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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00154102




Registration number
NCT00154102
Ethics application status
Date submitted
8/09/2005
Date registered
12/09/2005
Date last updated
30/01/2017

Titles & IDs
Public title
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
Scientific title
Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer
Secondary ID [1] 0 0
EMR 62202-013
Universal Trial Number (UTN)
Trial acronym
CRYSTAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cetuximab
Treatment: Drugs - FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)

Experimental: Cetuximab Plus FOLFIRI -

Active Comparator: FOLFIRI Alone -


Treatment: Drugs: Cetuximab
Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Number of Cycles: until progression or unacceptable toxicity develops

Treatment: Drugs: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops

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

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments - Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Timepoint [1] 0 0
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Primary outcome [2] 0 0
Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments - Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Timepoint [2] 0 0
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Primary outcome [3] 0 0
Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments - Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Timepoint [3] 0 0
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Secondary outcome [1] 0 0
Overall Survival Time (OS) - Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.
Timepoint [1] 0 0
Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009
Secondary outcome [2] 0 0
Overall Survival Time (KRAS Wild-Type Population) - Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.
Timepoint [2] 0 0
Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009
Secondary outcome [3] 0 0
Overall Survival Time (KRAS Mutant Population) - Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.
Timepoint [3] 0 0
Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009
Secondary outcome [4] 0 0
Best Overall Response Rate - Independent Review Committee (IRC) Assessments - The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
Timepoint [4] 0 0
evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Secondary outcome [5] 0 0
Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments - The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
Timepoint [5] 0 0
evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Secondary outcome [6] 0 0
Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments - The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
Timepoint [6] 0 0
evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Secondary outcome [7] 0 0
Disease Control Rate - Independent Review Committee (IRC) Assessments - The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).
Timepoint [7] 0 0
Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Secondary outcome [8] 0 0
Duration of Response - Independent Review Committee (IRC) Assessments - Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).
Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.
Timepoint [8] 0 0
Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Secondary outcome [9] 0 0
Participants With No Residual Tumor After Metastatic Surgery - Participants with no residual tumor after on-study surgery for metastases
Timepoint [9] 0 0
time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007
Secondary outcome [10] 0 0
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status - Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
Timepoint [10] 0 0
at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Secondary outcome [11] 0 0
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning - Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.
Timepoint [11] 0 0
at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Secondary outcome [12] 0 0
Safety - Number of Patients Experiencing Any Adverse Event - Please refer to Adverse Events section for further details
Timepoint [12] 0 0
time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007

Eligibility
Key inclusion criteria
- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum

- Inoperable metastatic disease

- Immunohistochemical evidence of epidermal growth factor receptor expression in tumor
tissue

- Presence of at least 1 bi-dimensionally measurable index lesion
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous irinotecan-based chemotherapy

- Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated
more than 6 months before the start of study treatment

- Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug
in the 30 days before the start of study treatment

- Brain metastasis

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
Open (masking not used)
Who is / are masked / blinded?



