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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00626990
Registration number
NCT00626990
Ethics application status
Date submitted
28/02/2008
Date registered
29/02/2008
Date last updated
11/09/2023
Titles & IDs
Public title
Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
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Scientific title
Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
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Secondary ID [1]
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NCIC CTG CEC.1
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Secondary ID [2]
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EORTC-26053-22054
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Universal Trial Number (UTN)
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Trial acronym
CATNON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Brain
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Cancer
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Children's - Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - temozolomide
Treatment: Other - DNA methylation analysis
Other interventions - laboratory biomarker analysis
Treatment: Surgery - adjuvant therapy
Treatment: Surgery - quality-of-life assessment
Treatment: Other - radiation therapy
Active comparator: Radiotherapy (RT) alone - radiation therapy alone
Active comparator: RT & Concurrent CT - Radiotherapy and concurrent temozolomide chemotherapy
Active comparator: RT + Adjuvant CT - Radiotherapy plus adjuvant temozolomide chemotherapy
Active comparator: RT & Concurrent CT + adjuvant CT - Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
Treatment: Drugs: temozolomide
Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
Treatment: Other: DNA methylation analysis
O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.
Other interventions: laboratory biomarker analysis
Prognostic factor analyses
Treatment: Surgery: adjuvant therapy
Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
Treatment: Surgery: quality-of-life assessment
Quality of Life analysis will also be used to assess neurological deterioration free progression
Treatment: Other: radiation therapy
Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Intervention code [3]
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Other interventions
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Intervention code [4]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival as Measured From the Day of Randomization
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Assessment method [1]
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The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.
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Timepoint [1]
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from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)
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Secondary outcome [1]
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Progression-free Survival
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Assessment method [1]
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Disease progression is defined as radiological or neurological/clinical progression (whichever occurs first); progression free survival (PFS) is the time interval between the date of randomization and the date of disease progression or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination. Radiological progression was defined as increase of contrast enhancing area on MRI or CT scans of more than 25% as measured by two perpendicular diameters compared to the smallest measurements ever recorded for the same lesion by the same technique. The appearance of new lesions with or without contrast enhancement Neurological/clinical progression was defined as:decrease in WHO performance status,deterioration of neurological functions,appearance of signs/symptoms of increased intracranial pressure,and/or start of corticosteroid or increase of corticosteroid dosage by 50% for control of neurological symptoms.
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Timepoint [1]
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from randomization till the date of disease progression or death (time till death is up to 10.9 years after patient enrollment in the study)
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Secondary outcome [2]
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Quality of Life of the Patient
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Assessment method [2]
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Quality of life was assessed by the EORTC Quality of Life Questionnaire (QLQ-C30) version 3 and the Brain Cancer Module-20
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Timepoint [2]
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from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study)
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Secondary outcome [3]
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Neurological Deterioration Free Survival
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Assessment method [3]
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Neurological deterioration is defined as a decrease in WHO performance status as follows:
decrease in WHO performance status
* for patients with baseline WHO performance status 0: deterioration to WHO performance status 2 or worse for which no other explanation is present, and which is maintained for at least three months
* for patients with baseline WHO performance status 1 or 2: deterioration to WHO performance status 3 or worse for which no other explanation is present and which is maintained for at least three months
The date of neurological deterioration will be the first date the persistent decrease in performance status was diagnosed. Neurological deterioration free progression is the time interval between the date of randomization and the date of neurological deterioration or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination
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Timepoint [3]
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within 2 weeks of randomization; during radiotherapy at week 4 and 6; 4 weeks after the end of radiotherapy; Six monthly after the end of radiotherapy; Prior to each cycle of adjuvant therapy; Every six months after the documentation of first progression.
