Stage II Lymphoepithelioma of the NasopharynxPhase 2NCT00896181
Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)
A Phase 2 study testing docetaxel, cisplatin and carboplatin in people with Stage II Lymphoepithelioma of the Nasopharynx and Stage II Squamous Cell Carcinoma of the Nasopharynx, run by Stanford University at 1 site in United States.
Trial summary
This phase 2 trial is studying whether giving a combination of docetaxel, cisplatin, and fluorouracil chemotherapy followed by the combination of cisplatin with radiation therapy works in treating patients with advanced nasopharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Stage II Lymphoepithelioma of the Nasopharynx, Stage II Squamous Cell Carcinoma of the Nasopharynx, Stage III Lymphoepithelioma of the Nasopharynx
- What is being tested?
- docetaxel, cisplatin 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
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2008to Dec 2020
- Phase
- Phase 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
Who may be able to join
- Histologically- or cytologically-confirmed nasopharyngeal carcinoma meeting the following criteria:
- WHO type I, II, or III
- Stage II to IVB disease (minimally T2a, N0, M0 or any T any, N1, M0)
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
- Prior diagnostic surgery(s) at the primary site or neck allowed provided there is still measurable disease present
- Without known brain metastases
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- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Life expectancy > 3 months
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 times ULN
- Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 55 mL/min (NOTE: * Patients with creatinine > grade 1 but < grade 3, hearing loss ≥ grade 2, and peripheral neuropathy ≥ grade 2 are eligible provided they receive carboplatin in place of cisplatin throughout study treatment)
- Hearing loss < grade 2. Hearing loss grade 2 or greater attributable to tumor obstruction, when the bone conduction in the audiogram is consistent with less than grade 2, is permissible for cisplatin. Hearing loss will be evaluated by hearing in the best ear. If hearing loss is grade 2, patients are still eligible but should receive carboplatin throughout the protocol instead of cisplatin.
- Peripheral motor/sensory neuropathy < grade 2. If peripheral neuropathy is grade 2, patients are still eligible but should receive carboplatin throughout the protocol instead of cisplatin.
- Fertile patients must use effective contraception prior to and during study treatment
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that preclude compliance with study requirements
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- Clinically-significant cardiovascular disease
- Cerebrovascular accident within the past 6 months
- Myocardial infarction or unstable angina within the past 6 months
- New York Heart Association (NYHA) class II to IV congestive heart failure
- Serious and inadequately controlled cardiac arrhythmia
- Significant vascular disease (eg, aortic aneurysm, history of aortic dissection)
- Clinically-significant peripheral vascular disease
- History of allergic reaction attributed to compounds of similar chemical or biologic composition to docetaxel, cisplatin, carboplatin, fluorouracil, bevacizumab, or other agents used in this study
- Known brain metastases
- Concurrent combination antiretroviral therapy for HIV-positive patients
- Prior chemotherapy or radiotherapy for nasopharyngeal carcinoma
- Pregnant or nursing
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: A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)
This phase 2 trial is studying whether giving a combination of docetaxel, cisplatin, and fluorouracil chemotherapy followed by the combination of cisplatin with radiation therapy works in treating patients with advanced nasopharyngeal cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized 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. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVE:
- To establish the progression free survival rate at 2 years, using RECIST criteria, to induction treatment with docetaxel, cisplatin, and fluorouracil (TPF) followed by chemoradiotherapy of locoregionally advanced nasopharyngeal carcinoma (NPC)
SECONDARY OBJECTIVE:
- To evaluate complete response rates, safety and feasibility of TPF followed by chemoradiation in patients with NPC
OUTLINE: This is a single site study.
INDUCTION THERAPY: Patients receive docetaxel intravenously (IV) over 60 minutes on Day 1; cisplatin IV over 1 to 3 hours (or carboplatin IV over 30 minutes) on Day 1; and fluorouracil IV continuously over 24 hours on Days 1 to 5. Each cycle is 21 days, with treatment consisting of up to 3 cycles in the absence of disease progression or unacceptable toxicity.