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)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Darlinghurst
Recruitment hospital [3] 0 0
Research Site - Heidelberg
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - West Perth
Recruitment hospital [6] 0 0
Research Site - Woodville
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment postcode(s) [5] 0 0
- West Perth
Recruitment postcode(s) [6] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Klagenfurt
Country [4] 0 0
Austria
State/province [4] 0 0
Kufstein
Country [5] 0 0
Austria
State/province [5] 0 0
Salzburg
Country [6] 0 0
Austria
State/province [6] 0 0
St. Pölten
Country [7] 0 0
Austria
State/province [7] 0 0
St. Veit an der Glan
Country [8] 0 0
Austria
State/province [8] 0 0
Wels
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerpen
Country [11] 0 0
Belgium
State/province [11] 0 0
Bonheiden
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Edegem
Country [14] 0 0
Belgium
State/province [14] 0 0
Gent
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Belgium
State/province [16] 0 0
Liège
Country [17] 0 0
Brazil
State/province [17] 0 0
Goiania
Country [18] 0 0
Brazil
State/province [18] 0 0
Porto Alegre
Country [19] 0 0
Brazil
State/province [19] 0 0
Santo André
Country [20] 0 0
Brazil
State/province [20] 0 0
Sao Paulo
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Pleven
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Plovidiv
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sofia
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Varna
Country [25] 0 0
Chile
State/province [25] 0 0
Santiago-Las Condes
Country [26] 0 0
Chile
State/province [26] 0 0
Santiago-Providencia
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Chomutov
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Prague
Country [29] 0 0
Finland
State/province [29] 0 0
Turku
Country [30] 0 0
France
State/province [30] 0 0
Bordeaux
Country [31] 0 0
France
State/province [31] 0 0
Boulogne-Billancourt
Country [32] 0 0
France
State/province [32] 0 0
Colmar
Country [33] 0 0
France
State/province [33] 0 0
Grenoble
Country [34] 0 0
France
State/province [34] 0 0
La Roche sur Yon
Country [35] 0 0
France
State/province [35] 0 0
Lorient
Country [36] 0 0
France
State/province [36] 0 0
Marseille
Country [37] 0 0
France
State/province [37] 0 0
Nantes
Country [38] 0 0
France
State/province [38] 0 0
Perigueux
Country [39] 0 0
France
State/province [39] 0 0
Rennes Cedex
Country [40] 0 0
France
State/province [40] 0 0
Saint Gregoire
Country [41] 0 0
France
State/province [41] 0 0
Strasbourg
Country [42] 0 0
France
State/province [42] 0 0
Toulon
Country [43] 0 0
France
State/province [43] 0 0
Villejuif Cedex
Country [44] 0 0
Germany
State/province [44] 0 0
Dortmund
Country [45] 0 0
Germany
State/province [45] 0 0
Dresden
Country [46] 0 0
Germany
State/province [46] 0 0
Düsseldorf
Country [47] 0 0
Germany
State/province [47] 0 0
Essen
Country [48] 0 0
Germany
State/province [48] 0 0
Frankfurt am Main
Country [49] 0 0
Germany
State/province [49] 0 0
Freiburg
Country [50] 0 0
Germany
State/province [50] 0 0
Göttingen
Country [51] 0 0
Germany
State/province [51] 0 0
Halle
Country [52] 0 0
Germany
State/province [52] 0 0
Hamburg
Country [53] 0 0
Germany
State/province [53] 0 0
Heidelberg
Country [54] 0 0
Germany
State/province [54] 0 0
Homburg/Saar
Country [55] 0 0
Germany
State/province [55] 0 0
Jena
Country [56] 0 0
Germany
State/province [56] 0 0
Mainz
Country [57] 0 0
Germany
State/province [57] 0 0
Mannheim
Country [58] 0 0
Germany
State/province [58] 0 0
München
Country [59] 0 0
Germany
State/province [59] 0 0
Oldenburg
Country [60] 0 0
Germany
State/province [60] 0 0
Ulm
Country [61] 0 0
Greece
State/province [61] 0 0
Alexandroupolis
Country [62] 0 0
Greece
State/province [62] 0 0
Athens
Country [63] 0 0
Greece
State/province [63] 0 0
Heraklion
Country [64] 0 0
Hong Kong
State/province [64] 0 0
Pokfulam
Country [65] 0 0
Hong Kong
State/province [65] 0 0
Shatin
Country [66] 0 0
Hungary
State/province [66] 0 0
Budapest
Country [67] 0 0
Hungary
State/province [67] 0 0
Debrecen
Country [68] 0 0
Hungary
State/province [68] 0 0
Györ
Country [69] 0 0
Hungary
State/province [69] 0 0
Kecskemét
Country [70] 0 0
Hungary
State/province [70] 0 0
Pécs
Country [71] 0 0
Italy
State/province [71] 0 0
Ancona
Country [72] 0 0
Italy
State/province [72] 0 0
Aviano
Country [73] 0 0
Italy
State/province [73] 0 0
Bari
Country [74] 0 0
Italy
State/province [74] 0 0
Benevento
Country [75] 0 0
Italy
State/province [75] 0 0
Firenze
Country [76] 0 0
Italy
State/province [76] 0 0
Mantova
Country [77] 0 0
Italy
State/province [77] 0 0
Milano
Country [78] 0 0
Italy
State/province [78] 0 0
Modena
Country [79] 0 0
Italy
State/province [79] 0 0
Napoli
Country [80] 0 0
Italy
State/province [80] 0 0
Reggio Emilia
Country [81] 0 0
Italy
State/province [81] 0 0
Roma
Country [82] 0 0
Italy
State/province [82] 0 0
Rozzano
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Seoul
Country [84] 0 0
Mexico
State/province [84] 0 0
Mexico
Country [85] 0 0
Netherlands
State/province [85] 0 0
Amsterdam
Country [86] 0 0
Netherlands
State/province [86] 0 0
Apeldoom
Country [87] 0 0
Netherlands
State/province [87] 0 0
Blaricum
Country [88] 0 0
Netherlands
State/province [88] 0 0
Den Haag
Country [89] 0 0
Netherlands
State/province [89] 0 0
Roosendaal
Country [90] 0 0