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Anaplastic oligodendroglioma
* Anaplastic oligoastrocytoma
* Anaplastic astrocytoma
* Newly diagnosed disease
* Prior surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
* Absence of combined 1p/19q loss
* Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA methyltransferase promoter methylation status assessment, isocitrate dehydrogenase mutation analysis, and central pathology review
* Patients must be on a stable or decreasing dose of steroids for at least two weeks prior to randomization
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Absolute Neutrophil Count (ANC) = 1.5 x 10^9 cells/L
* Platelet count = 100 x 10^9 cells/L
* Bilirubin < 1.5 x upper limit of normal (ULN)
* Alkaline phosphatase < 2.5 x ULN
* Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5 x ULN
* Serum creatinine < 1.5 x ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No known HIV infection or chronic hepatitis B or hepatitis C infection
* No other serious medical condition that would interfere with follow-up
* No medical condition that could interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction)
* No other prior malignancies except for any malignancy which was treated with curative intent more than 5 years prior to registration and adequately controlled limited basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
* No prior or concurrent malignancies at other sites except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
* No psychological, familial, sociological, or geographical condition that would potentially hamper compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy, including carmustine-containing wafers (Gliadel®)
* No prior radiotherapy to the brain
* No concurrent growth factors unless vital for the patient
* No other concurrent investigational treatment
* No other concurrent anticancer agents
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Minimum age
18
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Maximum age
120
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
751
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal North Shore Hospital - St. Leonards
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Royal Prince Alfred Hospital - Sydney
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Princess Alexandra Hospital - Brisbane
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Royal Melbourne Hospital - Parkville
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Flinders Medical Centre - Bedford Park
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Austin-Repatriation Medical Centre - Heidelberg
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Royal Hobart Hospital - Hobart
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St Vincent'S Hospital - Melbourne
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Sir Charles Gairdner Hospital - Nedlands
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Alfred Hospital - Prahran
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2065 - St. Leonards
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2050 - Sydney
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4102 - Brisbane
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3050 - Parkville
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- Bedford Park
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- Heidelberg
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- Hobart
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- Melbourne
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- Nedlands
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- Prahran
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Recruitment outside Australia
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Sutton
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Wirral
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Funding & Sponsors
Primary sponsor type
Other
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Name
European Organisation for Research and Treatment of Cancer - EORTC
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Other
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NCIC Clinical Trials Group
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Other
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Radiation Therapy Oncology Group
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Medical Research Council
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Commercial sector/industry
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Name [4]
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Merck Sharp & Dohme LLC
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma. PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.
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Trial website
https://clinicaltrials.gov/study/NCT00626990
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Trial related presentations / publications
Tesileanu CMS, Sanson M, Wick W, Brandes AA, Clement PM, Erridge SC, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Rogers L, Taal W, Ruda R, Weller M, McBain C, van Linde ME, Aldape K, Jenkins RB, Kros JM, Wesseling P, von Deimling A, Hoogstrate Y, de Heer I, Atmodimedjo PN, Dubbink HJ, Brouwer RWW, van IJcken WFJ, Cheung KJ, Golfinopoulos V, Baumert BG, Gorlia T, French PJ, van den Bent MJ. Temozolomide and Radiotherapy versus Radiotherapy Alone in Patients with Glioblastoma, IDH-wildtype: Post Hoc Analysis of the EORTC Randomized Phase III CATNON Trial. Clin Cancer Res. 2022 Jun 13;28(12):2527-2535. doi: 10.1158/1078-0432.CCR-21-4283. van den Bent MJ, Tesileanu CMS, Wick W, Sanson M, Brandes AA, Clement PM, Erridge S, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Rogers L, Taal W, Ruda R, Weller M, McBain C, Reijneveld J, Enting RH, Caparrotti F, Lesimple T, Clenton S, Gijtenbeek A, Lim E, Herrlinger U, Hau P, Dhermain F, de Heer I, Aldape K, Jenkins RB, Dubbink HJ, Kros JM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, French P, Baumert BG. Adjuvant and concurrent temozolomide for 1p/19q non-co-deleted anaplastic glioma (CATNON; EORTC study 26053-22054): second interim analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2021 Jun;22(6):813-823. doi: 10.1016/S1470-2045(21)00090-5. Epub 2021 May 14. van den Bent MJ, Baumert B, Erridge SC, Vogelbaum MA, Nowak AK, Sanson M, Brandes AA, Clement PM, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Brachman DG, Taal W, Ruda R, Weller M, McBain C, Reijneveld J, Enting RH, Weber DC, Lesimple T, Clenton S, Gijtenbeek A, Pascoe S, Herrlinger U, Hau P, Dhermain F, van Heuvel I, Stupp R, Aldape K, Jenkins RB, Dubbink HJ, Dinjens WNM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, Wick W, Kros JM. Interim results from the CATNON trial (EORTC study 26053-22054) of treatment with concurrent and adjuvant temozolomide for 1p/19q non-co-deleted anaplastic glioma: a phase 3, randomised, open-label intergroup study. Lancet. 2017 Oct 7;390(10103):1645-1653. doi: 10.1016/S0140-6736(17)31442-3. Epub 2017 Aug 8. Erratum In: Lancet. 2017 Oct 7;390(10103):1644. doi: 10.1016/S0140-6736(17)32438-8.
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Public notes
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Contacts
Principal investigator
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Wolfgang Wick
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Address
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Universitatsklinikum Heidelberg
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/90/NCT00626990/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/90/NCT00626990/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00626990
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