Non Small Cell Lung CancerPhase 2RACCOSANCT01029678
Concomitant Radio-chemotherapy in the Elderly
A Phase 2 study testing Cisplatin IV, Vinorelbine and Radiotherapy in people with Non Small Cell Lung Cancer, run by University Hospital, Limoges at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Cisplatin IV, Vinorelbine and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesFrance
- Study dates
- Jan 2010to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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 109 / l, hemoglobin> 9.5 g / dl, platelets > 100 x 109 / l)
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- 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
Who cannot join
- Age < 70 years
- Performance Status (ECOG) ≥ 2
- Hematologic function: neutrophils <1.5 x 109 / l, hemoglobin <9.5 g / dl, platelets <100 x 109 / 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Brest
Brest
Centre Hospitalier GAP
Gap
Département de Pathologie Respiratoire du CHU de Limoges
Limoges
CH de Meaux
Meaux
CHU Reims
Reims
About this study
Official title: Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC
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
- Non Small Cell Lung Cancer
- Being tested
- Cisplatin IV, Vinorelbine, Radiotherapy
- Keywords
- Locally advanced lung cancer, Elderly patients, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin IVDrug
Cisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36)
VinorelbineDrug
Vinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36
RadiotherapyRadiation
66Gy, 33 fractions, 6 week
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Not described Receives: Drug: Cisplatin IV; Drug: Vinorelbine; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
Measured: during treatment and during the 4 weeks following the end of treatment
Secondary outcomes (2)
Late toxicity
Measured: 6 months after the end of the treatment
Overall response rate
Measured: 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre Fabre Laboratories
- Responsible party
- Sponsor
- Investigators
- Chrystèle LOCHER, MD, Study chair, CH Meaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029678
- Sponsor's protocol ID
- I08011
- Acronym
- RACCOSA
- Status last verified
- Jan 2018
- First submitted
- 9 Dec 2009
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC
- ClinicalTrials.gov ID
- NCT01029678
- Acronym / sponsor ID
- RACCOSA / I08011
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Locally advanced lung cancer, Elderly patients, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Pierre Fabre Laboratories
- Study start
- Jan 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: Cisplatin IV, Drug: Vinorelbine, Radiation: Radiotherapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (19 listed)
- Age < 70 years
- Performance Status (ECOG) ≥ 2
- Hematologic function: neutrophils <1.5 x 109 / l, hemoglobin <9.5 g / dl, platelets <100 x 109 / 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisplatin IVCisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36) | Drug | experimental |
| VinorelbineVinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36 | Drug | experimental |
| Radiotherapy66Gy, 33 fractions, 6 week | Radiation | experimental |
Primary outcome
Acute toxicity
Time frame: during treatment and during the 4 weeks following the end of treatment
2 secondary outcomes
Late toxicity
Time frame: 6 months after the end of the treatment
Overall response rate
Time frame: 4 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chrystèle LOCHER, MD study chair
CH Meaux
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin IV, Vinorelbine and Radiotherapy in people with Non Small Cell Lung Cancer, run by University Hospital, Limoges at 5 sites in France.
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 17 inclusion and 19 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 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute toxicity (time frame: during treatment and during the 4 weeks following the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2018.