None listed
Conditions
Interventions
Group A Type of group
Cisplatin, in a dose of 80 mg / m on day 1, in an infusion through the intravenous route for 1-2 hours, repeating every three weeks.
Group name:Group B Type of group
Tomudex, at a dose of 3.0 mg / m per day, in infusions by the intravenous route for 15 minutes, followed by Cisplatin in a dose of 80 mg / m on day 1, in an intravenous infusion throughout 1-2 hours, repeating every three weeks.
Sponsors
ASTRAZENECA - PERU,
Eligibility
Inclusion criteria
Inclusion criteria: • A diagnosis of malignant mesothelioma in the histologically proven pleura. An independent review of the pathology sheets will be carried out in all patients. • All tumor extensions are eligible for the present study; and will be classified according to the IMLG-TNM atlas (Appendix I), except for the radically resectable disease, evaluated by the local surgeon. • Prior pleurodesis is allowed, except with cytotoxic drugs (eg, bleomycin), to control spills. • Palliative radiotherapy is allowed for painful lesions or to prevent the development of metastases along biopsy tracings. • The performance condition according to the ZUBROD-ECOG WHO scale • (WHO, World Health Organization) is 6.2 mmol / L is equal to 10.0 g / dL o Leukocyte count> 4.0 x 10 9 / L equals 4000 / mm 3 Absolute neutrophil count> 2.0 x 10 9 / L equals 2000 / mm 3 o Platelets> 100 x 10 9 / L equals 1000 / mm 3 o Bilirubin 3.0 g / dL o Creatinine 65 mL / minute, measured or calculated according to the Cockroft-Gault formula o Alanine aminotransferase (ALAT) and aspartate transaminase (ASAT) 18 years • No symptoms or signs of metastasis in the central nervous system. However, it is not mandatory to take a computerized tomography of the brain or a nuclear magnetic resonance in the absence of neurological signs or symptoms. • Prior to randomization, written authorization to participate in the study must be obtained after learning about the objectives of the study, which must be documented in accordance with local and national regulatory requirements, as well as local rules followed at the institution.
Exclusion criteria
Exclusion criteria: • Previous surgery if there is no evidence of later progression of the disease. • Previous systemic or intracavitary therapy with cytotoxic drugs. • Prior radiation therapy, if given only to the single target lesion, unless the lesion is clearly progressive and the interval between the randomization and the last radiation therapy is at least 4 weeks. • Other malignancies (previous or current), except for an adequately treated carcinoma in situ in the uterine cervix or a carcinoma of the basal cells or squamous cells in the skin, or if the previous malignancy had more than 5 years of evolution and if not there are signs or symptoms of recurrence (except malignant melanoma, hypemefroma and breast carcinoma). • Being pregnant and / or breastfeeding. For fertile patients, adequate contraception should be used. • Be using an agent in research in the month prior to the recruitment in the study. • Present uncontrolled infirmities. • Presence of any psychological, family, sociological or geographical condition that potentially affects compliance with the study protocol and the follow-up program; Such conditions must be evaluated in the patient before their randomization in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Physical examination and evaluation of clinical symptoms Measure:Global survival Timepoints:14 days before starting the treatment, at the end of each cycle, 3 weeks, At the end of the last cycle (3 weeks after the last dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Common Toxicity Criteria, Clinical symptoms / evaluation of toxicity Measure:Toxicity Timepoints:14 days before starting the treatment, at the end of each cycle, 3 weeks, At the end of the last cycle (3 weeks after the last dose) ; Outcome name:Physical examination and evaluation of clinical symptoms, Evaluation of survival Measure:Progression free survival Timepoints:After the PD, 6 weeks ; Outcome name:Questionnaires QLQ-30 and LC13 Measure:Quality of life Timepoints:14 days before starting the treatment, at the end of each cycle, 3 weeks, At the end of the last cycle (3 weeks after the last dose); After the PD, 6 weeks | — |
Outcome results
None listed