Clinical trial NCT01029678: Concomitant Radio-chemotherapy in the Elderly
Official title: Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Locally advanced lung cancer
Elderly patients
NSCLC
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Pierre Fabre Laboratories
First posted: 2009-12-10
Enrollment: 48
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC) treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant radiotherapy in elderly patients.


Eligibility criteria: 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

Primary outcomes:
measure: Acute toxicity
timeFrame: during treatment and during the 4 weeks following the end of treatment
Secondary outcomes:
measure: Late toxicity
timeFrame: 6 months after the end of the treatment
measure: Overall response rate
timeFrame: 4 weeks after treatment
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
city: GAP
country: France
facility: Centre Hospitalier GAP
city: Limoges
country: France
facility: Département de Pathologie Respiratoire du CHU de Limoges
city: Meaux
country: France
facility: CH de Meaux
city: Reims
country: France
facility: CHU Reims
Study officials:
affiliation: CH Meaux
name: Chrystèle LOCHER, MD
role: STUDY_CHAIR
References: