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Therapeutic Areas: Oncology | Pulmonary/Respiratory Diseases | Family Medicine
Disease Category: Lung Cancer
Location: United States, IL
Clinical Trial Details
Research Study Summary
ECOG E1505 A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) -IIIA Non-Small Cell Lung Cancer (NSCLC)
This research is being done because even with the most aggressive after-surgery treatment with chemotherapy, many people still have the lung cancer recur (come back).
The purpose of this study is to determine if adding the new drug bevacizumab to chemotherapy improves the chance for cure for patients who have had surgery for the removal of the lung cancer. We will compare the effects (good and bad) of adding bevacizumab to chemotherapy with standard chemotherapy alone on you and your lung cancer to see which is better at preventing the cancer from coming back. Bevacizumab is investigational, which means it has not been approved by the FDA for use in this cancer.
All patients will receive what is felt to be a standard form of chemotherapy to be given as an outpatient. Only the combination of cisplatin and vinorelbine in patients with early stage lung cancer who have had the cancer removed (adjuvant chemotherapy) has been shown to improve survival when given every 28 days. The other 3 chemotherapy regimens in this study (cisplatin and docetaxel vs. cisplatin and pemetrexed vs. cisplatin and gemcitabine) have not been tested as adjuvant chemotherapy. They are, however, proven to be as active (or perhaps even more active) than the combination of cisplatin and vinorelbine for patients who have metastatic lung cancer (lung cancer that has spread to other parts of the body). It is therefore felt by most doctors that they will work just as well as cisplatin and vinorelbine as adjuvant chemotherapy and that is why they are options in this trial.
Patient Inclusion Criteria:
- In order to be eligible for this trial, patients must have undergone complete resection of their non-small cell lung cancer (NSCLC) [stage IB (> 4 cm)] - [IIIA (T2-3N0, T1-3N1, T1-3N2] prior to enrollment. (Refer to Appendix X for staging guidelines per AJCC 6th edition). Accepted types of resection will consist of lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy. Resections by segmentectomy or wedge resection will not be accepted. Mediastinal lymph node sampling at specified levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors)
- Age > 18 years
- ECOG performance status 0 or 1
Patient Exclusion Criteria:
- Patients must not have received the following:
- Prior systemic chemotherapy at any time.
- Methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 2 weeks prior to date of registration will be allowed.
- Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required.
To Learn more
Both Male and Female
Date Last Changed:
July 17, 2013
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