Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.

Non-Small-Cell Lung Carcinoma Clinical Trial

Official title:

Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148395
• Other study ID #: NSCLC 06/2001
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: April 21, 2008
• Start date: June 2002
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: Aktion Bronchialkarzinom e.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study wants to assess different intensive therapy sequences for the treatment of non-small-cell lung cancer.

It claims less on the efficacy of different chemotherapy combinations, than more on the comparison of different strategies of sequential single-agent, sequential double-agent or sequential triple-agent therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histological verified non-small cell lung cancer. Cytological diagnosis is accepted for doubtless results.

2. Present stage IIIb with malignant pleural effusion or stage IV disease. Tumor dissemination should not be irradiable in one field

3. Age between 18 and 75 years

4. Karnofsky index 70 - 100%

5. Measurable or evaluable tumor parameter

6. No prior chemotherapy for NSCLC

7. Sufficient hematological parameter before start of therapy (leucocytes > 3.500/µl and platelets > 100.000/µl).

8. Sufficient liver function (bilirubin < 1,6mg/dl)

9. Sufficient renal function (creatinine < 1,5mg/dl and clearance > 60ml/min)

10. Minimal estimated life expectancy > 3 months

11. Written informed consent for study attendance

12. Patient accessibility for therapy and follow up

13. No attendance to an other study

Exclusion Criteria:

1. Small-cell lung cancer oder tumors with small-cell fractions

2. Local advanced irradiable stage III

3. Previous chemotherapy because of other diseases, not longer than 3 years ago

4. Simultaneous radiation of all present tumor manifestations

5. Simultaneous or not longer than 3 years ago secondary malignancy, except carcinoma in situ of the cervix or dermal cancer, others than melanoma

6. Respiratory insufficiency

7. Heart insufficiency NYHA III and IV

8. Peripheral arteriosclerosis stage III and IV

9. Neurological and psychiatric diseases, which affect understanding of the study concept and the possibility to keep conditions of the protocol

10. Pregnancy, breastfeeding or not ensured contraception

11. HIV-infection

12. Active hepatitis B and C

13. Manifest infectious diseases before start of therapy

14. Minimal estimated life expectancy < 3 months

15. No written informed consent of the patient for study attendance and storage and disclosure of disease data according to the protocol

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• Gemcitabine

• Navelbine

• Carboplatin

• Cisplatin

• Mitomycin

• Ifosfamide

Locations

Country	Name	City	State
Germany	Klinikum Kassel GmbH	Kassel

Sponsors (1)

Lead Sponsor	Collaborator
Aktion Bronchialkarzinom e.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	Event-free survival
Secondary	Quality of live