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 |
| Protocol serial number | N/A |
| Sponsor | Hospital Mario Covas (Brazil) |
| Funders | ABC Foundation (Brazil), Hospital Mario Covas (Brazil) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Rua Mere Amedea 833
Sao Paulo
02125-001
Brazil
| vcf35@terra.com.br |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase II, single arm study conducted at a single Brazilian Institution |
| Secondary study design | Non randomised controlled trial |
| 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | CDDP cisplatinum, 5-fluoururacil and leucovorin (CFL) |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Overall survival - time between enrolment and death |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 15 |
| 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
02125-001
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
