Status:
UNKNOWN
Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Lung Cancer
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-ra...
Detailed Description
OBJECTIVES: Primary * Compare the progression-free survival of patients with stage II or III unresectable non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy with or wi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer
- Stage II or III disease
- Not amenable to surgery
- Measurable or evaluable disease
- No T4 apical localization
- Lesions able to be covered in a 60 Gy minimum volume of radiation
- No pleural effusion
- PATIENT CHARACTERISTICS:
- Age
- 18 to 79
- Performance status
- ECOG 0-2
- Life expectancy
- More than 3 months
- Hematopoietic
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- Renal
- Creatinine \< 1.25 times ULN
- Cardiovascular
- No unstable heart disease
- Pulmonary
- No ventilation dysfunction that would preclude radiotherapy
- Other
- No weight loss of 15% or more within the past 2 months
- No uncontrolled infection
- No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- More than 6 months since prior neoadjuvant chemotherapy
- No prior adjuvant chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- No prior radiotherapy
- Surgery
- Not specified
- Other
- No other concurrent clinical trial participation
Exclusion
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00077220
Start Date
June 1 2002
Last Update
February 9 2009
Active Locations (68)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier d'Annecy
Annecy, France, 74011 Cedex
2
Institut Sainte Catherine
Avignon, France, 84082
3
Hopital Duffaut
Avignon, France, 84902
4
Centre Hospitalier Bayeux
Bayeux, France, 14400