Head and Neck CancerEarly Phase 1NCT00140556
Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer
A Early Phase 1 study testing Chemoradiotherapy, Cisplatin and Bevacizumab in people with Head and Neck Cancer and Pharynx Cancer, run by David M. Brizel, MD at 1 site in United States.
Trial summary
Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia and high levels of angiogenesis (blood vessel formation) are associated with treatment failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Pharynx Cancer
- What is being tested?
- Chemoradiotherapy, Cisplatin and Bevacizumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Apr 2010
- Phase
- Early Phase 1
- 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
- Locally advanced squamous carcinoma of the head and neck (AJCC stages II/IV, M0, and excluding T1N1 and T1N2) undergoing curative intent concurrent chemoradiation.
- Previous treatment of any sort other than a biopsy is not allowed.
- Eligible anatomic sites:
- oral cavity
- oropharynx
- hypopharynx
Show all 9Show fewer
- supraglottic
- glottic larynx
- KPS > 60
Who cannot join
- Nasopharynx primary
- History of malignancy other than basal cell skin cancer.
- History of claudication, bleeding, or thromboembolic disorders. Patients receiving heparin or Coumadin therapy are ineligible.
- Primary tumor or lymph node encasement of the carotid artery
- Blood pressure of >150/100 mmHg
- Unstable angina
Show all 22Show fewer
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to Day 0
- Pregnant (positive pregnancy test) or lactating
- Urine protein : creatinine ratio ≥ 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- AST, ALT, or bilirubin > 1.5 x normal
- PT or PTT > 1.5 x normal
- Platelets < 100,000
- WBC < 2000
- Hgb < 10
- Creatinine clearance < 60 mL/hr
- Refusal to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Radiation Oncology; Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Concurrent Angiogenic and EGFR Blockade in Conjunction With Curative Intent Chemoradiation for Locally Advanced Head and Neck Cancer
Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia and high levels of angiogenesis (blood vessel formation) are associated with treatment failure. Preclinical models reveal that radiotherapy itself may induce tumor secretion of vascular endothelial growth factor (VEGF). Curability may consequently be reduced by multiple mechanisms. Over-expression of epidermal growth factor receptor (EGFR) also occurs commonly and increases the risk of treatment failure. The addition of EGFR blockade to RT alone increases the chance of a cure. Concurrent VEGF and EGFR blockade could be synergistic with one another and improve the effectiveness of concurrent chemoradiation for advanced head and neck cancer.
This study will add angiogenic and epidermal growth factor receptor (EGFR) blockade into an established program of curative intent concurrent chemoradiation for locally advanced head and neck cancer. The safety and effectiveness of delivering the drugs bevacizumab and Tarceva in conjunction with twice daily irradiation and concurrent cisplatin (CDDP) chemotherapy will be determined.
Read the detailed description
Pre Radiation Period:
- Bevacizumab (10 mg/kg) on days -14 and 0, or
- Tarceva (100 mg) daily from -14-0, or
- Bevacizumab (10 mg/kg) on days -14 and 0; Tarceva (100 mg) daily from -14-0
Chemoradiation Period:
- Radiotherapy may be delivered via conventional 2-D, conformal 3-D, or intensity modulated (IMRT) technique as is clinically indicated. Radiotherapy and CDDP doses will be delivered uniformly to all treatment cohorts:
- RT: 1.25 Gy BID M-F with a 6 hour interfraction interval
- Treatment break during week 4. Total dose 70 Gy/7 weeks
- CDDP: 33 mg/m2 M-W on weeks 1 and 5 of RT with standard DUMC hydration and anti-emetic regimens
- Bevacizumab (10mg/kg): Monday of weeks 1, 3, 5, 7 of RT
- Tarceva (100 mg): Daily for weeks 1-7 of treatment, except for days receiving CDDP
Safety Assessments:
- Baseline and then weekly assessments of blood pressure and urine protein : creatinine ratios during lead in and chemoRT phases of treatment
- Baseline carotid Doppler ultrasound evaluation
- Carotid Doppler ultrasound evaluation 1 month post-chemoRT
Efficacy Assessments:
- MR Imaging/Spectroscopy to be done at baseline, end of lead-in phase, end of week 1 of chemoRT, and end of chemoRT
- Angiogenic and EGFR related cytokines. Specifically, blood samples will be obtained to assay levels of VEGF, b-FGF, IL-8, D-dimer, EGF, TGF. These samples will be obtained on the same dates as the MR studies with an additional set of samples obtained at the midpoint of the lead in phase of treatment (day -7).
Clinical Assessments:
- All patients will undergo a minimum of once weekly interval history and physical examination including fiberoptic pharyngoscopy/laryngoscopy when indicated in the Department of Radiation Oncology to monitor for side effects and response to treatment as per standard routine for the care of patients with head and neck cancer.
