|
|
Phase III Randomized Study of Neoadjuvant Cisplatin and Docetaxel With Versus Without Thoracic Conformal Radiotherapy Followed By Surgical Resection and Docetaxel in Patients With Newly Diagnosed Favorable Prognosis Stage IIIA Non-Small Cell Lung Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer
Basic Trial Information
|
Phase
|
|
|
|
Type
|
|
|
|
Status
|
|
|
|
Age
|
|
|
|
Sponsor
|
|
|
|
Protocol IDs
|
|
|
|
Phase III
|
|
|
|
Treatment
|
|
|
|
Closed
|
|
|
|
18 and over
|
|
|
|
NCI
|
|
|
|
RTOG-0412 SWOG-S0332, RTOG-0412-SWOG-S0332, CALGB-RTOG-0412, ECOG-RTOG-0412, NCCTG-RTOG-0412, NCT00113386
|
|
|
Objectives Primary - Compare overall survival of patients with newly diagnosed favorable prognosis stage IIIA non-small cell lung cancer treated with neoadjuvant cisplatin and docetaxel with vs without thoracic conformal radiotherapy followed by surgical resection and docetaxel.
Secondary - Compare median and progression-free survival of patients treated with these regimens.
- Compare clinical and pathologic response rates in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Correlate pathological complete response with disease-free and overall survival of patients treated with these regimens.
- Correlate DNA damage repair genes (ERCC1 and XRCC1), microtubule-related proteins (TUBB-III and MAP4), and shed tumor DNA with response and outcome in patients treated with these regimens.
- Correlate protein profiles, using MALDI-TOF proteomic analysis of tumor and serum, with response and prognosis in patients treated with these regimens.
- Compare quality of life of patients treated with these regimens.
- Determine the efficacy of fludeoxyglucose F 18 positron emission tomography scanning in assessing pathological response of the tumor and the mediastinal lymph nodes and in predicting long-term outcome in patients treated with these regimens.
- Correlate comorbid conditions with survival of patients treated with these regimens.
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
Biologic therapy - No prior biological agent for this cancer
- No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim during study induction therapy (for patients randomized to the chemoradiotherapy arm)
Chemotherapy - No prior systemic chemotherapy for this cancer
- Prior chemotherapy for a different cancer allowed
Endocrine therapy Radiotherapy - No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
- No routine post-operative radiotherapy
- No concurrent intensity modulated radiotherapy
Surgery - See Disease Characteristics
Other - No prior gefitinib for this cancer
- No concurrent amifostine
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count ≥ 1,800/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
Hepatic - ALT and AST ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- No hepatic insufficiency resulting in clinical jaundice or coagulation defects
Renal - Creatinine clearance ≥ 60 mL/min
Cardiovascular - No unstable angina or congestive heart failure requiring hospitalization within the past 6 months
- No transmural myocardial infarction within the past 6 months
Pulmonary - FEV1 ≥ 2.0 L
OR - Predicted post-resection FEV1 ≥ 0.8 L
- DLCO ≥ 50% of predicted
- No chronic obstructive pulmonary disease exacerbation
- No other respiratory illness requiring hospitalization or that would preclude study therapy
Immunologic - No AIDS
- No prior allergic reaction to the study drugs
- No history of severe hypersensitivity to other drugs formulated with polysorbate 80
- No acute bacterial or fungal infection requiring IV antibiotics
Other - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No unintentional weight loss > 5% of body weight within the past 6 months
- No pre-existing peripheral neuropathy ≥ grade 2
- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
- No other severe active comorbidity
Expected Enrollment 574A total of 574 patients will be accrued for this study within 4 years. Outcomes Primary Outcome(s)Comparison of overall survival
Secondary Outcome(s)Comparison of progression-free survival Comparison of median survival time Comparison of treatment toxicity rates Comparison of clinical and pathologic response rates Comparison of overall survival and progression-free survival between patients with and without pathologic complete response Association of molecular markers and overall survival, progression-free survival and response Change in patient-reported functional status
Outline This is a randomized, multicenter study. Patients are stratified according to T stage (T1 vs T2-3), number of involved mediastinal lymph nodes (1 vs 2 or more vs not evaluable), and nodal micrometastases vs clinically involved nodes (mN2 vs cN2). - Induction therapy: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV over 1 hour and docetaxel IV over 1 hour on days 1 and 22.
- Arm II: Patients undergo thoracic conformal radiotherapy once daily 5 days a week for approximately 5½ weeks (total of 28 doses). Patients also receive cisplatin IV over 1 hour on days 1, 8, 22, and 29 and docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29.
- Surgery: Within 4-8 weeks after completion of induction therapy, patients with stable disease or better undergo a lobectomy or pneumonectomy with a formal systematic mediastinal lymph node dissection.
- Consolidation therapy: Beginning 4-6 weeks after surgery, patients receive docetaxel IV over 1 hour on days 1, 22, and 43 and pegfilgrastim or filgrastim (G-CSF) subcutaneously on days 2, 23, and 44.
Quality of life is assessed at baseline, within 2 weeks after completion of induction therapy, and then at 6 and 12 months after surgery. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Trial Contact Information
Trial Lead Organizations Radiation Therapy Oncology Group | | | Maria Werner-Wasik, MD, Principal investigator | | | |
Southwest Oncology Group | | | Howard West, MD, Principal investigator | | | |
Cancer and Leukemia Group B | | | Jeffrey Crawford, MD, Protocol chair | | | |
Eastern Cooperative Oncology Group | | | Chandra Belani, MD, Protocol chair(Contact information may not be current) | | | |
North Central Cancer Treatment Group | | | James Jett, MD, Protocol chair | | | |
Registry Information | | Official Title | | Phase III Randomized Trial of Preoperative Chemotherapy Versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients With Stage IIIA (N2) Non-Small Cell Lung Cancer | | Trial Start Date | | 2005-04-08 | | Registered in ClinicalTrials.gov | | NCT00113386 | | Date Submitted to PDQ | | 2005-04-11 | | Information Last Verified | | 2006-12-14 | | NCI Grant/Contract Number | | CA21661 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
|