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

Low cost, outpatient, cisplatinum, 5-fluoururacil and leucovorin chemotherapy regimen for advanced head and neck, and upper oesophageal carcinomas

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN09659857

Enrollment

Registered

2008-02-26

Start date

2005-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck and Upper oesophageal carcinoma Cancer Squamous cell carcinoma

Interventions

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/d

Eligibility

Sex/Gender

All

Inclusion criteria

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%

Exclusion criteria

Exclusion criteria: 1. Not meeting the inclusion criteria 2. Concomitant radiation therapy 3. Not a candidate for chemotherapy

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
1. Overall survival - time between enrolment and death 2. Progression Free Survival - time between enrolment and disease progression	—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026