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Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC


Phase 2
70 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC


Inclusion Criteria:



- Age ≥ 70 years

- Independent patients (based on the score of geriatric frailty: IADL = 0, ADL = 0, no
geriatric syndrome, low comorbidity (comorbidity index of Charlson to 3 or 4),
depression score 0-1)

- Performance Status (ECOG) ≤ 1

- Weight loss <10% of usual weight in the last 3 months

- Life expectancy greater than 12 weeks

- Hematologic function: neutrophils> 1.5 x 10**9 / l, hemoglobin> 9.5 g / dl, platelets
> 100 x 10**9 / l)

- Renal function: creatinine clearance ≥ 50 ml / min calculated by the formula of MDRD

- Normal liver function: bilirubin < Limit of Normal (ULN), SGOT and / or SGPT <2.5 x
UNL

- Respiratory Function: FEV ≥ 40% predicted, PaO2 ≥ 60 mm Hg, KCO ≥ 60% predicted

- Patient affiliated to a social security regimen or beneficiary of such regimen

- Informed consent signed

The disease

- Pathological anatomy: CBP non-small cell (squamous cell carcinoma, adenocarcinoma,
large cell carcinoma, undifferentiated carcinoma) histologically or cytologically
proven

- Stage IIIAN2 considered inoperable stage IIIB

- Presence of at least one measurable target

- Delay at least three weeks between surgery and initiation of treatment

- No prior treatment with chemotherapy or radiotherapy for lung cancer

Exclusion Criteria:

- Age < 70 years

- Performance Status (ECOG) ≥ 2

- Hematologic function: neutrophils <1.5 x 10**9 / l, hemoglobin <9.5 g / dl, platelets
<100 x 10**9 / l)

- Renal function: creatinine clearance <50 ml / min calculated by the formula of MDRD

- Hepatic: bilirubin> Upper Limit of Normal (ULN), SGOT and / or SGPT> 2.5 x ULN

- Respiratory Function: FEV <40% predicted, KCO <60% predicted, PaO2 <60 mmHg

- Peripheral neuropathy grade> 1

- Unstable cardiac pathology requiring treatment (heart failure, angor of effort,
arrhythmia) or previous myocardial infarction older than 12 months

- Deafness not paired or deafness requiring major achievement of an audiogram-cons may
indicate taking cisplatin

- Neurological or psychiatric disorders prohibiting the understanding of the test

- Previous history of cancer except basal cell cancer, carcinoma in situ of the cervix
treated or any other cancer treated with surgery alone or radiotherapy alone
extra-thoracic recurrence-free 5 years

- Significant malabsorption syndrome or disease affecting the functioning of the
gastrointestinal tract

The disease

- Pathological anatomy: Bronchioloalveolar carcinoma, neuroendocrine carcinoma, small
cell carcinoma

- Metastatic disease

- Pleural drain

- Carcinomatous lymphangitis

- Operable Cancer

- Previously treated for lung cancer disease: radiotherapy, chemotherapy, hormonal
therapy, endobronchial suctioning older less than eight days

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute toxicity

Outcome Time Frame:

during treatment and during the 4 weeks following the end of treatment

Safety Issue:

Yes

Principal Investigator

Chrystèle LOCHER, MD

Investigator Role:

Study Chair

Investigator Affiliation:

CH Meaux

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

I08011

NCT ID:

NCT01029678

Start Date:

January 2010

Completion Date:

January 2015

Related Keywords:

  • Non Small Cell Lung Cancer
  • Locally advanced lung cancer
  • Elderly patients
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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