Stage III Squamous Cell Carcinoma of the OropharynxPhase 2NCT01953952
Radiation Therapy and Cisplatin With or Without Surgery in Treating Patients With Stage III-IV Oropharyngeal Cancer
A Phase 2 study testing therapeutic conventional surgery, intensity-modulated radiation therapy and cisplatin in people with Stage III Squamous Cell Carcinoma of the Oropharynx and Stage IVA Squamous Cell Carcinoma of the Oropharynx, run by Radiation Therapy Oncology Group at 1 site in United States.
Trial summary
This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Tongue Cancer
- What is being tested?
- therapeutic conventional surgery, intensity-modulated radiation therapy and cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, localized to the tonsil, glossopharyngeal sulcus, and tongue-base within 6 weeks (42 days) of registration
- The primary tumor must be resectable through a transoral endoscopic head and neck surgery with anticipation of resection free margins (resection does not require total or subtotal glossectomy or total laryngectomy); specifically, patients must (1) not have trismus, (2) not have interincisor opening less than 2.5 cm, and (3) not have poor transoral exposure of the tumor itself nor surrounding soft-tissue margins, regardless of etiology
- Clinical stage III-IV; T1-2, N1-2b; T3, N0-2b, with only well-lateralized exophytic T3 tumors not approaching within 1 cm of midline, and amenable to transoral eHNS
- p16 protein (p16) negative by immunohistochemistry (documented by the institution's pre-enrollment biomarker screening at a Clinical Laboratory Improvement Amendments [CLIA]-certified lab), defined as absent, weak, and/or only focal nuclear and cytoplasmic staining in less than 70% of the tumor cells
- Appropriate stage for protocol entry, including no distant metastases or adenopathy below the clavicles, based upon the following minimum diagnostic workup:
- History/physical examination by the treating physician (radiation oncologist, medical oncologist, or head and neck surgeon) within 30 days prior to registration
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- Imaging of the head and neck (CT with contrast, positron emission tomography [PET]/CT, and/or magnetic resonance imaging [MRI]) within 30 days prior to registration; a CT scan with contrast is mandatory (unless contraindicated, e.g. contrast allergy, etc.); note that a PET/CT scan alone (unless performed with contrast) is not sufficient
- Chest CT scan (with or without contrast) or PET/CT of chest (with or without contrast) within 30 days prior to registration
- Modified barium swallow (MBS) to assess swallowing function within 30 days prior to registration
- Preoperative Mallampati assessment as documented by attending surgeon within 30 days prior to registration
- Zubrod performance status 0-1 within 30 days prior to registration
- Absolute neutrophil count (ANC) >= 1,800 cells/mm^3 based upon complete blood count (CBC)/differential
- Platelets >= 100,000 cells/mm^3 based upon CBC/differential
- Hemoglobin >= 8.0 g/dl based upon CBC/differential (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
- Total bilirubin =< 2 mg/dl
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the upper limit of normal
- Serum creatinine =< 1.5 mg/dl and/or creatinine clearance (CC) >= 50 ml/min; CC can be determined by 24-hour collection or estimated by Cockcroft-Gault formula
- Serum pregnancy test within 14 days prior to registration for women of childbearing potential
- Women of childbearing potential and male participants who are sexually active must practice medically effective contraception during treatment and for 42 days following completion of treatment
- Patient must be able to provide study-specific informed consent prior to study entry
Who cannot join
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast or cervix are all permissible)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active co-morbidity, defined as follows:
- > 2 based on the American Society of Anesthesiologists (ASA) physical status classification system
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
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- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immuno-compromised patients
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
- Prior allergic reaction to cisplatin
- Radiographic evidence of retropharyngeal metastasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospitals and Clinics
Stanford, California, 94305
About this study
Official title: Randomized Phase II Trial of Transoral Endoscopic Head And Neck Surgery Followed by Risk-Based IMRT and Weekly Cisplatin Versus IMRT and Weekly Cisplatin for HPV Negative Oropharynx Cancer
This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if primary treatment with transoral endoscopic head and neck surgery will improve progression free survival (PFS) for patients with human papilloma virus negative (HPV-) oropharyngeal cancer (OPC).
SECONDARY OBJECTIVES:
- To compare patterns of failure (local-regional relapse versus distant) and survival (overall and progression-free).
II. To determine the safety and efficacy (rate of positive surgical margins) of using transoral robotic surgery for patients with T3 tumors of the tonsil, tongue-base, or glossopharyngeal sulcus.
III. To compare head and neck cancer-specific quality of life (QOL) short-term (< 6 months) and long-term (2 years) relating to swallowing function.
IV. To compare subjective (patient reported) and objective (physiologic) measures of swallowing function short-term and long-term.
- To assess effect of neck dissection on shoulder function using a validated QOL instrument for patients undergoing neck dissection VI. To assess the correlation of physician derived clinical target volumes (CTV's) with locoregional control or failure.