CONCURRENT CHEMO-RADIOTHERAPY: Beginning within 3 to 6 weeks after initiating the last course of induction chemotherapy, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily for 6.5 to 7 weeks. Patients also receive cisplatin IV over 1 hour (or carboplatin IV over 30 minutes) once weekly in weeks 1 to 6 in the absence of disease progression or unacceptable toxicity.
All study treatment is admininstered over the course of 21 weeks. After completion of study treatment, patients are followed periodically for 24 months.
- Conditions
- 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
- Being tested
- docetaxel, cisplatin, carboplatin, fluorouracil, 3-dimensional conformal radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Also called RP 56976, Taxotere, TXT
Given IV
cisplatinDrug
Also called CACP, CDDP, CPDD, DDP
Given IV
carboplatinDrug
Also called Carboplat, CBDCA, JM-8, Paraplat
Given IV
fluorouracilDrug
Also called 5-fluorouracil, 5-Fluracil, 5-FU
Given IV
3-dimensional conformal radiation therapyRadiation
Also called 3D conformal radiation therapy, 3D-CRT
Undergo 3-dimensional conformal or intensity-modulated radiotherapy
intensity-modulated radiation therapyRadiation
Also called IMRT
Undergo 3-dimensional conformal or intensity-modulated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiation for Nasopharyngeal Carcinoma | Experimental | INDUCTION THERAPY: Patients receive docetaxel intravenously (IV) over 60 minutes on Day 1; cisplatin IV over 1 to 3 hours (or carboplatin IV over 30 minutes) on Day 1; and fluorouracil IV continuously over 24 hours on Days 1 to 5. Each cycle is 21 days, with treatment consisting of up to 3 cycles in the absence of disease progression or unacceptable toxicity.
CONCURRENT CHEMO-RADIOTHERAPY: Beginning within 3 to 6 weeks after initiating the last course of induction chemotherapy, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily for 6.5 to 7 weeks. Patients also receive cisplatin IV over 1 hour (or carboplatin IV over 30 minutes) once weekly in weeks 1 to 6 in the absence of disease progression or unacceptable toxicity. Receives: Drug: docetaxel; Drug: cisplatin; Drug: carboplatin; Drug: fluorouracil; Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progression-free Survival (PFS) at 2 Years After Chemo-radiotherapy
Progression-free survival (PFS) means to remain alive without disease progression. Progression is defined as either the appearance of one or more new cancer lesions, or a ≥ 20% increase in the sum of the longest diameters (LD) of target cancer lesions, compared the same measurement obtained at the start of treatment. This outcome reported as the number of patients remaining alive at 2 years following chemo-radiotherapy without disease progression, a number without dispersion.
Measured: up to 29 months (ie, 24 months post-chemoradiation)
Median Progression-free Survival (PFS)
Progression-free survival (PFS) means to remain alive without disease progression. Progression is defined as either the appearance of one or more new cancer lesions, or a ≥ 20% increase in the sum of the longest diameters (LD) of target cancer lesions, compared the same measurement obtained at the start of treatment. This outcome reported as the median duration of PFS in months since chemo-radiotherapy, with full range.
Measured: up to 127 months (includes treatment period of up to 5 months)
Secondary outcomes (3)
Overall Survival (OS)
Overall survival (OS) was assessed as the duration of time that study participants remained alive after chemoradiotherapy. The outcome is reported as median OS (with full range).
Measured: up to 127 months (includes treatment period of up to 5 months)
Number of Participants With Adverse Events Resulting in Treatment Discontinuation
Adverse events during treatment were assessed as whether they were definitely-, probably-, or possibly-related to protocol treatment (ie, adverse reaction). The outcome is reported as the number of participants who discontinued treatment due to an adverse reaction.
Measured: 8 months
Number of Participants With Treatment Response
Participants who completed 1 cycle of docetaxel, cisplatin, and 5-fluorouracil (TPF) were evaluated for response. Response was assessed for lesions designated as target (TL) and non-target (NTL) as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The outcome is reported as a number without dispersion.
