Study of Vinorelbine and Cisplatin as Induction Therapy With Radiotherapy in Patients With Unresectable NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Vinorelbine; Cisplatin; Vinorelbine; Cisplatin; Radiotherapy
Intervention description: Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday); Cycle 1 and 2 day 1, 80 mg/m2; Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday); Cycle 3 and 4 day 1, 80 mg/m2; concomitant therapy during cycles 3 and 4. Total dose: 66Gy
Intervention MeSH terms: Cisplatin; Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Lung Cancer; Cancer Lung Disease; NORA; GECP 15/02; Metronomic administration

Summary:

      Phase II clinical trial with metronomic oral vinorelbine and tri-weekly cisplatin as
      induction therapy and subsequent concomitantly with radiotherapy (RT) in patients with lung
      cancer (NSCLC) locally advanced unresectable
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients with histologically confirmed recent non small cell lung cancer unresectable
             stage IIIA and IIIB.

          -  Perform a baseline positron emission tomography (PET-CT) to rule out the presence of
             distant disease and confirm that it is a non-NSCLC radical surgical treatment
             candidate.

          -  The positive mediastinal lymph nodes by PET-CT must be confirmed histologically.
             Mediastinal involvement may be considered without histologically observe when there is
             a mass of lymph nodes where the margins are not distinguished.

          -  At least one measurable lesion on computerized tomography (CT).

          -  Performance status 0-1.

          -  Life expectancy> 12 weeks.

          -  Age ≥18 years and ≤ 75 years.

          -  Right renal function: creatinine ≤ 1.5 mg / dl or creatinine clearance> 60 ml / min.

          -  Right hematologic function: hemoglobin> 10 g / dl, neutrophils ≥ 1500 / mm3 and
             platelets ≥ 100,000 / mm3.

          -  Right hepatic function: bilirubin ≤ 1.5 times the upper limit of each center,
             transaminases ≤ 2.5 above the normal limit.

          -  Right lung function without bronchodilators: defined by a forced expiratory volume in
             1 second (FEV1)> 50% of predicted normal volume and lung diffusing capacity for carbon
             monoxide (DLCO)> 40% of predicted normal.

          -  The proportion of normal lung exposed to> 20 Gy RT (V20) shall be ≤ 35%.This must be
             fulfilled before the start of treatment cycle 3.

          -  Signature of informed consent.

        Exclusion Criteria:

          -  Weight loss> 10% in the 3 months prior to study entry.

          -  Intestinal problems that do not ensure proper absorption of oral vinorelbine.

          -  Pregnant or lactating women. Women of childbearing potential should have a negative
             pregnancy test, and both men and women under this condition should take contraceptive
             measures throughout the study.

          -  symptomatic sensory neuropathy> grade 1 toxicity criteria according to the CTCAE v4.

          -  Comorbidities uncontrolled.

          -  syndrome of the superior vena cava.

          -  pleural or pericardial effusion: are both considered as indicative of metastatic
             disease unless proven otherwise. Those who still remain cytologically negative for
             malignancy, are exudates also be excluded. It may include those with pleural effusion
             visible on chest radiography or too small to perform diagnostic puncture safely.

          -  Known hypersensitivity to drugs with similar study drug structure.

          -  Previous treatment with anticancer drugs, previous surgery or thoracic radiotherapy
             for lung cancer or for other reasons.

          -  History of other malignancy treated properly within 5 years except carcinoma in situ
             of the cervix or breast skin and basal cell carcinoma.

          -  Concomitant treatment with other antineoplastic drug or investigational.

          -  Patients at any psychological, family, sociological or geographical that may hinder
             compliance with the study protocol and monitoring program.

          -  history of neurological or psychiatric disorders that impede a properly understanding
             of the informed consent.