Patients with advanced cancer.
Conditions
Interventions
Trade Name: Cisplatino FERRER FARMA
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CISPLATIN
CAS Number: 15663-27-1
Current Sponsor code: Cisplatin Acoord
Concentratio
Sponsors
Institut de Recerca HSCSP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women ? 18 years of age. 2. Patients potentially eligible to receive a new chemotherapy treatment and whose clinical condition, according to the oncologist responsible, does not identify any therapeutic strategy clearly superior to another, in the light of available scientific evidence. 3. Patients with advanced cancers that have been treated with chemotherapy but have not submitted a complete response to treatment or who, having presented, are now in a situation of recurrence or disease progression 5. Patients who have previously completed a number of chemotherapies. Depending on the type of cancer will be considered: ? Cancers of the digestive and gastrointestinal ? Head and Neck Cancers ? Cancer Bronchopulmonary ? Urological Cancer ? Gynecologic Cancer ? Central Nervous System Cancer ? Melanoma 6. Patients with potential capacity to complete the study, and accept and sign the informed consent. 7. Patients whose home is located less than 10 km from the hospitals participating in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: 1. Patients who are in course of any chemotherapy. Not be considered an exclusion criterion that the patient is enrolled in any other concomitant therapy (e.g., hormone or radiation therapy). 2. Patients with contraindications to chemotherapy. 3. Patients who refuse to enter into the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and cost-effectiveness of a comprehensive care program (PAI) combined with chemotherapy versus those obtained in patients treated without chemotherapy in the PAI in patients with advanced cancer.;Secondary Objective: 1. To compare survival in patients treated with PAI versus that obtained in patients treated with palliative chemotherapy plus standard PAI. 2. To compare the control of symptoms, quality of life, level of satisfaction in patients treated with PAI versus that obtained in patients treated with palliative chemotherapy plus standard PAI. 3. To compare the toxicity in patients treated with PAI versus that obtained in patients treated with palliative chemotherapy plus standard PAI. 4. To compare the costs and cost-effectiveness in patients with advanced cancer treated with PAI versus that obtained in patients treated with palliative chemotherapy plus standard PAI.;Primary end point(s): Survival adjusted per quality of live al año.;Timepoint(s) of evaluation of this end point: One year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Survival: number of days of life of patients from inclusion in the study. 2) Quality of life 3) Control of symptoms 4) Toxicity 5) Patient satisfaction regarding the care provided 6) Costs;Timepoint(s) of evaluation of this end point: 1) Survival: during the firsts year. 2) Quality of life will be measured biweekly during the first month and then monthly. 3) Control of symptoms: Every two weeks during the first month and then monthly. 4) Toxicity: Monthly. 5) Patient satisfaction regarding the care provided: Monthly t 6) Costs: at the end of study. | — |
Countries
Spain
Contacts
Public ContactRomy Rodriguez
Institut de Recerca HSCSP
Outcome results
None listed