Contact information
Type
Scientific
Primary contact
Dr Vanessa Fabricio
ORCID ID
Contact details
Rua Mere Amedea 833
Sao Paulo
02125-001
Brazil
vcf35@terra.com.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Low cost, outpatient, cisplatinum, 5-fluoururacil and leucovorin chemotherapy regimen for advanced head and neck, and upper oesophageal carcinomas
Acronym
Study hypothesis
Evaluate the combination of bolus CDDP cisplatinum, 5-fluoururacil and leucovorin (CFL) in patients with advanced (residual, metastatic or recurrent) squamous cell carcinoma (SCC) of head (H)/neck (N) and oesophagus (E), aiming at a feasible and low cost chemotherapy (CHT) regimen to circumvent the need of infusion pumps and/or hospital admission.
Ethics approval
Ethics approval received from the ABC Medical School Ethics Committee in December 2004 (ref: 185/2004).
Study design
Phase II, single arm study conducted at a single Brazilian Institution
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Head and Neck and Upper oesophageal carcinoma
Intervention
Chemotherapy as follows:
Leucovorin 20 mg/m^2/day bolus infusion for four days (D1 - D4), followed by 5-fluoururacil 370 mg/m^2/day bolus infusion for four days (D1 - D4), and Cisplatinum 25 mg/m^2/day in 90 minutes infusion for three days (D1 - D3), every 21 to 28 days, depending upon hematological recovery.
Follow up is until patient death, expected to be less then 24 months for each patient.
Intervention type
Drug
Phase
Phase II
Drug names
CDDP cisplatinum, 5-fluoururacil and leucovorin (CFL)
Primary outcome measure
1. Quality of life (QoL) evaluated using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) questionnaire, previously used in Portuguese, at the beginning of study and before each cycle
2. Toxicities analysed according to National Cancer Institute (NCI) criteria before each cycle together with KPS, clinical reassessment and laboratory evaluation
3. Response, evaluated by computed tomography (CT) scans after 3rd and 6th cycles of chemotherapy and analysed by response evaluation criteria in solid tumours (RECIST)
4. Performance status by measured with Karnofsky Performance Status (KPS)
Secondary outcome measures
1. Overall survival - time between enrolment and death
2. Progression Free Survival - time between enrolment and disease progression
Overall trial start date
01/01/2005
Overall trial end date
01/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Advanced or recurrent, histologically confirmed, head and neck and oesophagus squamous cell carcinoma
2. Patients have to be 18 years of age or older, either sex
3. Normal renal function
4. Measurable disease by the response evaluation criteria in solid tumours (RECIST)
5. Karnofsky performance status (KPS) equal or greater to 50%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15 patients
Participant exclusion criteria
1. Not meeting the inclusion criteria
2. Concomitant radiation therapy
3. Not a candidate for chemotherapy
Recruitment start date
01/01/2005
Recruitment end date
01/02/2008
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua Mere Amedea 833
Sao Paulo
02125-001
Brazil
Sponsor information
Organisation
Hospital Mario Covas (Brazil)
Sponsor details
Rua Henrique Calderazzo
321
Bairro Paraíso
Santo Andre
09190-615
Brazil
sau@hesa-fuabc.org.br
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
ABC Foundation (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Hospital Mario Covas (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list