Clinical trial · Interventional
Study of Vinorelbine and Cisplatin as Induction Therapy With Radiotherapy in Patients With Unresectable NSCLC
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
NCT02709720CI-TRIAL-00072914NORAcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1 Experimental group
- description
- 2 cycles of metronomic Vinorelbine 50 mg + cisplatin, followed by 2 cycles of Vinorelbine 30 mg + cisplatin concomitant with radiotherapy Induction chemotherapy: * Cisplatin: 80 mg/m2 day 1 every 21 days, for 2 cycles. * Metronomic oral vinorelbine: 50mg/day, 3 days of each week for 2 cycles. Concomitant chemotherapy and radiotherapy: * Cisplatin: 80 mg/m2 day 1 every 21 days, for 2 cycles. * Metronomic oral vinorelbine: 30mg/day, 3 days of each week for 2 cycles. 1 cycle equals 21 days Radiotherapy treatment: Patients will receive concomitant thoracic radiation therapy, using a technique three-dimensional conformal radiation therapy, using an accelerator linear that operates with energy rays ≥ 6 MV. The total target RTT dose will be 66 Gy in 33 daily fractions of 2 Gy, which will be prescribed in accordance with the document of ICRU reference 50 of ICRU.
- interventionNames
- Drug: Vinorelbine
- Drug: Cisplatin
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- From patient inclusion up to the date of first documented progression or date of death from any cause, whichever came first, up to 24 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTProvencio M, Majem M, Guirado M, Massuti B, de Las Penas R, Ortega AL, Domine M, Marse R, Sala MA, Paredes A, Moran T, Vazquez S, Coves J, Larriba JLG, Sanchez JM, Vicente D, Farre N, Fornos LF, Zapata I, Franco F, Serna-Blasco R, Romero A, Isla D. Phase II clinical trial with metronomic oral vinorelbine and tri-weekly cisplatin as induction therapy, subsequently concomitant with radiotherapy (RT) in patients with locally advanced, unresectable, non-small cell lung cancer (NSCLC). Analysis of survival and value of ctDNA for patient selection. Lung Cancer. 2021 Mar;153:25-34. doi: 10.1016/j.lungcan.2021.01.005. Epub 2021 Jan 10. PMID 33453470