Condition category
Cancer
Date applied
18/01/2008
Date assigned
26/02/2008
Last edited
26/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.hospitalmariocovas.org.br

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes