Lung CancerPhase 2NCT00045617
S0122: Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Limited-Stage Small Cell Lung Cancer
A Phase 2 study testing monoclonal antibody 11D10 anti-idiotype vaccine, monoclonal antibody GD2 anti-idiotype vaccine and cisplatin in people with Lung Cancer, run by SWOG Cancer Research Network at 100 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- monoclonal antibody 11D10 anti-idiotype vaccine, monoclonal antibody GD2 anti-idiotype vaccine and cisplatin
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 100 sitesin 2 countries
- Study dates
- Jan 2003to May 2003
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)
- Evidence of disease by CT scan of the chest
- Measurable or evaluable disease outside of area of prior surgical resection
- No malignant pericardial or pleural effusions (cytologically positive effusions or exudative effusions not attributable to other etiologies)
- No CNS disease by chest CT scan or MRI
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Not specified
Renal
- Creatinine no greater than upper limit of normal OR
- Creatinine clearance at least 60 mL/min
Other
- No prior hypersensitivity or contraindication to monoclonal antibody 11D10 anti-idiotype vaccine (TriAb), monoclonal antibody GD2 anti-idiotype vaccine (TriGem), or aluminum hydroxide
- No known sensitivity to rodent proteins (i.e., anti-OKT-3, ONCOSCINT scan)
- No grade 1 or greater symptomatic sensory neuropathy
- No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in complete remission, or any other cancer for which patient has been disease free for 5 years
- If significant clinical hearing loss already present, must accept risk of further hearing loss
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for SCLC
- No prior TriAb or TriGem
- No prior murine antibodies
- No prior mouse proteins
- At least 30 days since prior immunotherapy
- At least 30 days since any prior immunization
Chemotherapy
- No prior systemic chemotherapy for SCLC
- No concurrent cyclophosphamide or methotrexate
Endocrine therapy
- At least 30 days since prior systemic corticosteroids
- No concurrent systemic corticosteroids (except as an antiemetic)
Radiotherapy
- No prior radiotherapy to the thorax or neck region
- No concurrent intensity modulated radiotherapy
Surgery
- See Disease Characteristics
- At least 2 weeks since prior thoracic or other major surgery and recovered
Other
- At least 30 days since prior investigational agents or devices
- No other concurrent investigational agents
- No other concurrent immunosuppressants (e.g., cyclosporine)
- No concurrent chronic systemic antihistamines
- No concurrent amifostine
Trial locations and contacts
100 sites in 2 countries.
100 sites in 2 countries
United States99 sites
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0912
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
University of Colorado Health Science Center
Aurora, Colorado, 80010-0510
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
Boston Medical Center
Boston, Massachusetts, 02118
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-W227
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
Barrett Cancer Center
Cincinnati, Ohio, 45267-0501
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001
CCOP - Columbus
Columbus, Ohio, 43206
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
CCOP - Central Illinois
Decatur, Illinois, 62526
University of Colorado Cancer Center
Denver, Colorado, 80010
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
Henry Ford Hospital
Detroit, Michigan, 48202
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
University of Texas Medical Branch
Galveston, Texas, 77555-0565
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
CCOP - Greenville
Greenville, South Carolina, 29615
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813-2424
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095
Veterans Affairs Medical Center - Houston
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
CCOP - Kansas City
Kansas City, Missouri, 64131
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576
CCOP - Dayton
Kettering, Ohio, 45429
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
Loyola University Medical Center
Maywood, Illinois, 60153-5500
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
Chao Family Comprehensive Cancer Center
Orange, California, 92868
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, 85012
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
CCOP - Columbia River Program
Portland, Oregon, 97225
Oregon Cancer Institute
Portland, Oregon, 97239
University of Rochester Medical Center
Rochester, New York, 14642
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
University of California Davis Cancer Center
Sacramento, California, 95817
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7845
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
University of Washington School of Medicine
Seattle, Washington, 98195-6527
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
St. Louis University Health Sciences Center
St Louis, Missouri, 63110
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
CCOP - Northwest
Tacoma, Washington, 98405-0986
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
CCOP - Scott and White Hospital
Temple, Texas, 76508
David Grant Medical Center
Travis Air Force Base, California, 94535
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
Arizona Cancer Center
Tucson, Arizona, 85724
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
CCOP - Wichita
Wichita, Kansas, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241
Canada1 site
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase II Trial of Patients With Limited Stage Small Cell Lung Cancer Treated With Thoracic Radiation Therapy and Chemotherapy With Cisplatin/Etoposide Followed by Cisplatin/Etoposide and Anti-Idiotype Monoclonal Antibody Vaccines
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining chemotherapy and radiation therapy with vaccine therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with vaccine therapy in treating patients who have limited-stage small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of cisplatin, etoposide, and thoracic radiotherapy followed by cisplatin, etoposide, monoclonal antibody 11D10 anti-idiotype vaccine (TriAb), and monoclonal antibody GD2 anti-idiotype vaccine (TriGem), in terms of overall and progression-free survival of patients with limited stage small cell lung cancer.
- Determine the immune response to each of the 2 anti-idiotype vaccines when used in this regimen in these patients.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Determine the response rates (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Thoracic radiotherapy is administered 5 days a week, beginning on day 1 of chemotherapy, for 5 weeks. Patients then undergo radiotherapy boost for 1.5 weeks.
Patients with stable disease or at least partial response proceed to consolidation therapy.
- Consolidation therapy (begins within 3-5 weeks of the last dose of induction chemotherapy or radiotherapy): Patients receive cisplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14. Patients also receive monoclonal antibody 11D10 anti-idiotype vaccine (TriAb) and monoclonal antibody GD2 anti-idiotype vaccine (TriGem) intradermally on day 1 of weeks 11, 13, 15, and 17 (4 injections) and then monthly subcutaneously for 2 years. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients who achieve complete response after consolidation chemotherapy undergo cranial radiotherapy 5 days a week for 3 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.
- Conditions
- Lung Cancer
- Being tested
- monoclonal antibody 11D10 anti-idiotype vaccine, monoclonal antibody GD2 anti-idiotype vaccine, cisplatin, etoposide, radiation therapy
- Keywords
- limited stage small cell lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monoclonal antibody 11D10 anti-idiotype vaccineBiological
monoclonal antibody GD2 anti-idiotype vaccineBiological
cisplatinDrug
etoposideDrug
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| cisplatin and etoposide followed by vaccine | Experimental | standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine Receives: Biological: monoclonal antibody 11D10 anti-idiotype vaccine; Biological: monoclonal antibody GD2 anti-idiotype vaccine; Drug: cisplatin; Drug: etoposide; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
time from date of registration to date of death
Measured: up to 5 years
Secondary outcomes (3)
immune response
T-cell proliferation and HAMA testing
Measured: at Week 10
toxicity assessment
assessment of qualitative and quantitative toxicities
Measured: 22 weeks
response
RECIST partial and complete response
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2003
- Primary completionMay 2003
- Study completionMay 2003
Why it stopped: Closed due to lack of drug availability.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Abdul-Rahman Jazieh, MD, MPH, Study chair, Barrett Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045617
- Sponsor's protocol ID
- CDR0000256922
- Other IDs
- S0122, U10CA032102
- Status last verified
- Jun 2012
- First submitted
- 6 Sep 2002
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Patients With Limited Stage Small Cell Lung Cancer Treated With Thoracic Radiation Therapy and Chemotherapy With Cisplatin/Etoposide Followed by Cisplatin/Etoposide and Anti-Idiotype Monoclonal Antibody Vaccines
- ClinicalTrials.gov ID
- NCT00045617
- Acronym / sponsor ID
- CDR0000256922
- Conditions
- Lung Cancer
- Keywords
- limited stage small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to lack of drug availability.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2003
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining chemotherapy and radiation therapy with vaccine therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with vaccine therapy in treating patients who have limited-stage small cell lung cancer.
Detailed description
OBJECTIVES:
- Determine the efficacy of cisplatin, etoposide, and thoracic radiotherapy followed by cisplatin, etoposide, monoclonal antibody 11D10 anti-idiotype vaccine (TriAb), and monoclonal antibody GD2 anti-idiotype vaccine (TriGem), in terms of overall and progression-free survival of patients with limited stage small cell lung cancer.
- Determine the immune response to each of the 2 anti-idiotype vaccines when used in this regimen in these patients.
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Determine the response rates (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Thoracic radiotherapy is administered 5 days a week, beginning on day 1 of chemotherapy, for 5 weeks. Patients then undergo radiotherapy boost for 1.5 weeks.
Patients with stable disease or at least partial response proceed to consolidation therapy.
- Consolidation therapy (begins within 3-5 weeks of the last dose of induction chemotherapy or radiotherapy): Patients receive cisplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14. Patients also receive monoclonal antibody 11D10 anti-idiotype vaccine (TriAb) and monoclonal antibody GD2 anti-idiotype vaccine (TriGem) intradermally on day 1 of weeks 11, 13, 15, and 17 (4 injections) and then monthly subcutaneously for 2 years. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients who achieve complete response after consolidation chemotherapy undergo cranial radiotherapy 5 days a week for 3 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cisplatin and etoposide followed by vaccine | Experimental | Biological: monoclonal antibody 11D10 anti-idiotype vaccine, Biological: monoclonal antibody GD2 anti-idiotype vaccine, Drug: cisplatin, Drug: etoposide, Radiation: radiation therapystandard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| monoclonal antibody 11D10 anti-idiotype vaccine | Biological | cisplatin and etoposide followed by vaccine |
| monoclonal antibody GD2 anti-idiotype vaccine | Biological | cisplatin and etoposide followed by vaccine |
| cisplatin | Drug | cisplatin and etoposide followed by vaccine |
| etoposide | Drug | cisplatin and etoposide followed by vaccine |
| radiation therapy | Radiation | cisplatin and etoposide followed by vaccine |
Primary outcome
overall survival
Time frame: up to 5 years
time from date of registration to date of death
3 secondary outcomes
immune response
Time frame: at Week 10
toxicity assessment
Time frame: 22 weeks
response
Time frame: 25 weeks
Results and safety
The study was stopped early (reason given: Closed due to lack of drug availability.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
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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.
Abdul-Rahman Jazieh, MD, MPH study chair
Barrett Cancer Center
100 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing monoclonal antibody 11D10 anti-idiotype vaccine, monoclonal antibody GD2 anti-idiotype vaccine and cisplatin in people with Lung Cancer, run by SWOG Cancer Research Network at 100 sites in 2 countries.
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 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States, Canada. 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 stopped early (reason given: Closed due to lack of drug availability.). Results are not available in the source record.
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?
overall survival (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 13 Jun 2012.