NCT00128037

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 1999

Longer than P75 for phase_2

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

Study Start

First participant enrolled

May 1, 1999

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

First QC Date

August 8, 2005

Last Update Submit

September 20, 2016

Conditions

Pulmonary Neoplasm

Keywords

pulmonary neoplasmpreoperative chemoradiotherapysurgical resectionsuperior sulcus tumorchest wall invasionmytomicin Cvindesinecisplatin

Outcome Measures

Primary Outcomes (1)

  • 3-year survival rate

Secondary Outcomes (3)

  • complete resection rate

  • post-surgical morbidity/mortality

  • local control rate

Interventions

mitomycin C, vindesine, cisplatin and radiotherapyDRUG

Eligibility Criteria

Age15 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed, pathologically documented non-small cell lung cancer (NSCLC)
  • Invasion to the first rib or more superior chest wall
  • Age: 15-74 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Ample organ function
  • No prior chemo- or radiotherapy
  • Signed informed consent

You may not qualify if:

  • Metastasis to, or involvement of, mediastinal node (N2)
  • Distant metastasis or dissemination to pleura/pericardium
  • Active concomitant malignancy
  • Unstable angina, recent myocardial infarction, heart failure
  • Uncontrolled diabetes or hypertension
  • Pregnant or lactating women
  • Other severe complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Chuo-ku, Tokyo, 104-0045, Japan

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsPancoast Syndrome

Interventions

MitomycinVindesineCisplatinRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolizidinesIndolizinesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Study Officials

  • Harubumi Kato, M.D., Ph.D.

    Tokyo Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

May 1, 1999

Study Completion

February 1, 2006

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

JP(1)