Concurrent Chemoradiotherapy (CCRT) With Paclitaxel Plus Cisplatin in LA Non-small-cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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 consolidation chemotherapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).