- Patient compliance with Tarceva administration monitored via diary MRI/MRS (Magnetic Resonance Spectroscopy) DE-MRI
- Conditions
- Head and Neck Cancer, Pharynx Cancer
- Being tested
- Chemoradiotherapy, Cisplatin, Bevacizumab, Erlotinib
- Keywords
- head and neck cancer, targeted therapy, bevacizumab, erlotinib, Tarceva, radiotherapy, concurrent chemotherapy, pharynx cancer, tonsil cancer, hyperfractionation, angiogenesis, epidermal growth factor, vascular endothelial growth factor, magnetic resonance spectroscopy, cancer of the head and neck, upper aerodigestive tract neoplasms, pharynx neoplasms
- Medical subject headings
- Head and Neck Neoplasms, Pharyngeal Neoplasms, Tonsillar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoradiotherapyRadiation
External beam radiation daily (M-F)
CisplatinDrug
Cisplatin week 1 and 5 of radiation
BevacizumabDrug
Also called Avastin
Bevacizumab (Avastin) day 1 of weeks 1, 3, and 5 of radiation
ErlotinibDrug
Also called Tarceva
Erlotinib daily during radiation
| Study group | Role | What they receive |
|---|---|---|
| ChemoRadiotherapy | Experimental | Radiation Therapy concurrent with cisplatin chemotherapy, Avastin and Tarceva Receives: Radiation: Chemoradiotherapy; Drug: Cisplatin; Drug: Bevacizumab; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Resolution
Complete response (resolution) of tumor on clinical exam.
Measured: Within 30 days of completing RT
Secondary outcomes (2)
Local Regional Control
Measured: 1 yr following chemoradiation
Failure Free Survival
Measured: 3 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionMay 2009
- Study completionApr 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 (8)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
- Early Phase 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- David M. Brizel, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals
- Responsible party
- Sponsor-investigator, David M. Brizel, MD, Duke University
- Investigators
- David M Brizel, MD, Principal investigator, Department of Radiation Oncology; Duke University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140556
- Sponsor's protocol ID
- Pro00008840
- Other IDs
- 7077
- Status last verified
- Jan 2013
- First submitted
- 29 Aug 2005
- Last updated
- 18 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Brizel DM, Dodge RK, Clough RW, Dewhirst MW. Oxygenation of head and neck cancer: changes during radiotherapy and impact on treatment outcome. Radiother Oncol. 1999 Nov;53(2):113-7. doi: 10.1016/s0167-8140(99)00102-4.
PubMed 10665787Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. doi: 10.1056/NEJM199806183382503.
PubMed 9632446Brizel DM, Schroeder T, Scher RL, Walenta S, Clough RW, Dewhirst MW, Mueller-Klieser W. Elevated tumor lactate concentrations predict for an increased risk of metastases in head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Oct 1;51(2):349-53. doi: 10.1016/s0360-3016(01)01630-3.
PubMed 11567808Dewhirst MW, Poulson JM, Yu D, Sanders L, Lora-Michiels M, Vujaskovic Z, Jones EL, Samulski TV, Powers BE, Brizel DM, Prosnitz LR, Charles HC. Relation between pO2, 31P magnetic resonance spectroscopy parameters and treatment outcome in patients with high-grade soft tissue sarcomas treated with thermoradiotherapy. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):480-91. doi: 10.1016/j.ijrobp.2004.06.211.
PubMed 15667971Moeller BJ, Cao Y, Li CY, Dewhirst MW. Radiation activates HIF-1 to regulate vascular radiosensitivity in tumors: role of reoxygenation, free radicals, and stress granules. Cancer Cell. 2004 May;5(5):429-41. doi: 10.1016/s1535-6108(04)00115-1.
PubMed 15144951Craciunescu O, Brizel D, Cleland E, Yoo D, Muradyan N, Carroll M, Barboriak D, MacFall J. Dynamic contrast enhanced-MRI in head and neck cancer patients: variability of the precontrast longitudinal relaxation time (T10). Med Phys. 2010 Jun;37(6):2683-92. doi: 10.1118/1.3427487.
PubMed 20632579Yoo DS, Kirkpatrick JP, Craciunescu O, Broadwater G, Peterson BL, Carroll MD, Clough R, MacFall JR, Hoang J, Scher RL, Esclamado RM, Dunphy FR, Ready NE, Brizel DM. Prospective trial of synchronous bevacizumab, erlotinib, and concurrent chemoradiation in locally advanced head and neck cancer. Clin Cancer Res. 2012 Mar 1;18(5):1404-14. doi: 10.1158/1078-0432.CCR-11-1982. Epub 2012 Jan 17.
