Clinical trial · Interventional
Concomitant Radio-chemotherapy in the Elderly
Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC
NCT01029678CI-TRIAL-00032757RACCOSAcompletedPhase 2ClinicalTrials.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)
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.
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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin IV | Drug | Cisplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental
- interventionNames
- Drug: Cisplatin IV
- Drug: Vinorelbine
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- during treatment and during the 4 weeks following the end of treatment
Secondary outcomes (2)
- measure
- Late toxicity
- timeFrame
- 6 months after the end of the treatment
- measure
- Overall response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.