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Lung CancerPhase 2NORANCT02709720

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

A Phase 2 study testing Vinorelbine, Cisplatin and Radiotherapy in people with Lung Cancer, run by Spanish Lung Cancer Group at 18 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Cancer
What is being tested?
Vinorelbine, Cisplatin and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
18 sitesSpain
Study dates
15 Apr 2016to 16 Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Spain18 sites

  • H.G.U. Alicante

    Alicante, 03010

  • ICO-Badalona

    Badalona, Barcelona, 08916

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital Provincial de Castellón

    Castellon, Castelló, 12002

  • H. de Donostia

    Donostia / San Sebastian, 20014

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital de Jaén

    Jaén, 23007

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • H. de la Princesa

    Madrid, 28006

  • H.U. Puerta de Hierro

    Madrid, 28035

  • Hospital Fundación Jiménez Díaz

    Madrid, 28040

  • H. Clínico San Carlos

    Madrid

  • H. Son Espases

    Palma de Mallorca, Mallorca, 07014

  • H. Son Llàtzer

    Palma de Mallorca, 07198

  • Hospital Virgen de La Macrena

    Seville, 41009

  • Hospital Lluís Alcanyís

    Xàtiva, Valencia, 46800

  • Hospital Clínico Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: 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 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

Read the detailed description

Hypothesis: At present, administration of concomitant chemotherapy and radiation therapy is considered a treatment of choice for patients with unresectable stage III tumor selected clinically.

There is at present a systemic considered standard treatment in combination with radical radiotherapy. Nor is it established a dose of standard radiation therapy, but it is known that should never be less than 60Gy57.

Vinorelbine has shown a strong radio-sensitizer in-vitro37 effect. In the phase II study, The combination of oral vinorelbine with cisplatin as induction therapy and then concomitantly with radiotherapy (66Gy) has provided very encouraging efficacy results. Recently in the vortex scheme cisplatin study with oral vinorelbine concomitant maintained with radiation from the second cycle of chemotherapy was tested.

It is therefore a priority in this segment pathology seeking treatment regimens that improve the effectiveness and toxicity. Metronomic chemotherapy started with the idea of administering a cytostatic divided doses, for an extended period without interruption, can provide the advantage of exposing patients to significant dose chemotherapy without worsening the toxicity profile. All this makes it an attractive treatment strategy, and can also maintain radio sensitizing effect during concomitance.

Conditions
Lung Cancer
Being tested
Vinorelbine, Cisplatin, Radiotherapy
Keywords
Lung Cancer, Cancer Lung Disease, NORA, GECP 15/02, Metronomic administration
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VinorelbineDrug

    Also called Navelbine

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

  • CisplatinDrug

    Cycle 1 and 2 day 1, 80 mg/m2

  • VinorelbineDrug

    Also called Navelbine

    Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)

  • CisplatinDrug

    Cycle 3 and 4 day 1, 80 mg/m2

  • RadiotherapyRadiation

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

Study groups in NCT02709720
Study groupRoleWhat they receive
1 Experimental groupExperimental2 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.
Receives: Drug: Vinorelbine; Drug: Cisplatin; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

  1. Objective Response Rate 6 Month

    The objective response rate will be calculated from the sum of the number of patients whose best response is complete response, partial response and stable disease divided by the total number of patients eligible for the analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

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

  2. Overall Survival (Estimated)

    Overall survival will be measured from the date of patient inclusion until death or loss of follow-up. In patients who have not died, the duration of survival will be censored on the date of the last contact if the patient causes loss of follow-up or on the date of the latest news.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2016 (estimated)
  2. Study start15 Apr 2016
  3. Primary completion15 Apr 2019
  4. Study completion16 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02709720
Sponsor's protocol ID
GECP 15/02_NORA
Other IDs
2015-003312-21, 2015
Acronym
NORA
Status last verified
Apr 2023
First submitted
2 Feb 2016
Last updated
11 Jan 2024
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 33453470

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinorelbine, Cisplatin and Radiotherapy in people with Lung Cancer, run by Spanish Lung Cancer Group at 18 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02709720, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.

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