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Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer. Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer clinical trial. Participants frequently get the best healthcare available for their Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer  Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 2 non-small cell lung cancer
Status: Recruiting
Sponsor(s): Fox Chase Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before and after surgery may shrink the tumor so it can be removed during surgery and may kill any remaining tumor cells following surgery. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advancednon-small cell lung cancer.
Details: OBJECTIVES: - Determine the complete resection rate and toxic death rate of patients with locally advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin. - Determine the survival, event-free survival, and incidence of pathologic complete remission of patients treated with this regimen. - Determine the protocol completion rate (CR) of patients treated with this regimen. - Determine the feasibility and toxicity of this regimen in these patients. - Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom from distant metastasis rate, and freedom from local regional failure rate of patients treated with this regimen. OUTLINE: Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6 weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients with resectable disease undergo surgical resection within 4-8 weeks after induction therapy. Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15. Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant treatment repeats every 4 weeks for 3 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 57 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed, newly diagnosed, unilateral primary non-small cell lung cancer (NSCLC) - Must have involvement of the superior sulcus, chest wall, or mediastinum - Must have at least 1 of the following: - Locally advanced Pancoast tumors with no documented mediastinal or supraclavicular nodal involvement (T3-T4, N0-1) - Resectable chest wall disease (T3, N0-1) - Marginally resectable T4, N0-1, or NX central NSCLC - N2 patients who are potentially resectable after induction chemoradiotherapy - No evidence of extrathoracic spread to liver, adrenals, brain, or bone - No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or distant metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 3 times upper limit of normal Renal - Creatinine no greater than 2.0 mg/dL Cardiovascular - No superior vena cava syndrome - No myocardial infarction within the past 6 months - No active uncontrolled congestive heart failure - No active uncontrolled arrhythmia within the past 6 months Pulmonary - FEV1 at least 800 mL Other - No other active invasive malignancy requiring therapy within the past 2 years - No ongoing need for adjuvant therapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study entry PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior pelvic or thoracic radiotherapy Surgery - See Disease Characteristics Other - Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed provided cardiac conditions are stable
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CoreyLanger, Study Chair, Fox Chase Cancer Center
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Corey Langer 215-728-2985
Additional Information:
Study ID Numbers: CDR0000256334; FCCC-02014,NCI-G02-2097
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043108
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Diagnosis and Treatment Planning in Patients Suspected of Having Lung Cancer
2. Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
3. Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer
4. Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
5. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
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