Lung Cancer Clinical Trial
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
RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin and
docetaxel may make tumor cells more sensitive to radiation therapy. Giving more than one
drug (combination chemotherapy) together with radiation therapy before surgery may shrink
the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells
that remain after surgery. It is not yet known whether giving cisplatin and docetaxel
together with radiation therapy is more effective than giving cisplatin together with
docetaxel in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying cisplatin, docetaxel, and radiation
therapy to see how well they work compared to cisplatin and docetaxel in treating patients
who are undergoing surgery for newly diagnosed stage III non-small cell lung cancer.
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.
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.
PROJECTED ACCRUAL: A total of 574 patients will be accrued for this study within 4 years.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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