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Completed

NCT Number: NCT01029678

Concomitant Radio-chemotherapy in the Elderly

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Brest, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin IV

Drug

Cisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36)

Vinorelbine

Drug

Vinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36

Radiotherapy

Radiation

66Gy, 33 fractions, 6 week

Primary outcomes

  1. Acute toxicity

    Time frame: during treatment and during the 4 weeks following the end of treatment

Secondary outcomes

  1. Late toxicity

    Time frame: 6 months after the end of the treatment

  2. Overall response rate

    Time frame: 4 weeks after treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Collaborators

  • Pierre Fabre Laboratories

Registry information

Official study title

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

Acronym: RACCOSA

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Dec 10, 2009
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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