Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113386
Status:
TERMINATED
Last Update Posted:
2013-06-28
First Post:
2005-06-07
Brief 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
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study terminated early due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCCTG-RTOG-0412 | None | None | None |
| CDR0000429479 | None | None | None |
| SWOG-S0332 | None | None | None |
| CALGB-RTOG-0412 | None | None | None |
| ECOG-RTOG-0412 | None | None | None |