PubMed 22253412Craciunescu OI, Yoo DS, Cleland E, Muradyan N, Carroll MD, MacFall JR, Barboriak DP, Brizel DM. Dynamic contrast-enhanced MRI in head-and-neck cancer: the impact of region of interest selection on the intra- and interpatient variability of pharmacokinetic parameters. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):e345-50. doi: 10.1016/j.ijrobp.2011.05.059. Epub 2011 Oct 8.
PubMed 21985945
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Angiogenic and EGFR Blockade in Conjunction With Curative Intent Chemoradiation for Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00140556
- Acronym / sponsor ID
- Pro00008840
- Conditions
- Head and Neck Cancer, Pharynx Cancer
- Keywords
- head and neck cancer, targeted therapy, bevacizumab, erlotinib, Tarceva, radiotherapy, concurrent chemotherapy, pharynx cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- David M. Brizel, MDUniversity, hospital or other
- Collaborators
- Genentech, Inc., OSI Pharmaceuticals
- Study start
- Aug 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Posted 31 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia and high levels of angiogenesis (blood vessel formation) are associated with treatment failure. Preclinical models reveal that radiotherapy itself may induce tumor secretion of vascular endothelial growth factor (VEGF). Curability may consequently be reduced by multiple mechanisms. Over-expression of epidermal growth factor receptor (EGFR) also occurs commonly and increases the risk of treatment failure. The addition of EGFR blockade to RT alone increases the chance of a cure. Concurrent VEGF and EGFR blockade could be synergistic with one another and improve the effectiveness of concurrent chemoradiation for advanced head and neck cancer.
This study will add angiogenic and epidermal growth factor receptor (EGFR) blockade into an established program of curative intent concurrent chemoradiation for locally advanced head and neck cancer. The safety and effectiveness of delivering the drugs bevacizumab and Tarceva in conjunction with twice daily irradiation and concurrent cisplatin (CDDP) chemotherapy will be determined.
Detailed description
Pre Radiation Period:
- Bevacizumab (10 mg/kg) on days -14 and 0, or
- Tarceva (100 mg) daily from -14-0, or
- Bevacizumab (10 mg/kg) on days -14 and 0; Tarceva (100 mg) daily from -14-0
Chemoradiation Period:
- Radiotherapy may be delivered via conventional 2-D, conformal 3-D, or intensity modulated (IMRT) technique as is clinically indicated. Radiotherapy and CDDP doses will be delivered uniformly to all treatment cohorts:
- RT: 1.25 Gy BID M-F with a 6 hour interfraction interval
- Treatment break during week 4. Total dose 70 Gy/7 weeks
- CDDP: 33 mg/m2 M-W on weeks 1 and 5 of RT with standard DUMC hydration and anti-emetic regimens
- Bevacizumab (10mg/kg): Monday of weeks 1, 3, 5, 7 of RT
- Tarceva (100 mg): Daily for weeks 1-7 of treatment, except for days receiving CDDP
Safety Assessments:
- Baseline and then weekly assessments of blood pressure and urine protein : creatinine ratios during lead in and chemoRT phases of treatment
- Baseline carotid Doppler ultrasound evaluation
- Carotid Doppler ultrasound evaluation 1 month post-chemoRT
Efficacy Assessments:
- MR Imaging/Spectroscopy to be done at baseline, end of lead-in phase, end of week 1 of chemoRT, and end of chemoRT
- Angiogenic and EGFR related cytokines. Specifically, blood samples will be obtained to assay levels of VEGF, b-FGF, IL-8, D-dimer, EGF, TGF. These samples will be obtained on the same dates as the MR studies with an additional set of samples obtained at the midpoint of the lead in phase of treatment (day -7).
Clinical Assessments:
- All patients will undergo a minimum of once weekly interval history and physical examination including fiberoptic pharyngoscopy/laryngoscopy when indicated in the Department of Radiation Oncology to monitor for side effects and response to treatment as per standard routine for the care of patients with head and neck cancer.
- Patient compliance with Tarceva administration monitored via diary MRI/MRS (Magnetic Resonance Spectroscopy) DE-MRI
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ChemoRadiotherapy | Experimental | Radiation: Chemoradiotherapy, Drug: Cisplatin, Drug: Bevacizumab, Drug: ErlotinibRadiation Therapy concurrent with cisplatin chemotherapy, Avastin and Tarceva |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Locally advanced squamous carcinoma of the head and neck (AJCC stages II/IV, M0, and excluding T1N1 and T1N2) undergoing curative intent concurrent chemoradiation.
- Previous treatment of any sort other than a biopsy is not allowed.
