Back to resultsAdjuvant CCRT vs CT in Minimal N2 NSCLC
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
concurrent chemoradiotherapy
chemotherapy only
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Microscopic N2 Non-small Cell Lung Cancer, Paclitaxel, Carboplatin, Cisplatin
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of stage IIIA(N2) NSCLC that was completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video-assisted thorascopic surgery approaches were acceptable)
- "Pathologic N2" disease (involvement of N2 nodes can only be determined at the time of surgical exploration or postoperative pathologic analysis)
- Age ≥18years
- No known residual disease (negative resection margin and no extracapsular invasion of lymph node metastasis)
- ECOG performance status of 0 to 1
- No previous chemotherapy or RT
- Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min
- Written informed consent form
Exclusion Criteria:
- Patients with preoperative mediastinoscopic N2 positive disease
- Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
- Patients with post-obstructive pneumonia or uncontrolled serious infection
- Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
- Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
concurrent chemoradiotherapy
chemotherapy only
Arm Description
Outcomes
Primary Outcome Measures
Disease-free survival
Secondary Outcome Measures
Overall survival (OS)
Pattern of relapse
Toxicity profile
Quality of life (QOL)
Full Information
NCT ID
NCT01066234
First Posted
February 8, 2010
Last Updated
March 18, 2021
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01066234
Brief Title
Adjuvant CCRT vs CT in Minimal N2 NSCLC
Official Title
A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
January 18, 2021 (Actual)
Study Completion Date
January 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC
Detailed Description
Approximately 15% of patients with non-small cell lung cancer are diagnosed with stage IIIA-N2 disease. However, this subgroup is heterogeneous, with lymph nodes that are only microscopically invaded to those that are radiologically visible with bulky ipsilateral mediastinal lymph node involvement. Surgical resection in selected patients results in 5-year survival rates of 7-24%.
The standard treatment for locally advanced clinical N2 disease is definitive concurrent chemoradiotherapy or induction chemotherapy (± radiation) followed by operation. However, in some patients, N2 status could be confirmed only after curative operation without any evidence of N2 diseases through preoperative evaluation methods (CT, PET, mediastinoscopy). We usually define those N2 disease found only after curative operation as microscopic N2, and do adjuvant chemotherapy, radiotherapy or concurrent chemoradiotherapy. However, little data about the adjuvant therapy for completely resected N2 disease have been available, Hence, we propose a randomized phase II study of adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Microscopic N2 Non-small Cell Lung Cancer, Paclitaxel, Carboplatin, Cisplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
concurrent chemoradiotherapy
Arm Type
Experimental
Arm Title
chemotherapy only
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
concurrent chemoradiotherapy
Intervention Description
weekly paclitaxel 50mg/m2 plus weekly cisplatin 25mg/m2 5times with concurrent radiotherapy (5000rad/25fx) for 5 weeks followed by 2 cycles of 3-weekly paclitaxel (175mg/m2) plus cisplatin 80mg/m2.
Intervention Type
Drug
Intervention Name(s)
chemotherapy only
Intervention Description
four cycles of 3-weekly paclitaxel (175mg/m2) and carboplatin (AUC5.5).
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
36 months
Title
Pattern of relapse
Time Frame
36 months
Title
Toxicity profile
Time Frame
36 months
Title
Quality of life (QOL)
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of stage IIIA(N2) NSCLC that was completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video-assisted thorascopic surgery approaches were acceptable)
"Pathologic N2" disease (involvement of N2 nodes can only be determined at the time of surgical exploration or postoperative pathologic analysis)
Age ≥18years
No known residual disease (negative resection margin and no extracapsular invasion of lymph node metastasis)
ECOG performance status of 0 to 1
No previous chemotherapy or RT
Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min
Written informed consent form
Exclusion Criteria:
Patients with preoperative mediastinoscopic N2 positive disease
Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
Patients with post-obstructive pneumonia or uncontrolled serious infection
Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keunchil Park, M.D., Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
28962948
Citation
Sun JM, Noh JM, Oh D, Kim HK, Lee SH, Choi YS, Pyo H, Ahn JS, Jung SH, Ahn YC, Kim J, Ahn MJ, Zo JI, Shim YM, Park K. Randomized Phase II Trial Comparing Chemoradiotherapy with Chemotherapy for Completely Resected Unsuspected N2-Positive Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Dec;12(12):1806-1813. doi: 10.1016/j.jtho.2017.09.1954. Epub 2017 Sep 28.
Results Reference
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Adjuvant CCRT vs CT in Minimal N2 NSCLC
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