Netherlands
State/province [90] 0 0
Zwolle
Country [91] 0 0
Poland
State/province [91] 0 0
Bialystok
Country [92] 0 0
Poland
State/province [92] 0 0
Gliwice
Country [93] 0 0
Poland
State/province [93] 0 0
Krakow
Country [94] 0 0
Poland
State/province [94] 0 0
Opole
Country [95] 0 0
Poland
State/province [95] 0 0
Poznan
Country [96] 0 0
Poland
State/province [96] 0 0
Warsaw
Country [97] 0 0
Poland
State/province [97] 0 0
Wroclaw
Country [98] 0 0
Romania
State/province [98] 0 0
Cluj Napoca
Country [99] 0 0
Romania
State/province [99] 0 0
Iasi
Country [100] 0 0
Romania
State/province [100] 0 0
Suceava
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Moscow
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Saint Petersburg
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Yaroslavl
Country [104] 0 0
Singapore
State/province [104] 0 0
Singapore
Country [105] 0 0
Slovakia
State/province [105] 0 0
Banska Bystrica
Country [106] 0 0
Slovakia
State/province [106] 0 0
Bratislava
Country [107] 0 0
Slovakia
State/province [107] 0 0
Kosice
Country [108] 0 0
Slovakia
State/province [108] 0 0
Trnava
Country [109] 0 0
Slovakia
State/province [109] 0 0
Zilina
Country [110] 0 0
South Africa
State/province [110] 0 0
Cape Town
Country [111] 0 0
South Africa
State/province [111] 0 0
Durban
Country [112] 0 0
South Africa
State/province [112] 0 0
Johannesburg
Country [113] 0 0
South Africa
State/province [113] 0 0
Port Elizabeth
Country [114] 0 0
South Africa
State/province [114] 0 0
Pretoria
Country [115] 0 0
Spain
State/province [115] 0 0
A Coruna
Country [116] 0 0
Spain
State/province [116] 0 0
Barcelona
Country [117] 0 0
Spain
State/province [117] 0 0
Cadiz
Country [118] 0 0
Spain
State/province [118] 0 0
Madrid
Country [119] 0 0
Spain
State/province [119] 0 0
Palma de Mallorca
Country [120] 0 0
Spain
State/province [120] 0 0
Valencia
Country [121] 0 0
Sweden
State/province [121] 0 0
Göteborg
Country [122] 0 0
Sweden
State/province [122] 0 0
Stockholm
Country [123] 0 0
Taiwan
State/province [123] 0 0
Changhua
Country [124] 0 0
Taiwan
State/province [124] 0 0
Chiayi
Country [125] 0 0
Taiwan
State/province [125] 0 0
Taipei
Country [126] 0 0
Taiwan
State/province [126] 0 0
Taoyuan
Country [127] 0 0
Turkey
State/province [127] 0 0
Ankara
Country [128] 0 0
Turkey
State/province [128] 0 0
Istanbul
Country [129] 0 0
Turkey
State/province [129] 0 0
Izmir
Country [130] 0 0
Ukraine
State/province [130] 0 0
Charkassy
Country [131] 0 0
Ukraine
State/province [131] 0 0
Donetsk
Country [132] 0 0
Ukraine
State/province [132] 0 0
Ivano-Frankivsk
Country [133] 0 0
Ukraine
State/province [133] 0 0
Kiev
Country [134] 0 0
Ukraine
State/province [134] 0 0
Krivoy Rog
Country [135] 0 0
Ukraine
State/province [135] 0 0
Lugansk
Country [136] 0 0
Ukraine
State/province [136] 0 0
Lviv
Country [137] 0 0
Ukraine
State/province [137] 0 0
Uzhgorod
Country [138] 0 0
Ukraine
State/province [138] 0 0
Zhaporozhye
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Brighton
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Cambridge
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Glasgow
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Guildford
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Kent
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Leicester
Country [145] 0 0
United Kingdom
State/province [145] 0 0
London
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Peterborough
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Rhyl
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck KGaA, Darmstadt, Germany
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Drugs used against cancer work in different ways to stop the growth of tumor cells, either by
killing the cells or by stopping them from dividing. Monoclonal antibodies, such as
cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together
with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer
('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known
whether giving combination chemotherapy together with cetuximab is more effective than
combination chemotherapy alone. This open-label trial investigates the effectiveness of
cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil
(5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line
setting, compared to the same chemotherapy alone on patient expressing the epidermal growth
factor (EGF) receptor.

Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to
either receive the combination chemotherapy alone or with cetuximab (open-label study) and
will then be treated until progression of the disease or unacceptable toxicity occur. Regular
efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study
together with regular safety assessments (e.g. safety labs). An independent Safety Board of
experts will also monitor safety data.

After participant discontinuation from the trial, regular updates on further treatments and
survival status will be requested from the investigator.

The entire study (from the first patient entering the study to the last collect of follow-up
information) is 4-5 years long.
Trial website
https://clinicaltrials.gov/show/NCT00154102
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eric van Cutsem, Professor
Address 0 0
University Hospital Gasthuisberg, Department Internal Medicine, Leuven, Belgium
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