- Eligible anatomic sites:
- KPS > 60
Key exclusion criteria (22 listed)
- Nasopharynx primary
- History of malignancy other than basal cell skin cancer.
- History of claudication, bleeding, or thromboembolic disorders. Patients receiving heparin or Coumadin therapy are ineligible.
- Primary tumor or lymph node encasement of the carotid artery
- Blood pressure of >150/100 mmHg
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 |
|---|---|---|
| ChemoradiotherapyExternal beam radiation daily (M-F) | Radiation | ChemoRadiotherapy |
| CisplatinCisplatin week 1 and 5 of radiation | Drug | ChemoRadiotherapy |
| BevacizumabAlso: AvastinBevacizumab (Avastin) day 1 of weeks 1, 3, and 5 of radiation | Drug | ChemoRadiotherapy |
| ErlotinibAlso: TarcevaErlotinib daily during radiation | Drug | ChemoRadiotherapy |
Primary outcome
Tumor Resolution
Time frame: Within 30 days of completing RT
Complete response (resolution) of tumor on clinical exam.
2 secondary outcomes
Local Regional Control
Time frame: 1 yr following chemoradiation
Failure Free Survival
Time frame: 3 yrs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10665787Brizel DM, Dodge RK, Clough RW, Dewhirst MW. Oxygenation of head and neck cancer: changes during radiotherapy and impact on treatment outcome. Radiother Oncol. 1999 Nov;53(2):113-7. doi: 10.1016/s0167-8140(99)00102-4.
- Background: PubMed 9632446Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. doi: 10.1056/NEJM199806183382503.
- Background: PubMed 11567808Brizel DM, Schroeder T, Scher RL, Walenta S, Clough RW, Dewhirst MW, Mueller-Klieser W. Elevated tumor lactate concentrations predict for an increased risk of metastases in head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Oct 1;51(2):349-53. doi: 10.1016/s0360-3016(01)01630-3.
- Background: PubMed 15667971Dewhirst MW, Poulson JM, Yu D, Sanders L, Lora-Michiels M, Vujaskovic Z, Jones EL, Samulski TV, Powers BE, Brizel DM, Prosnitz LR, Charles HC. Relation between pO2, 31P magnetic resonance spectroscopy parameters and treatment outcome in patients with high-grade soft tissue sarcomas treated with thermoradiotherapy. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):480-91. doi: 10.1016/j.ijrobp.2004.06.211.
- Background: PubMed 15144951Moeller BJ, Cao Y, Li CY, Dewhirst MW. Radiation activates HIF-1 to regulate vascular radiosensitivity in tumors: role of reoxygenation, free radicals, and stress granules. Cancer Cell. 2004 May;5(5):429-41. doi: 10.1016/s1535-6108(04)00115-1.
- Results publication: PubMed 20632579Craciunescu O, Brizel D, Cleland E, Yoo D, Muradyan N, Carroll M, Barboriak D, MacFall J. Dynamic contrast enhanced-MRI in head and neck cancer patients: variability of the precontrast longitudinal relaxation time (T10). Med Phys. 2010 Jun;37(6):2683-92. doi: 10.1118/1.3427487.
- Derived from this study: PubMed 22253412Yoo DS, Kirkpatrick JP, Craciunescu O, Broadwater G, Peterson BL, Carroll MD, Clough R, MacFall JR, Hoang J, Scher RL, Esclamado RM, Dunphy FR, Ready NE, Brizel DM. Prospective trial of synchronous bevacizumab, erlotinib, and concurrent chemoradiation in locally advanced head and neck cancer. Clin Cancer Res. 2012 Mar 1;18(5):1404-14. doi: 10.1158/1078-0432.CCR-11-1982. Epub 2012 Jan 17.
- Derived from this study: PubMed 21985945Craciunescu OI, Yoo DS, Cleland E, Muradyan N, Carroll MD, MacFall JR, Barboriak DP, Brizel DM. Dynamic contrast-enhanced MRI in head-and-neck cancer: the impact of region of interest selection on the intra- and interpatient variability of pharmacokinetic parameters. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):e345-50. doi: 10.1016/j.ijrobp.2011.05.059. Epub 2011 Oct 8.
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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.
David M Brizel, MD principal investigator
Department of Radiation Oncology; Duke University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Chemoradiotherapy, Cisplatin and Bevacizumab in people with Head and Neck Cancer and Pharynx Cancer, run by David M. Brizel, MD 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 9 inclusion and 22 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 18 Jan 2013. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 31 Aug 2011). 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?
Tumor Resolution (time frame: Within 30 days of completing RT). 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 NCT00140556, which also lists 8 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 18 Jan 2013.