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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00901901




Registration number
NCT00901901
Ethics application status
Date submitted
13/05/2009
Date registered
13/05/2009
Date last updated
7/06/2018

Titles & IDs
Public title
Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma
Scientific title
A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
Secondary ID [1] 0 0
2008-006021-14
Secondary ID [2] 0 0
12917
Universal Trial Number (UTN)
Trial acronym
SEARCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular 0 0
Carcinoma, Hepatocellular 0 0
Carcinoma, Hepatocellular 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sorafenib (Nexavar, BAY43-9006)
Treatment: Drugs - Erlotinib (Tarceva)
Treatment: Drugs - Placebo
Treatment: Drugs - Sorafenib (Nexavar, BAY43-9006)
Treatment: Drugs - Erlotinib (Tarceva)
Treatment: Drugs - Placebo
Treatment: Drugs - Sorafenib (Nexavar, BAY43-9006)
Treatment: Drugs - Erlotinib (Tarceva)
Treatment: Drugs - Placebo

Experimental: Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) - Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)

Active Comparator: Sorafenib (Nexavar, BAY43-9006) + Placebo - Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)

Experimental: Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) - Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)

Active Comparator: Sorafenib (Nexavar, BAY43-9006) + Placebo - Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)

Experimental: Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva) - Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)

Active Comparator: Sorafenib (Nexavar, BAY43-9006) + Placebo - Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)


Treatment: Drugs: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg twice daily

Treatment: Drugs: Erlotinib (Tarceva)
Erlotinib 150 mg once daily

Treatment: Drugs: Placebo
Matching erlotinib placebo 150 mg once daily

Treatment: Drugs: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg twice daily

Treatment: Drugs: Erlotinib (Tarceva)
Erlotinib 150 mg once daily

Treatment: Drugs: Placebo
Matching erlotinib placebo 150 mg once daily

Treatment: Drugs: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg twice daily

Treatment: Drugs: Erlotinib (Tarceva)
Erlotinib 150 mg once daily

Treatment: Drugs: Placebo
Matching erlotinib placebo 150 mg once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival - Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.
Timepoint [1] 0 0
From randomization of the first patient until 34 months or date of death of any cause whichever came first
Primary outcome [2] 0 0
Overall Survival - Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.
Timepoint [2] 0 0
From randomization of the first patient until 34 months or date of death of any cause whichever came first
Primary outcome [3] 0 0
Overall Survival - Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.
Timepoint [3] 0 0
From randomization of the first patient until 34 months or date of death of any cause whichever came first
Secondary outcome [1] 0 0
Time to Radiological Tumor Progression (TTP) - TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD.
Timepoint [1] 0 0
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Secondary outcome [2] 0 0
Disease Control - Disease control was defined as the number of participants who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD.
Timepoint [2] 0 0
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Secondary outcome [3] 0 0
Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index - The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems'). The 5 health dimensions are summarized into a single score, the EQ-5D index score. The EQ-5D index score has a range of 0 and 1 with 0 representing death and 1 representing perfect health.
Timepoint [3] 0 0
The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.
Secondary outcome [4] 0 0
Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS - Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.
Timepoint [4] 0 0
The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.
Secondary outcome [5] 0 0
Time to Radiological Tumor Progression (TTP) - TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD.
Timepoint [5] 0 0
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Secondary outcome [6] 0 0
Disease Control - Disease control was defined as the number of participants who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD.
Timepoint [6] 0 0
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Secondary outcome [7] 0 0
Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index - The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems'). The 5 health dimensions are summarized into a single score, the EQ-5D index score. The EQ-5D index score has a range of 0 and 1 with 0 representing death and 1 representing perfect health.
Timepoint [7] 0 0
The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.
Secondary outcome [8] 0 0
Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS - Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.
Timepoint [8] 0 0
The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.
Secondary outcome [9] 0 0
Time to Radiological Tumor Progression (TTP) - TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD.
Timepoint [9] 0 0
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Secondary outcome [10] 0 0
Disease Control - Disease control was defined as the number of participants who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD.
Timepoint [10] 0 0
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Secondary outcome [11] 0 0
Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index - The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems'). The 5 health dimensions are summarized into a single score, the EQ-5D index score. The EQ-5D index score has a range of 0 and 1 with 0 representing death and 1 representing perfect health.
Timepoint [11] 0 0
The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.
Secondary outcome [12] 0 0
Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS - Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.
Timepoint [12] 0 0
The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.

Eligibility
Key inclusion criteria
- Patients > 18 years of age

- Patients who have a life expectancy of at least 12 weeks

- Patients with histological or cytologically documented HCC

- Patients must have at least one tumor lesion that meets both of the following
criteria:

- The lesion can be accurately measured in at least one dimension according to
response evaluation criteria in solid tumors (RECIST)

- The lesion has not been previously treated with local therapy

- Patients who have an ECOG PS (Eastern Cooperative Oncology Group Performance Status)
of 0 or 1

- Cirrhotic status of Child-Pugh class A.

- Patients who give written informed consent prior to any study specific screening
procedures with the understanding that the patient has the right to withdraw from the
study at any time.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of cardiac disease: congestive heart failure > New York Heart Association
(NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring
anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled
hypertension. Myocardial infarction more than 6 months prior to study entry is
permitted.

- Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sogren's
syndrome) including congenital abnormality (e.g. Fuch's dystrophy), abnormal slit-lamp
examination using a vital dye (e.g. fluorescein, Bengal-Rose), and/or an abnormal
corneal sensitivity test (Schirmer test or similar tear production test).

- History of interstitial lung disease (ILD).

- Patients with clinically significant gastrointestinal bleeding within 30 days prior to
study entry.

- Previous treatment with yttrium-90 spheres

- Any condition that is unstable or which could jeopardize the safety of the patient and
his/her compliance in the study.

