Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First/last subject(informed consent): 14Dec 2004/28 Dec2005. Clinical cut-off: 12 Mar 2007. 80 centers in Europe: Austria (3), Belgium (5), Czech Republic (2), France (12),Germany (8), Hungary (4), Italy (5), Netherlands (4), Poland (5), Portugal (3), Russia (4), Slovakia (2), Spain (9), Sweden (3), Switzerland (3), UK (4), and Ukraine (4).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
477 subjects screened. 41 ineligible for treatment at end of screening (inclusion/exclusion criteria not fulfilled (30),death (3),consent withdrawal(3), symptomatic deterioration(2),non-compliance with timelines(1),refusal to continue study procedures (1), missing (1).436 eligible for treatment; however 6 of the ineligible patients were randomized

Reporting Groups

	Description
Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
Chemotherapy Alone	All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.

Participant Flow:   Overall Study

	Cetuximab Plus Chemotherapy	Chemotherapy Alone
STARTED	222 [1]	220 [1]
COMPLETED	215	219
NOT COMPLETED	7	1
investigational study phase ongoing	7	1

Reporting Groups

	Description
Cetuximab Plus Chemotherapy	Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
Chemotherapy Alone	All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.

Baseline Measures

	Cetuximab Plus Chemotherapy	Chemotherapy Alone	Total
Number of Participants   [units: participants]	222	220	442
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	183	182	365
>=65 years	39	38	77
Age   [units: years] Mean ± Standard Deviation	57.1  ± 8.0	56.7  ± 8.7	56.9  ± 8.3
Gender   [units: participants]
Female	25	18	43
Male	197	202	399
Region of Enrollment   [units: participants]
Portugal	3	6	9
Slovakia	3	1	4
Spain	38	41	79
Ukraine	18	16	34
Austria	4	10	14
Russian Federation	9	7	16
United Kingdom	4	5	9
Switzerland	4	4	8
Italy	14	12	26
France	45	31	76
Czech Republic	4	5	9
Hungary	19	24	43
Belgium	14	16	30
Poland	18	18	36
Germany	18	14	32
Netherlands	4	6	10
Sweden	3	4	7

1.  Primary:

Overall Survival Time (OS)   [ Time Frame: time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 ]

2.  Secondary:

Progression-free Survival Time (PFS)   [ Time Frame: time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 ]

3.  Secondary:

Best Overall Response   [ Time Frame: evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 ]

4.  Secondary:

Disease Control   [ Time Frame: evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 ]

5.  Secondary:

Time to Treatment Failure   [ Time Frame: Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007 ]

6.  Secondary:

Duration of Response   [ Time Frame: 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, 21 Dec 2004, until cut-off date 12 Mar 2007 ]

7.  Secondary:

Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status   [ Time Frame: at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007 ]

8.  Secondary:

Quality of Life Assessment (EORTC QLQ-C30) Social Functioning   [ Time Frame: at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007 ]

9.  Secondary:

Safety - Number of Patients Experiencing Any Adverse Event   [ Time Frame: time from first dose up to 30 after last dose of study treatment, reported between day of first dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007 ]