Study of Vinorelbine and Cisplatin as Induction Therapy With Radiotherapy in Patients With Unresectable NSCLC

NCT02709720 | Completed Phase 2 Results DMC

• 2 other identifiers: GECP 15/02_NORA2015-003312-21
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 18

Brief 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

Conditions

Lung Cancer

Keywords

Lung Cancer; Cancer Lung Disease; NORA; GECP 15/02; Metronomic administration

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  To evaluate the efficacy in terms of progression-free survival (PFS) of oral metronomical vinorelbine and cisplatin as an induction treatment and then with concomitant radiotherapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions The PFS is defined as the time from the moment of patient inclusion to the documentation of progression or death from any cause (patients who die without evidence of progression, will be considered events on the date of death).

  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.

Secondary Outcomes (2)

• Objective Response Rate 6 Month

  From the start of the treatment of the patient to 6 month afther the treatment end

• Overall Survival (Estimated)

  From the date of randomization until end of follow up or death, up to 24 months.

Study Arms (1)

1 Experimental group

EXPERIMENTAL

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.

Drug: Vinorelbine; Drug: Cisplatin; Radiation: Radiotherapy

Interventions

Vinorelbine DRUG

Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)

Also known as: Navelbine

1 Experimental group

Cisplatin DRUG

Cycle 1 and 2 day 1, 80 mg/m2

1 Experimental group

Radiotherapy RADIATION

concomitant therapy during cycles 3 and 4. Total dose: 66Gy

1 Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Lung Cancer Group: lead

Study Sites (18)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

ICO-Badalona

Badalona, Barcelona, 08916, Spain

Location

Hospital Provincial de Castellón

Castellon, Castelló, 12002, Spain

Location

H. Son Espases

Palma de Mallorca, Mallorca, 07014, Spain

Location

Hospital Lluís Alcanyís

Xàtiva, Valencia, 46800, Spain

Location

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

H.G.U. Alicante

Alicante, 03010, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

H. de Donostia

Donostia / San Sebastian, 20014, Spain

Location

Hospital de Jaén

Jaén, 23007, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

H. de la Princesa

Madrid, 28006, Spain

Location

H.U. Puerta de Hierro

Madrid, 28035, Spain

Location

Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

H. Clínico San Carlos

Madrid, Spain

Location

H. Son Llàtzer

Palma de Mallorca, 07198, Spain

Location

Hospital Virgen de La Macrena

Seville, 41009, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (1)

• Provencio 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 RESULT

Related Links

• Web page of the sponsor where users can find more information about Fundación GECP studies

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Vinorelbine; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Results Point of Contact

• Title: Eva Pereira
• Organization: Fundación GECP

gecp@gecp.org

+34934302006

Study Officials

• Mariano Provencio, MD

  Hospital Puerta de Hierro

  STUDY CHAIR

• Bartomeu Massutí, MD

  Hospital General Universitario de Alicante

  PRINCIPAL INVESTIGATOR

• Teresa Morán, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

• José Luis González Larriba, MD

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

• Manuel Dómine, MD

  Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

• José Miguel Sánchez, MD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

• Ramón de las Peñas, MD

  Hospital Provincial de Castellón

  PRINCIPAL INVESTIGATOR

• María Guirado, MD

  Hospital Gnral de Elche

  PRINCIPAL INVESTIGATOR

• Dolores Isla, MD

  Hospital Lozano Blesa

  PRINCIPAL INVESTIGATOR

• Raquel Marsé, MD

  Hospital Son Espases

  PRINCIPAL INVESTIGATOR

• Mª Angeles Sala, MD

  Hospital de Basurto

  PRINCIPAL INVESTIGATOR

• Juan Coves, MD

  Hospital Son Llátzer

  PRINCIPAL INVESTIGATOR

• Ana Laura Ortega, MD

  Hospital de Jaén

  PRINCIPAL INVESTIGATOR

• David Vicente, MD

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

• Regina Gironés, MD

  Hospital LLuís Alcanyís

  PRINCIPAL INVESTIGATOR

• Alfredo Paredes, MD

  Hospital de Donostia

  PRINCIPAL INVESTIGATOR

• Margarita Majem, MD

  Hospital Sant Pau i de la Santa Creu

  PRINCIPAL INVESTIGATOR

• Sergio Vázquez, MD

  Hospital Lucus Agustí

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: March 16, 2016
• Study Start: April 15, 2016
• Primary Completion: April 15, 2019
• Study Completion: December 16, 2019
• Last Updated: January 11, 2024
• Results First Posted: January 11, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (18)