Lung NeoplasmsPhase 2NCT00174772
Pulmonart: Docetaxel - Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy and docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin in people with Lung Neoplasms, run by Sanofi at 8 sites in 8 countries.
Trial summary
Primary Objective: To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC (stage IIIA- multiple cN2 or IIIB). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy and docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Mar 2004to Feb 2009
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
- Patients must have a locoregionally advanced unresectable NSCLC
- Stage IIIA with multiple level clinical N2 nodes (preferably with histological or cytological confirmation).
- Patients with peripheral tumours of the lower lobe with contralateral upper mediastinal nodes at station N2 are excluded
- Stage IIIB T4 or N3
- In the T4 category, patients with pleural or pericardial effusion and multiple nodules in the same lobe are excluded.
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- Patients with T4 disease secondary to extensive and massive involvement of the great vessels are excluded.
- Patients should be excluded when the expected risk of pulmonary toxicity is likely to be high, e.g. V20 in excess of 35%.
- Life expectancy of at least 12 weeks.
- WHO performance status 0 or 1.
- Weight loss ≤ 10% within the last 3 months.
- Laboratory requirements at entry (within 7 days before randomization):
- Blood cell counts:
- Absolute neutrophils ≥ 2.0 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 10 g/dl
- Renal function:
- Serum creatinine ≤1 x the upper limit of normal (UNL). In case of borderline value of serum creatinine, the 24h creatinine clearance should be ≥ 60 mL/min
- Hepatic functions:
- Serum bilirubin ≤ 1 x UNL
- ASAT and ALAT ≤ 2.5 x UNL
- Alkaline phosphatase ≤ 5 x UNL.
- Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.
- Lung function tests at entry:
- FEV1: ≥ 50 % x Normal value
- DLco: ≥ 50 % x Normal value.
- Adequate cardiac function.
- Patient with either measurable and/or non-measurable lesion (according to RECIST criteria).
Who cannot join
- Diagnosis of small cell lung cancer
- Pregnant or lactating women
- Patients (male or female) with reproductive potential not implementing adequate contraceptive measures
- Prior systemic chemotherapy, immunotherapy, or biological therapy including neoadjuvant or adjuvant treatment for NSCLC
- Prior surgery for NSCLC, if less than 5 years from study
- Prior radiotherapy for NSCLC
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- History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
- Symptomatic peripheral neuropathy Grade ≥ 2 except if due to trauma.
- Other serious concomitant illness of medical conditions:
- Congestive heart failure or angina pectoris except if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias.
- History of significant neurologic or psychiatric disorders including dementia or seizures.
- Active infection requiring IV antibiotics.
- Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy.
- Superior vena cava syndrome contra-indicating hydration.
- Preexisting pericardial effusion.
- Preexisting symptomatic pleural effusion.
- Significant gastrointestinal abnormalities, including requirement for intravenous nutrition, active peptic ulcer disease, prior surgical procedures affecting absorption.
- Distant metastasis.
- Concurrent treatment with any other experimental anti-cancer drugs.
- Concomitant or within 4-week period administration of any other experimental drug under investigation.
- Significant ophthalmologic abnormalities.
- Moderate to severe dermatitis.
- Hypersensitivity to docetaxel or any of its excipients.
- Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.
- Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: A Two Arm Phase II Study Comparing Docetaxel/Cisplatin Induction Therapy Followed By Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Followed By Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-Multiple cN2 or IIIB)
Primary Objective:
- To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC (stage IIIA- multiple cN2 or IIIB).
Secondary Objective:
- To estimate efficacy parameters in overall response rate, progression free survival and 1 year survival for each of the two above mentioned arms.
