Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer
A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer.
1 other identifier
interventional
227
1 country
21
Brief Summary
The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2003
Typical duration for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJuly 16, 2025
November 1, 2007
3.5 years
September 14, 2005
July 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
1-Complete response
2-Partial response
3-Stable disease
4-Progression
Secondary Outcomes (1)
-Toxicity (NCI-CTC criteria)
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
- Metastatic relapses allowed in not irradiated area.
- Age between 18 and 70 years
- Chemonaïve patients
- At least one measurable target lesion according to recist criteria in non previously irradiated area.
- Performance status \< 2
- Normal hepatic and renal function, absolute neutrophil count \>1,5 giga/l, platelets \>100 giga/l.
- Written informed consent.
- Life expectancy \> 12 weeks.
You may not qualify if:
- SCLC, bronchial-alveolar and neuro-endocrine carcinoma.
- Previous chemotherapeutic treatment.
- Symptomatic brain metastases.
- Superior vena cava syndrome.
- Other concomitant diseases: heart failure, angina pectoris, arrhythmia , recent myocardial infarction.
- Peripheral neuropathy grade ≥2.
- Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
- Hypersensitivity to paclitaxel or polysorbate 80.
- Pregnancy or breast feeding.
- Any concomitant radiotherapy, except palliative bone irradiation.
- Follow-up of the patient impossible.
- Prisoners.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Service de Pneumologie
Beauvais, France
Service de Pneumologie
Bordeaux, France
Service de Pneumologie
Charleville Mezière, France
Service de Pneumologie
Créteil, France
Service de Pneumologie
Draguignan, France
Service de Pneumologie
Elbeuf, France
Service de Pneumologie
Gap, France
Service de Pathologie Respiratoire
Limoges, France
Service de Pneumologie, Hôpital de la Croix Rousse
Lyon, France
Service de Pneumologie
Mantes-la-Jolie, France
Département des Maladies Respiratoires
Marseille, France
Service de Pneumologie-Allergologie
Martigues, France
Service de Pneumologie
Meaux, France
Service de Pneumologie
Mulhouse, France
Service de Pneumologie - Hôpital St Antoine
Paris, France
Service de Pneumologie, Hôpital Pontchailloux
Rennes, France
Hôpital Charles Nicolle, Service de Pneumologie
Rouen, France
Service de Pneumologie, Hôpital Bois Guillaume
Rouen, France
Service de Pneumologie, Hôpital Nord
Saint-Etienne, France
Service de Pathologie Respiratoire
Toulon Naval, France
Service de Pneumologie
Villefranche, France
Related Publications (1)
Vergnenegre A, Tillon J, Corre R, Barlesi F, Berard H, Vernejoux JM, Le Caer H, Fournel P, Marin B, Chouaid C. A randomized phase II trial assessing in advanced non-small cell lung cancer patients with stable disease after two courses of cisplatin-gemcitabine an early modification of chemotherapy doublet with paclitaxel-gemcitabine versus continuation of cisplatin-gemcitabine chemotherapy (GFPC 03-01 Study). J Thorac Oncol. 2009 Mar;4(3):364-70. doi: 10.1097/JTO.0b013e318197f4ff.
PMID: 19155999BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Vergnengre, MD
University Hospital, Limoges
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 20, 2005
Study Start
September 1, 2003
Primary Completion
March 1, 2007
Study Completion
June 1, 2007
Last Updated
July 16, 2025
Record last verified: 2007-11