Phase II clinical trial with tri-weekly metronomic oral vinorelbine and cisplatin as induction treatment for and subsequent concomitant with radiotherapy (RT) in patients with non small cell lung cancer (NSCLC) locally advanced unresectable.
- Conditions
- nresectable locally advanced non-small cell lung cancer.MedDRA version: 18.1 Level: LLT Classification code 10025053 Term: Lung cancer non-small cell stage IIIA System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-003312-21-ES
- Lead Sponsor
- Grupo Español de Cáncer de Pulmón
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 67
-Patients with confirmed histologic diagnosis of NSCLC?s in stage IIIA and IIIB unresectables.
-Realization of a basal PET-CT that dismisses the presence of distant disease and confirm that it is a NSCLC not candidate to radical surgery treatment. The positive mediastinal lymph nodes for PET-CT have to be confirmed histologically. It could be considered affected mediastinic lymph nodes without necessity of verify histologically, when there is a mass at the lymph nodes area without distinguished edges.
-Disease measurable by CT, as minimum one lesion.
-Performance status ECOG 0-1.
-Life expectation > 12 weeks.
-Age ?18 years and ? 75 years.
-Satisfactory renal function: creatinine ? 1.5 mg/dl or creatinine clearance > 60 ml/min.
-Correct hematological function: Hemoglobin > 10 g/dl, neutrophils ? 1500, platelets ? 100000.
-Correct liver function: bilirubin ? 1.5 times the maximum limit of the normality, transaminases ? 2.5 over the upper limit of the normality.
-Correct lung function: defined by forced expired volume in 1 second (FEV1) >50% of normal volume, and lung diffusing capacity for carbon monoxide (DLCO) > 40% of normal value.
-Lung normal proportion exposed to >20 Gy of RT (V20) have to be ? 35%.
-Informed consent signature
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17
-Decrease in weight > 5% in the last 3 months previous to the study entry.
-Intestinal problems that do not ensure a correct absorption of oral vinorelbine.
-Pregnant and lactating women. Women in childbearing age should have a negative pregnancy test, men and women under this condition should use contraceptive measures during all the clinical trial.
-Symptomatic sensory neuropathy > grade 1 according with the toxicity criteria of CTCAE v4.
-Non-controlled comorbidities.
-Superior vena cava syndrome.
-Pleural or pericardial effusion: both will be considered as metastatic disease indicators unless will be demonstrated the opposite. These that have a negative cytological for malignancy, being exudate, will be excluded too. These patients with non-visible pleural effusion in thoracic radiology or so small for realize a safe diagnostic puncture can be included.
-Known hypersensitivity to drugs with similar structure of the study drugs.
-Previous treatment with antineoplastic drugs or previous thoracic radiotherapy for the lung cancer or for other reason. Previous surgery for the lung cancer.
-Personal background of other neoplasia, except cervical or breast carcinoma in situ and the skin basal cell carcinoma, treated in the correct way in a period of less than 5 years.
-Concomitant treatment with any other antineoplastic medicine or in investigation study.
- Patients in any psychological situation, familiar, sociological or geographical that can complicate the correct accomplishment of the study protocol and the following-up program
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method