
- HUM 43020 Legacy 2002-513
- Status last verified
- Jul 2016
- First submitted
- 25 Dec 2007
- Last updated
- 7 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Intensity Modulated Irradiation for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00580983
- Acronym / sponsor ID
- UMCC 2-21
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 14 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether the use of advanced radiation therapy delivery techniques can spare a patient's normal tissue, including salivary glands, from radiation. This study is being done to try to reduce radiation side effects, especially mouth dryness, which happens with standard radiation methods. In order to reduce these side effects, other normal tissues may receive a different radiation dose (sometimes more) than what would have been received using standard radiation therapy. A secondary goal of this study is to determine if the type of tumor a patient has can be controlled at least as well (or better) using this advanced radiation therapy delivery technique as it would be if the patient was treated with standard radiation therapy.
Detailed description
Studies show that a dose response relationship in the salivary glands exists and that it may be possible to improve significantly post-radiation xerostomia and quality of life if radiation techniques can be devised that would spare the salivary glands while adequately treating the targets. A new treatment modality (computer-optimized IMRT) facilitates increased sparing of noninvolved tissue, specifically the sparing of both parotid glands, and more conformal high-dose delivery to the bilateral neck targets in patients with head and neck cancer. This study will evaluate the benefits regarding xerostomia-specific and general QOL in patients receiving head and neck RT using this modality. Assessment of swallowing dysfunction and aspiration will be made using videofluoroscopy. In addition, this study will evaluate the pattern of local/regional tumor recurrence, to assess whether sparing both parotid glands may cause tumor recurrence in spared neck areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemo-IMRT | Experimental | Radiation: IMRT, Drug: Paclitaxel, Drug: Carboplatin, Drug: Cisplatin, Drug: 5-FluorouracilChemotherapy: Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days. Intensity-modulated Radiation Therapy (IMRT): Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions. Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- All patients must have histologically confirmed invasive cancer of the head and neck.
- Irradiation to both neck sides is required.
- Standard radiation techniques would irradiate most of both parotid glands to a high dose (>50 Gy). Patients with oropharyngeal, oral, nasopharyngeal, hypopharyngeal and advanced laryngeal cancer are expected to fulfill this requirement.
- Patients with resectable disease that is either measurable, evaluable or non-measurable disease (post-operative) will be eligible.
- Karnofsky performance status >60
Key exclusion criteria (9 listed)
- Patients who received past irradiation to the head and neck are not eligible.
- Prior head and neck malignancy or history of other prior non-head and neck malignancy within the past 3 years.
- Prior head and neck radiation or prior chemotherapy.
- Documented evidence of distant metastases.
- Active 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 |
|---|---|---|
| IMRT | Radiation | Chemo-IMRT |
| Paclitaxel | Drug | Chemo-IMRT |
| Carboplatin | Drug | Chemo-IMRT |
| Cisplatin | Drug | Chemo-IMRT |
| 5-Fluorouracil | Drug | Chemo-IMRT |
Primary outcome
Percentage of Participants With Grade 0-1 Observer-rated Dysphagia
Time frame: 12 months
To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy, the percentage of participants with observer-rated dysphagia was calculated.
1 secondary outcome
The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- 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.
Avraham Eisbruch, M.D. principal investigator
University of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMRT, Paclitaxel and Carboplatin in people with Head and Neck Cancer, run by University of Michigan Rogel 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?
The sponsor lists 13 inclusion and 9 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 7 Sep 2016. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 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?
Percentage of Participants With Grade 0-1 Observer-rated Dysphagia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2016.