Adjuvant CCRT vs CT in Minimal N2 NSCLC

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01066234

Collaborator

(none)

Enrollment

Location

Arms

38.9

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study propose adjuvant concurrent chemoradiotherapy vs chemotherapy alone in completely resected microscopic N2 NSCLC

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Radiation: concurrent chemoradiotherapy Drug: chemotherapy only	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Phase II Study of Adjuvant Concurrent Chemoradiotherapy vs Chemotherapy Alone in Completely Resected Microscopic N2 Non-small Cell Lung Cancer

Actual Study Start Date :

Oct 23, 2017

Actual Primary Completion Date :

Jan 18, 2021

Actual Study Completion Date :

Jan 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: concurrent chemoradiotherapy	Radiation: concurrent chemoradiotherapy 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.
Active Comparator: chemotherapy only	Drug: chemotherapy only four cycles of 3-weekly paclitaxel (175mg/m2) and carboplatin (AUC5.5).

Arm

Intervention/Treatment

Experimental: concurrent chemoradiotherapy

Radiation: concurrent chemoradiotherapy

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.

Active Comparator: chemotherapy only

Drug: chemotherapy only

four cycles of 3-weekly paclitaxel (175mg/m2) and carboplatin (AUC5.5).

Outcome Measures

Primary Outcome Measures

Disease-free survival [36 months]

Secondary Outcome Measures

Overall survival (OS) [36 months]
Pattern of relapse [36 months]
Toxicity profile [36 months]
Quality of life (QOL) [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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