- Conditions
- Lung Neoplasms
- Being tested
- docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy, docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapyDrug
docetaxel (75mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemoradiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy
docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatinDrug
docetaxel (20mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | Concurrent chemoradiotherapy followed by consolidation chemotherapy Receives: Drug: docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin |
| A | Experimental | Induction chemotherapy followed by concurrent chemoradiotherapy Receives: Drug: docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-tumor activity including overall response rate
Measured: assessed at the end of the full course of treatment period
Secondary outcomes (3)
all treatment related acute and chronic toxicity assessed according to the NCI-CTC scale
Measured: throughout the study
other adverse events not reported in the NCI-CTI scale
Measured: throughout the study
hematological and non-hematological toxicities
Measured: reported for all grades observed during each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Philippe Aussel, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174772
- Sponsor's protocol ID
- XRP6976B_2505
- Status last verified
- Feb 2010
- First submitted
- 12 Sep 2005
- Last updated
- 17 Feb 2010
- Results posted
- No
Publications
van Sornsen de Koste JR, Senan S, Underberg RW, Oei SS, Elshove D, Slotman BJ, Lagerwaard FJ. Use of CD-ROM-based tool for analyzing contouring variations in involved-field radiotherapy for Stage III NSCLC. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):334-9. doi: 10.1016/j.ijrobp.2005.02.016.
PubMed 16168828
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Arm Phase II Study Comparing Docetaxel/Cisplatin Induction Therapy Followed By Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Followed By Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-Multiple cN2 or IIIB)
- ClinicalTrials.gov ID
- NCT00174772
- Acronym / sponsor ID
- XRP6976B_2505
- Conditions
- Lung Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 15 Sep 2005 (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.
Primary Objective:
- To evaluate the toxicity/safety profile of docetaxel/cisplatin induction therapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by consolidation docetaxel/cisplatin in patients with locally advanced unresectable NSCLC (stage IIIA- multiple cN2 or IIIB).
Secondary Objective:
- To estimate efficacy parameters in overall response rate, progression free survival and 1 year survival for each of the two above mentioned arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Drug: docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatinConcurrent chemoradiotherapy followed by consolidation chemotherapy |
| A | Experimental | Drug: docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapyInduction chemotherapy followed by concurrent chemoradiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma or a combination of these)
- Patients must have a locoregionally advanced unresectable NSCLC
- Patients should be excluded when the expected risk of pulmonary toxicity is likely to be high, e.g. V20 in excess of 35%.
- Life expectancy of at least 12 weeks.
- WHO performance status 0 or 1.
Key exclusion criteria (27 listed)
- Diagnosis of small cell lung cancer
- Pregnant or lactating women
- Patients (male or female) with reproductive potential not implementing adequate contraceptive measures
- Prior systemic chemotherapy, immunotherapy, or biological therapy including neoadjuvant or adjuvant treatment for NSCLC
- Prior surgery for NSCLC, if less than 5 years from study
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 |
|---|---|---|
| docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapydocetaxel (75mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemoradiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy | Drug | A |
| docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatindocetaxel (20mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles. | Drug | B |
Primary outcome
anti-tumor activity including overall response rate
Time frame: assessed at the end of the full course of treatment period
3 secondary outcomes
all treatment related acute and chronic toxicity assessed according to the NCI-CTC scale
Time frame: throughout the study
other adverse events not reported in the NCI-CTI scale
Time frame: throughout the study
hematological and non-hematological toxicities
Time frame: reported for all grades observed during each cycle
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 17 Feb 2010.
- Background: PubMed 16168828van Sornsen de Koste JR, Senan S, Underberg RW, Oei SS, Elshove D, Slotman BJ, Lagerwaard FJ. Use of CD-ROM-based tool for analyzing contouring variations in involved-field radiotherapy for Stage III NSCLC. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):334-9. doi: 10.1016/j.ijrobp.2005.02.016.
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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.
Jean-Philippe Aussel study director
Sanofi
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy and docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin in people with Lung Neoplasms, run by Sanofi at 8 sites in 8 countries.
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 28 inclusion and 27 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 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Finland, France, Italy, Netherlands and 3 more countries. 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?
anti-tumor activity including overall response rate (time frame: assessed at the end of the full course of treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00174772, which also lists 1 linked publication.
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 17 Feb 2010.