Lung Cancer Clinical Trial
Official title:
Multimodality Therapy for Stages II and III Non-Small Cell Lung Cancer: Surgical Resection Followed by Sequential Administration of Gemcitabine Plus Cisplatin Chemotherapy and Radiation Therapy
Verified date | October 2015 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) together with radiation
therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well surgery followed by gemcitabine,
cisplatin, and radiation therapy works in treating patients with stage II or stage III
non-small cell lung cancer.
Status | Terminated |
Enrollment | 3 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed single, primary bronchogenic non-small cell lung cancer meeting the following subtypes: - Adenocarcinoma (no bronchioalveolar cell histology) - Squamous cell carcinoma - Large cell carcinoma - Meeting the following staging criteria: - Stage IIB (T2, N1, M0, or T3, N0, M0) - Stage IIIA (T1-3, N2, M0 or T3, N1, M0) - Stage IIIB (Any T, N3, M0 or T4, Any N, M0) - No more than 1 parenchymal lesion in the same lung or in both lungs - No tumor involving the superior sulcus (e.g., Pancoast tumor) - Patients must undergo evaluation by the involved thoracic surgeon, medical oncologist, and radiation oncologist prior to registration - No evidence of metastatic disease - Biopsy or aspiration cytology required to confirm the benign diagnosis of CT or MRI abnormalities that potentially represent metastatic disease - Biopsy required if all noninvasive tests are indeterminant PATIENT CHARACTERISTICS: - Karnofsky performance status 70-100% - Absolute granulocyte count = 1,500/µL - Platelet count = 100,000/µL - Bilirubin = 3 times upper limit of normal (ULN) - SGOT and SGPT = 3 times ULN - Creatinine clearance > 50 mL/min - No prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, or any other cancer from which the patient has been disease-free for 5 years - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective protection - No significant hearing loss or patient unwilling to accept potential for further hearing loss - No uncontrolled medical illness by appropriate medical therapy (e.g., myocardial infarction within the past 3 months or liver cirrhosis) - No symptomatic peripheral neuropathy affecting activities of daily living PRIOR CONCURRENT THERAPY: - No prior chemotherapy or radiotherapy for lung cancer |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Two-year Progression-free Survival From the Date of Surgery | Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 25% increase or an increase of 10 cm2 (whichever is smaller) in the sum of the products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation or death, or deteriorating condition (unless clearly unrelated to this cancer). | 2 years post-surgery | No |
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