TL Criterion:
- CR: Disappearance of lesions
- PR: 30% decrease in the sum of the longest diameter (LD) of lesions
- PD: 20% increase in the sum of the LD of lesions, or any new lesion
- SD: Neither sufficient shrinkage for PR nor sufficient increase for PD
NTL Criterion:
- CR: Disappearance of lesions and normalization of tumor marker level
- PR / SD: Persistence of one or more lesion(s) and/or maintenance of tumor marker level above the normal limits (includes "incomplete response / PR).
- PD: Appearance of one or more new lesions and/or unequivocal progression of existing lesions.
Measured: up to 29 months (ie, 24 months post-chemoradiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study start10 Dec 2008
- Primary completion3 Jan 2020
- Study completionDec 2020
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 Stage II Lymphoepithelioma of the NasopharynxStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Dimitrios Colevas, Stanford University
- Investigators
- Alexander Colevas, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896181
- Sponsor's protocol ID
- IRB-15411
- Other IDs
- NCI-2009-01162, CDR0000671087, 8209, ENT0025
- Status last verified
- Mar 2021
- First submitted
- 7 May 2009
- Last updated
- 6 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jun M, Pinto H, Le QT, Quon A, Hara W, Coty J, McMillan A, Lu R, Winters E, Lira R, Colevas AD. In search for optimal induction chemotherapy for advanced nasopharyngeal cancer: Standard dosing of Docetaxel, Platinum, and 5-Fluorouracil (TPF) followed by chemoradiation. PLoS One. 2023 Feb 2;18(2):e0276651. doi: 10.1371/journal.pone.0276651. eCollection 2023.
PubMed 36730145
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)
- ClinicalTrials.gov ID
- NCT00896181
- Acronym / sponsor ID
- IRB-15411
- Conditions
- 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 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 10 Dec 2008 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 11 May 2009 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2 trial is studying whether giving a combination of docetaxel, cisplatin, and fluorouracil chemotherapy followed by the combination of cisplatin with radiation therapy works in treating patients with advanced nasopharyngeal cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized 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. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVE:
- To establish the progression free survival rate at 2 years, using RECIST criteria, to induction treatment with docetaxel, cisplatin, and fluorouracil (TPF) followed by chemoradiotherapy of locoregionally advanced nasopharyngeal carcinoma (NPC)
SECONDARY OBJECTIVE:
- To evaluate complete response rates, safety and feasibility of TPF followed by chemoradiation in patients with NPC
OUTLINE: This is a single site study.
INDUCTION THERAPY: Patients receive docetaxel intravenously (IV) over 60 minutes on Day 1; cisplatin IV over 1 to 3 hours (or carboplatin IV over 30 minutes) on Day 1; and fluorouracil IV continuously over 24 hours on Days 1 to 5. Each cycle is 21 days, with treatment consisting of up to 3 cycles in the absence of disease progression or unacceptable toxicity.
CONCURRENT CHEMO-RADIOTHERAPY: Beginning within 3 to 6 weeks after initiating the last course of induction chemotherapy, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily for 6.5 to 7 weeks. Patients also receive cisplatin IV over 1 hour (or carboplatin IV over 30 minutes) once weekly in weeks 1 to 6 in the absence of disease progression or unacceptable toxicity.
