Locally Advanced Trial of Tri-weekly Metronomic Oral Vinorelbine and Cisplatin as Induction Therapy and Subsequent Concomitance With Radiation Therapy in Patients With Unresectable Non Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2019-12-16
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Lung Cancer Group
• Treatments: Cisplatin; Vinblastine; Vinorelbine

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.