Outpatient chemotherapy protocol using 3 cosolidated drugs (cisplatin, 5 fluoururacil and leucovorin) in a different scheme for the treatment of head and neck and oesophageal cancer, designed for patients without surgical and radiation therapy options

ISRCTN	ISRCTN09659857
DOI	https://doi.org/10.1186/ISRCTN09659857
Secondary identifying numbers	N/A

Submission date: 18/01/2008
Registration date: 26/02/2008
Last edited: 26/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Vanessa Fabricio
Scientific

Rua Mere Amedea 833
Sao Paulo
02125-001
Brazil

Email	vcf35@terra.com.br

Study information

Study design	Phase II, single arm study conducted at a single Brazilian Institution
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Low cost, outpatient, cisplatinum, 5-fluoururacil and leucovorin chemotherapy regimen for advanced head and neck, and upper oesophageal carcinomas
Study objectives	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(s)	Ethics approval received from the ABC Medical School Ethics Committee in December 2004 (ref: 185/2004).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	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 study start date	01/01/2005
Completion date	01/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	15 patients
Key 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%
Key exclusion criteria	1. Not meeting the inclusion criteria 2. Concomitant radiation therapy 3. Not a candidate for chemotherapy
Date of first enrolment	01/01/2005
Date of final enrolment	01/02/2008

Locations

Countries of recruitment

Brazil

Study participating centre

Rua Mere Amedea 833

Sao Paulo
02125-001
Brazil

Sponsor information

Hospital Mario Covas (Brazil)
Hospital/treatment centre

Rua Henrique Calderazzo, 321
Bairro Paraíso
Santo Andre
09190-615
Brazil

Email	sau@hesa-fuabc.org.br
Website	http://www.hospitalmariocovas.org.br
"ROR"	https://ror.org/00s7ek396

Funders

Funder type

Research organisation

ABC Foundation (Brazil)

No information available

Hospital Mario Covas (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan