Status:
COMPLETED
Concurrent Chemoradiotherapy (CCRT) With Paclitaxel Plus Cisplatin in LA Non-small-cell Lung Cancer (NSCLC)
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Present study is to investigate efficacy and toxicity profiles of induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consoli...
Detailed Description
Lung cancer is a major cause of cancer death in Taiwan and throughout the world in both developed and developing countries. More than 75% of NSCLC patients are inoperable because of either distantly m...
Eligibility Criteria
Inclusion
- Histologic or cytological diagnosis of inoperable locally advanced (stage III) NSCLC.
- No prior chemotherapy, immunotherapy, or radiotherapy.
- Performance status of 0 to 2 on the Zubrod scale.
- Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by computerized tomography (CT) scan, magnetic resonance imaging (MRI), or chest x-ray.
- Estimated life expectancy of at least 12 weeks.
- Patient compliance and geographic proximity that allow adequate follow-up.
- Adequate bone marrow reserve: white blood cell (WBC) count \*4,000/mm3, platelets \>100,000/mm3, and hemoglobin \*10 g/dL.
- Informed consent from patient.
- Males or females 18 years of age or older.
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device \[IUD\], birth control pills, or barrier device) during and for three months after trial.
Exclusion
- Active infection (at the discretion of the investigator).
- Inadequate liver function (total bilirubin \>1.5 times above normal range); alanine transaminase (ALT) and aspartate transaminase (AST) greater than 3 times normal (ALT and AST may be elevated to 5 times normal in patients with known metastatic disease in the liver).
- Inadequate renal function (creatinine \>2.0 mg/dL).
- Pregnancy or not using appropriate birth control during the study.
- Breast feeding.
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- Use of any investigational agent in the month before enrollment into the study.
- Patients with leukemia and/or a secondary primary carcinoma except for patients who have had curative therapy to basal cell carcinoma.
- Concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as previously noted for radiation.
- Active cardiac disease requiring therapy for failure, angina, and/or arrhythmias; infarctions within the preceding six months (exception: any patient whose cardiac failure is compensated on medications).
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00686322
Start Date
April 1 2008
End Date
October 1 2009
Last Update
September 15 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Taipei VGH
Taipei, Taiwan