- Uncontrolled ascites (defined as not easily controlled with diuretic treatment)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- Randwick
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Herston
Recruitment hospital [4] 0 0
- Clayton
Recruitment hospital [5] 0 0
- Melbourne
Recruitment hospital [6] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4120 - Brisbane
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Austria
State/province [19] 0 0
Wien
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles - Brussel
Country [21] 0 0
Belgium
State/province [21] 0 0
Edegem
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
Country [23] 0 0
Belgium
State/province [23] 0 0
Kortrijk
Country [24] 0 0
Belgium
State/province [24] 0 0
La Louviere
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Belgium
State/province [26] 0 0
Liege
Country [27] 0 0
Brazil
State/province [27] 0 0
Minas Gerais
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio Grande Do Sul
Country [29] 0 0
Brazil
State/province [29] 0 0
Sao Paulo
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio de Janeiro
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Plovdiv
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Varna
Country [34] 0 0
Canada
State/province [34] 0 0
Alberta
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Chile
State/province [36] 0 0
Santiago
Country [37] 0 0
China
State/province [37] 0 0
Guangdong
Country [38] 0 0
China
State/province [38] 0 0
Jiangsu
Country [39] 0 0
China
State/province [39] 0 0
Zhejiang
Country [40] 0 0
China
State/province [40] 0 0
Beijing
Country [41] 0 0
Colombia
State/province [41] 0 0
Floridablanca
Country [42] 0 0
Colombia
State/province [42] 0 0
Medellín
Country [43] 0 0
France
State/province [43] 0 0
Bordeaux
Country [44] 0 0
France
State/province [44] 0 0
Clichy
Country [45] 0 0
France
State/province [45] 0 0
Creteil
Country [46] 0 0
France
State/province [46] 0 0
La Roche Sur Yon
Country [47] 0 0
France
State/province [47] 0 0
Lille
Country [48] 0 0
France
State/province [48] 0 0
Lyon
Country [49] 0 0
France
State/province [49] 0 0
Marseille
Country [50] 0 0
France
State/province [50] 0 0
Paris
Country [51] 0 0
France
State/province [51] 0 0
Pessac
Country [52] 0 0
France
State/province [52] 0 0
Vandoeuvre-les-nancy
Country [53] 0 0
France
State/province [53] 0 0
Villejuif
Country [54] 0 0
Germany
State/province [54] 0 0
Baden-Württemberg
Country [55] 0 0
Germany
State/province [55] 0 0
Bayern
Country [56] 0 0
Germany
State/province [56] 0 0
Hessen
Country [57] 0 0
Germany
State/province [57] 0 0
Niedersachsen
Country [58] 0 0
Germany
State/province [58] 0 0
Nordrhein-Westfalen
Country [59] 0 0
Germany
State/province [59] 0 0
Rheinland-Pfalz
Country [60] 0 0
Germany
State/province [60] 0 0
Saarland
Country [61] 0 0
Germany
State/province [61] 0 0
Berlin
Country [62] 0 0
Greece
State/province [62] 0 0
Athens
Country [63] 0 0
Greece
State/province [63] 0 0
Larissa
Country [64] 0 0
Greece
State/province [64] 0 0
Thessaloniki
Country [65] 0 0
Hong Kong
State/province [65] 0 0
Hong Kong
Country [66] 0 0
Hong Kong
State/province [66] 0 0
Shatin
Country [67] 0 0
Israel
State/province [67] 0 0
Beer Sheva
Country [68] 0 0
Israel
State/province [68] 0 0
Haifa
Country [69] 0 0
Israel
State/province [69] 0 0
Petah Tikva
Country [70] 0 0
Israel
State/province [70] 0 0
Rehovot
Country [71] 0 0
Israel
State/province [71] 0 0
Zrifin
Country [72] 0 0
Italy
State/province [72] 0 0
Lombardia
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Gyeonggido
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Seoul
Country [75] 0 0
New Zealand
State/province [75] 0 0
Auckland
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New Zealand
State/province [76] 0 0
Christchurch
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New Zealand
State/province [77] 0 0
Wellington South
Country [78] 0 0
Peru
State/province [78] 0 0
Lima
Country [79] 0 0
Poland
State/province [79] 0 0
Bydgoszcz
Country [80] 0 0
Poland
State/province [80] 0 0
Gdansk
Country [81] 0 0
Poland
State/province [81] 0 0
Gliwice
Country [82] 0 0
Poland
State/province [82] 0 0
Warszawa
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Barnaul
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Moscow
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Nizhny Novgorod
Country [86] 0 0
Singapore
State/province [86] 0 0
Singapore
Country [87] 0 0
South Africa
State/province [87] 0 0
Gauteng
Country [88] 0 0
South Africa
State/province [88] 0 0
Western Cape
Country [89] 0 0
Spain
State/province [89] 0 0
Barcelona
Country [90] 0 0
Spain
State/province [90] 0 0
Lugo
Country [91] 0 0
Spain
State/province [91] 0 0
Madrid
Country [92] 0 0
Spain
State/province [92] 0 0
Santander
Country [93] 0 0
Spain
State/province [93] 0 0
Valencia
Country [94] 0 0
Taiwan
State/province [94] 0 0
Tainan
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taipei
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taoyuan
Country [97] 0 0
United Kingdom
State/province [97] 0 0
South Yorkshire
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Glasgow
Country [99] 0 0
United Kingdom
State/province [99] 0 0
London
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily
and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib
once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients
who are candidates for potentially curative intervention (i.e. surgical resection or local
ablation) are not eligible for this study.
Trial website
https://clinicaltrials.gov/show/NCT00901901
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications