Head and Neck CancerNCT00891904
Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
A study testing cetuximab and stereotactic body radiation therapy in people with Head and Neck Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. 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?
- cetuximab and stereotactic body 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
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2011
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the oral cavity, paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx
- Medically or surgically inoperable disease or patient refuses surgery
- Recurrent disease
- Previously irradiated disease meeting the following criteria:
- Prior radiotherapy completed > 6 months from re-irradiation
- Prior radiotherapy in the region of the study cancer that would result in overlap of radiation therapy fields
- Majority of the recurrent tumor volume (> 50%) received prior radiotherapy dose of 30-75 Gy
- No distant metastatic disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 60 days after completion of study treatment
- No prior allergic reaction to study drugs
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior surgical resection of the recurrent primary tumor and/or regional lymphatics
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.
Read the detailed description
OBJECTIVES:
Primary
- To assess the toxicity of stereotactic body radiotherapy delivered concurrently with cetuximab in patients with recurrent squamous cell carcinoma of the head and neck.
Secondary
- To assess the feasibility of delivering this regimen in these patients.
- To assess the impact of this regimen on local control, distant control, and overall survival of these patients.
OUTLINE: Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5. Patients undergo 1 fraction of stereotactic-body radiotherapy (RT) in week 2. At 4 weeks after RT completion, patients may receive additional cetuximab IV combined with a 28-day chemotherapy regimen, per investigator discretion.
After completion of study treatment, patients are followed every 2 months for 1 year, every 3-4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
- Conditions
- Head and Neck Cancer
- Being tested
- cetuximab, stereotactic body radiation therapy
- Keywords
- recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabBiological
Given IV
stereotactic body radiation therapyRadiation
Undergoing Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab | Experimental | Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5 Receives: Biological: cetuximab; Radiation: stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
Measured: Daily while on Treatment
Secondary outcomes (3)
Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients
Measured: 2 years
Local and Distant Control
Measured: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.
Overall Survival
Measured: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 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 posted1 May 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2011
Why it stopped: Low accrual
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 Roswell Park Cancer InstituteThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anurag K. Singh, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891904
- Sponsor's protocol ID
- CDR0000640992
- Other IDs
- RPCI-I-143108
- Status last verified
- Mar 2016
- First submitted
- 30 Apr 2009
- Last updated
- 14 Apr 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 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- ClinicalTrials.gov ID
- NCT00891904
- Acronym / sponsor ID
- CDR0000640992
- Conditions
- Head and Neck Cancer
- Keywords
- recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2011 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Posted 12 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.
Detailed description
OBJECTIVES:
Primary
- To assess the toxicity of stereotactic body radiotherapy delivered concurrently with cetuximab in patients with recurrent squamous cell carcinoma of the head and neck.
Secondary
- To assess the feasibility of delivering this regimen in these patients.
- To assess the impact of this regimen on local control, distant control, and overall survival of these patients.
OUTLINE: Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5. Patients undergo 1 fraction of stereotactic-body radiotherapy (RT) in week 2. At 4 weeks after RT completion, patients may receive additional cetuximab IV combined with a 28-day chemotherapy regimen, per investigator discretion.
After completion of study treatment, patients are followed every 2 months for 1 year, every 3-4 months for 1 year, every 6 months for 2 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 |
|---|---|---|
| Cetuximab | Experimental | Biological: cetuximab, Radiation: stereotactic body radiation therapyPatients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5 |
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 |
|---|---|---|
| cetuximabGiven IV | Biological | Cetuximab |
| stereotactic body radiation therapyUndergoing Radiotherapy | Radiation | Cetuximab |
Primary outcome
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
Time frame: Daily while on Treatment
3 secondary outcomes
Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients
Time frame: 2 years
Local and Distant Control
Time frame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.
Overall Survival
Time frame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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.
Anurag K. Singh, MD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cetuximab and stereotactic body radiation therapy in people with Head and Neck Cancer, run by Roswell Park Cancer Institute 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: stopped early, as of the sponsor's last update on 14 Apr 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 12 Mar 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?
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30 (time frame: Daily while on Treatment). 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 14 Apr 2016.