VII. To determine whether specific molecular profiles are associated with overall or progression-free survival or other clinical endpoints.
VIII. To determine the sensitivity and specificity of pre-treatment computed tomography (CT) scans detecting the presence of lymph node extracapsular extension by examining the surgically dissected lymph nodes.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo transoral endoscopic head and neck surgery (eHNS). Depending on post-operative pathology findings, patients may undergo intensity modulated radiation therapy (IMRT) once daily (QD) five days a week for 6 weeks. High-risk patients also receive cisplatin intravenously (IV) on days 1, 8, 15, 22, 29, and 36 during radiation therapy.
ARM II: Patients undergo IMRT QD five days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
- Conditions
- Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Tongue Cancer
- Being tested
- therapeutic conventional surgery, intensity-modulated radiation therapy, cisplatin, quality-of-life assessment, laboratory biomarker analysis
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic conventional surgeryProcedure or surgery
Undergo transoral eHNS
intensity-modulated radiation therapyRadiation
Also called IMRT
Undergo IMRT
cisplatinDrug
Also called CACP, CDDP, CPDD, DDP
Given IV
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (surgery, risk-based adjuvant therapy) | Experimental | Patients undergo eHNS. Depending on post-operative pathology findings, patients may undergo IMRT QD five days a week for 6 weeks, beginning within 6 weeks after surgery. High-risk patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy. Receives: Procedure: therapeutic conventional surgery; Radiation: intensity-modulated radiation therapy; Drug: cisplatin; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
| Arm II (chemoradiotherapy) | Active comparator | Patients undergo IMRT QD five days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy. Receives: Radiation: intensity-modulated radiation therapy; Drug: cisplatin; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Estimated for both arms using the Kaplan-Meier method. The distribution will be compared between arms with a one-sided log rank test.
Measured: Up to 5 years
Secondary outcomes (7)
Patterns of local, regional, and distant failure
The cumulative incidence method will be used to estimate local-regional and distant failure rates and the failure rates for the experimental treatment will be compared against the control using a failure specific log rank test.
Measured: Up to 5 years
Overall survival (OS)
Estimated for both arms using the Kaplan-Meier method. The distribution will be compared between arms with a one-sided log rank test.
Measured: Up to 5 years
Rate of grade 4-5 oropharyngeal hemorrhage and involved surgical margin for all patients and patients with selected T3 tumors
Measured: Up to 5 years
Objective swallowing function
Measured: Up to 2 years
Shoulder function
Measured: Up to 2 years
Short-term quality of life: head and neck-specific (swallowing domain and shoulder function) using the M. D. Anderson Dysphagia Inventory (MDADI)
Compared using a two-sample independent t test and paired t test if the comparison is within the experimental arm between different time points. Overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm. Binary endpoints will be compared using Fisher's exact test.
Measured: Up to 6 months
Long-term quality of life: head and neck-specific (swallowing domain and shoulder function) using the MDADI
Compared using a two-sample independent t test and paired t test if the comparison is within the experimental arm between different time points. Overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm. Binary endpoints will be compared using Fisher's exact test.
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Squamous Cell Carcinoma of the OropharynxStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Responsible party
- Sponsor
- Investigators
- Floyd C. Holsinger, Principal investigator, Radiation Therapy Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953952
- Sponsor's protocol ID
- RTOG 1221
- Other IDs
- NCI-2013-00939, RTOG 1221, RTOG-1221, U10CA021661
- Status last verified
- Mar 2015
- First submitted
- 26 Sep 2013
- Last updated
- 20 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Transoral Endoscopic Head And Neck Surgery Followed by Risk-Based IMRT and Weekly Cisplatin Versus IMRT and Weekly Cisplatin for HPV Negative Oropharynx Cancer
- ClinicalTrials.gov ID
- NCT01953952
- Acronym / sponsor ID
- RTOG 1221
- Conditions
- Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Tongue Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), NRG Oncology
- Study start
- Dec 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies radiation therapy and cisplatin with or without surgery in treating patients with stage III-IV oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with radiation therapy may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without surgery in treating patients with oropharyngeal cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine if primary treatment with transoral endoscopic head and neck surgery will improve progression free survival (PFS) for patients with human papilloma virus negative (HPV-) oropharyngeal cancer (OPC).
SECONDARY OBJECTIVES:
- To compare patterns of failure (local-regional relapse versus distant) and survival (overall and progression-free).
II. To determine the safety and efficacy (rate of positive surgical margins) of using transoral robotic surgery for patients with T3 tumors of the tonsil, tongue-base, or glossopharyngeal sulcus.
III. To compare head and neck cancer-specific quality of life (QOL) short-term (< 6 months) and long-term (2 years) relating to swallowing function.
IV. To compare subjective (patient reported) and objective (physiologic) measures of swallowing function short-term and long-term.