All study treatment is admininstered over the course of 21 weeks. After completion of study treatment, patients are followed periodically for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoradiation for Nasopharyngeal Carcinoma | Experimental | Drug: docetaxel, Drug: cisplatin, Drug: carboplatin, Drug: fluorouracil, Radiation: 3-dimensional conformal radiation therapy, Radiation: intensity-modulated radiation therapyINDUCTION THERAPY: Patients receive docetaxel intravenously (IV) over 60 minutes on Day 1; cisplatin IV over 1 to 3 hours (or carboplatin IV over 30 minutes) on Day 1; and fluorouracil IV continuously over 24 hours on Days 1 to 5. Each cycle is 21 days, with treatment consisting of up to 3 cycles in the absence of disease progression or unacceptable toxicity. CONCURRENT CHEMO-RADIOTHERAPY: Beginning within 3 to 6 weeks after initiating the last course of induction chemotherapy, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily for 6.5 to 7 weeks. Patients also receive cisplatin IV over 1 hour (or carboplatin IV over 30 minutes) once weekly in weeks 1 to 6 in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically- or cytologically-confirmed nasopharyngeal carcinoma meeting the following criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Life expectancy > 3 months
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
Key exclusion criteria (18 listed)
- Uncontrolled intercurrent illness including, but not limited to, any of the following:
- History of allergic reaction attributed to compounds of similar chemical or biologic composition to docetaxel, cisplatin, carboplatin, fluorouracil, bevacizumab, or other agents used in this study
- Known brain metastases
- Concurrent combination antiretroviral therapy for HIV-positive patients
- Prior chemotherapy or radiotherapy for nasopharyngeal carcinoma
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 |
|---|---|---|
| docetaxelAlso: RP 56976, Taxotere, TXTGiven IV | Drug | Chemoradiation for Nasopharyngeal Carcinoma |
| cisplatinAlso: CACP, CDDP, CPDD, DDPGiven IV | Drug | Chemoradiation for Nasopharyngeal Carcinoma |
| carboplatinAlso: Carboplat, CBDCA, JM-8, ParaplatGiven IV | Drug | Chemoradiation for Nasopharyngeal Carcinoma |
| fluorouracilAlso: 5-fluorouracil, 5-Fluracil, 5-FUGiven IV | Drug | Chemoradiation for Nasopharyngeal Carcinoma |
| 3-dimensional conformal radiation therapyAlso: 3D conformal radiation therapy, 3D-CRTUndergo 3-dimensional conformal or intensity-modulated radiotherapy | Radiation | Chemoradiation for Nasopharyngeal Carcinoma |
| intensity-modulated radiation therapyAlso: IMRTUndergo 3-dimensional conformal or intensity-modulated radiotherapy | Radiation | Chemoradiation for Nasopharyngeal Carcinoma |
Primary outcome
Number of Participants With Progression-free Survival (PFS) at 2 Years After Chemo-radiotherapy
Time frame: up to 29 months (ie, 24 months post-chemoradiation)
Progression-free survival (PFS) means to remain alive without disease progression. Progression is defined as either the appearance of one or more new cancer lesions, or a ≥ 20% increase in the sum of the longest diameters (LD) of target cancer lesions, compared the same measurement obtained at the start of treatment. This outcome reported as the number of patients remaining alive at 2 years following chemo-radiotherapy without disease progression, a number without dispersion.
Median Progression-free Survival (PFS)
Time frame: up to 127 months (includes treatment period of up to 5 months)
Progression-free survival (PFS) means to remain alive without disease progression. Progression is defined as either the appearance of one or more new cancer lesions, or a ≥ 20% increase in the sum of the longest diameters (LD) of target cancer lesions, compared the same measurement obtained at the start of treatment. This outcome reported as the median duration of PFS in months since chemo-radiotherapy, with full range.
3 secondary outcomes
Overall Survival (OS)
Time frame: up to 127 months (includes treatment period of up to 5 months)
Number of Participants With Adverse Events Resulting in Treatment Discontinuation
Time frame: 8 months
Number of Participants With Treatment Response
Time frame: up to 29 months (ie, 24 months post-chemoradiation)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36730145Jun M, Pinto H, Le QT, Quon A, Hara W, Coty J, McMillan A, Lu R, Winters E, Lira R, Colevas AD. In search for optimal induction chemotherapy for advanced nasopharyngeal cancer: Standard dosing of Docetaxel, Platinum, and 5-Fluorouracil (TPF) followed by chemoradiation. PLoS One. 2023 Feb 2;18(2):e0276651. doi: 10.1371/journal.pone.0276651. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Alexander Colevas principal investigator
Stanford University Hospitals and Clinics
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 docetaxel, cisplatin and carboplatin in people with Stage II Lymphoepithelioma of the Nasopharynx and Stage II Squamous Cell Carcinoma of the Nasopharynx, run by Stanford University 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 16 inclusion and 18 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 6 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2021). 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?
Number of Participants With Progression-free Survival (PFS) at 2 Years After Chemo-radiotherapy (time frame: up to 29 months (ie, 24 months post-chemoradiation)). 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 NCT00896181, 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 6 Apr 2021.