Adjuvant CCRT vs CT in Minimal N2 NSCLC

NCT ID: NCT01066234

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2021-01-18

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

concurrent chemoradiotherapy

Group Type: EXPERIMENTAL

concurrent chemoradiotherapy

Intervention Type: RADIATION

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.

chemotherapy only

Group Type: ACTIVE_COMPARATOR

chemotherapy only

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: RADIATION

chemotherapy only

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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)

2. "Pathologic N2" disease (involvement of N2 nodes can only be determined at the time of surgical exploration or postoperative pathologic analysis)

3. Age ≥18years

4. No known residual disease (negative resection margin and no extracapsular invasion of lymph node metastasis)

5. ECOG performance status of 0 to 1

6. No previous chemotherapy or RT

7. 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

8. Written informed consent form

Exclusion Criteria

1. Patients with preoperative mediastinoscopic N2 positive disease

2. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia

3. Patients with post-obstructive pneumonia or uncontrolled serious infection

4. Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)

5. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Keunchil Park

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keunchil Park, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 28962948 (View on PubMed)

Other Identifiers

2009-04-004

Identifier Type: -

Identifier Source: org_study_id