NCT00174772

Brief 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). 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_2

Geographic Reach
8 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

Enrollment Period

4.9 years

First QC Date

September 12, 2005

Last Update Submit

February 15, 2010

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

  • anti-tumor activity including overall response rate

    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

    throughout the study

  • other adverse events not reported in the NCI-CTI scale

    throughout the study

  • hematological and non-hematological toxicities

    reported for all grades observed during each cycle

Study Arms (2)

B

EXPERIMENTAL

Concurrent chemoradiotherapy followed by consolidation chemotherapy

Drug: docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin

A

EXPERIMENTAL

Induction chemotherapy followed by concurrent chemoradiotherapy

Drug: docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy

Interventions

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

A
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.

B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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
  • +13 more criteria

You may not qualify if:

  • 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
  • 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.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Sanofi-Aventis Administrative Office

Diegem, Belgium

Location

Sanofi-Aventis Administrative Office

Helsinki, Finland

Location

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Milan, Italy

Location

Sanofi-Aventis Administrative Office

Gouda, Netherlands

Location

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

Sanofi-Aventis Administrative Office

Istanbul, Turkey (Türkiye)

Location

Sanofi-Aventis Administrative Office

Guildford, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 16168828BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

DocetaxelCisplatinRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Study Officials

  • Jean-Philippe Aussel

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

March 1, 2004

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 17, 2010

Record last verified: 2010-02

Locations

IT(1)FR(1)FI(1)GB(1)BE(1)ES(1)NL(1)TU(1)