- To assess effect of neck dissection on shoulder function using a validated QOL instrument for patients undergoing neck dissection VI. To assess the correlation of physician derived clinical target volumes (CTV's) with locoregional control or failure.
VII. To determine whether specific molecular profiles are associated with overall or progression-free survival or other clinical endpoints.
VIII. To determine the sensitivity and specificity of pre-treatment computed tomography (CT) scans detecting the presence of lymph node extracapsular extension by examining the surgically dissected lymph nodes.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo transoral endoscopic head and neck surgery (eHNS). Depending on post-operative pathology findings, patients may undergo intensity modulated radiation therapy (IMRT) once daily (QD) five days a week for 6 weeks. High-risk patients also receive cisplatin intravenously (IV) on days 1, 8, 15, 22, 29, and 36 during radiation therapy.
ARM II: Patients undergo IMRT QD five days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (surgery, risk-based adjuvant therapy) | Experimental | Procedure: therapeutic conventional surgery, Radiation: intensity-modulated radiation therapy, Drug: cisplatin, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients undergo eHNS. Depending on post-operative pathology findings, patients may undergo IMRT QD five days a week for 6 weeks, beginning within 6 weeks after surgery. High-risk patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy. |
| Arm II (chemoradiotherapy) | Active comparator | Radiation: intensity-modulated radiation therapy, Drug: cisplatin, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients undergo IMRT QD five days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, localized to the tonsil, glossopharyngeal sulcus, and tongue-base within 6 weeks (42 days) of registration
- The primary tumor must be resectable through a transoral endoscopic head and neck surgery with anticipation of resection free margins (resection does not require total or subtotal glossectomy or total laryngectomy); specifically, patients must (1) not have trismus, (2) not have interincisor opening less than 2.5 cm, and (3) not have poor transoral exposure of the tumor itself nor surrounding soft-tissue margins, regardless of etiology
- Clinical stage III-IV; T1-2, N1-2b; T3, N0-2b, with only well-lateralized exophytic T3 tumors not approaching within 1 cm of midline, and amenable to transoral eHNS
- p16 protein (p16) negative by immunohistochemistry (documented by the institution's pre-enrollment biomarker screening at a Clinical Laboratory Improvement Amendments [CLIA]-certified lab), defined as absent, weak, and/or only focal nuclear and cytoplasmic staining in less than 70% of the tumor cells
- Appropriate stage for protocol entry, including no distant metastases or adenopathy below the clavicles, based upon the following minimum diagnostic workup:
Key exclusion criteria (14 listed)
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast or cervix are all permissible)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active co-morbidity, defined as follows:
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
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 |
|---|---|---|
| therapeutic conventional surgeryUndergo transoral eHNS | Procedure or surgery | Arm I (surgery, risk-based adjuvant therapy) |
| intensity-modulated radiation therapyAlso: IMRTUndergo IMRT | Radiation | Arm I (surgery, risk-based adjuvant therapy), Arm II (chemoradiotherapy) |
| cisplatinAlso: CACP, CDDP, CPDD, DDPGiven IV | Drug | Arm I (surgery, risk-based adjuvant therapy), Arm II (chemoradiotherapy) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (surgery, risk-based adjuvant therapy), Arm II (chemoradiotherapy) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (surgery, risk-based adjuvant therapy), Arm II (chemoradiotherapy) |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 5 years
Estimated for both arms using the Kaplan-Meier method. The distribution will be compared between arms with a one-sided log rank test.
7 secondary outcomes
Patterns of local, regional, and distant failure
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Rate of grade 4-5 oropharyngeal hemorrhage and involved surgical margin for all patients and patients with selected T3 tumors
Time frame: Up to 5 years
Objective swallowing function
Time frame: Up to 2 years
Shoulder function
Time frame: Up to 2 years
Short-term quality of life: head and neck-specific (swallowing domain and shoulder function) using the M. D. Anderson Dysphagia Inventory (MDADI)
Time frame: Up to 6 months
Long-term quality of life: head and neck-specific (swallowing domain and shoulder function) using the MDADI
Time frame: At 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
Related trials for Stage III Squamous Cell Carcinoma of the Oropharynx
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Human Papilloma Virus Infection, Stage III Squamous Cell Carcinoma of the Oropharynx
Active, not recruitingPhase 2
Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer
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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.
Floyd C. Holsinger principal investigator
Radiation Therapy Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing therapeutic conventional surgery, intensity-modulated radiation therapy and cisplatin in people with Stage III Squamous Cell Carcinoma of the Oropharynx and Stage IVA Squamous Cell Carcinoma of the Oropharynx, run by Radiation Therapy Oncology Group 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 20 inclusion and 14 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: withdrawn, as of the sponsor's last update on 20 Mar 2015. 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?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression-free survival (PFS) (time frame: Up to 5 years). 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 20 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.