NCT01066234

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
7.7 years until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

3.2 years

First QC Date

February 8, 2010

Last Update Submit

March 18, 2021

Conditions

Non-small Cell Lung Cancer

Keywords

Microscopic N2 Non-small Cell Lung CancerPaclitaxelCarboplatinCisplatin

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    36 months

Secondary Outcomes (4)

  • Overall survival (OS)

    36 months

  • Pattern of relapse

    36 months

  • Toxicity profile

    36 months

  • Quality of life (QOL)

    36 months

Study Arms (2)

concurrent chemoradiotherapy

EXPERIMENTAL
Radiation: concurrent chemoradiotherapy

chemotherapy only

ACTIVE COMPARATOR
Drug: chemotherapy only

Interventions

concurrent chemoradiotherapyRADIATION

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.

concurrent chemoradiotherapy
chemotherapy onlyDRUG

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

chemotherapy only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 28962948DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Keunchil Park, M.D., Ph.D

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 10, 2010

Study Start

October 23, 2017

Primary Completion

January 18, 2021

Study Completion

January 18, 2021

Last Updated

March 22, 2021

Record last verified: 2021-03

Locations

KR(1)