NCT00490659

Brief Summary

The purpose of this study is to test feasibility, toxicity and efficacy of two different adjuvant treatment schedules in Stage II-IIIa Non-small cell lung cancer patients with positive lymph nodes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

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

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

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

September 1, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
Last Updated

June 25, 2007

Status Verified

June 1, 2007

First QC Date

June 21, 2007

Last Update Submit

June 21, 2007

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 2-year overall survival

Secondary Outcomes (4)

  • Toxicity assessment

  • Assessment of feasibility of two treatment orders

  • Clinical and pathological response rate to neoadjuvant chemotherapy

  • Disease free survival

Interventions

gemcitabineDRUG
cisplatinDRUG
radical surgeryPROCEDURE
chemoradiotherapyPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of NSCLC (any subtype). For patients entering Arm B is also allowed to confirm histopathological diagnosis of NSCLC intraoperatively during this trial.
  • Node positive (clinically or pathologically) stage II disease or Stage IIIA: T1N1 or T2N1 or T1N2 or T2N2 or T3N1 or T3 N2, according to the revision by Mountain CF of American Joint Committee on Cancer (Mountain CF 1997, Fleming ID et al. 1997). For patient entering Arm B (with N0 stage) confirmation of N1-N2 stage must be obtained from intraoperative or post-surgery pathology report.
  • Tumor amenable to curative surgical resection.
  • Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to RECIST criteria.
  • Pathological evaluation is performed after mediastinoscopy or after surgery
  • No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, or any other type of tumor therapy).

You may not qualify if:

  • Treatment within the last 30 days with any investigational drug.
  • Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
  • Serious concomitant disorders (for example, heart failure, poorly controlled diabetes) at the investigator's discretion.
  • Presence of an uncontrolled, active infection requiring therapy (at the discretion of investigator.).
  • Stage IIIb or IV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Lublin, Poland

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

GemcitabineCisplatinChemoradiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCombined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 21, 2007

First Posted

June 25, 2007

Study Start

September 1, 2003

Study Completion

December 1, 2004

Last Updated

June 25, 2007

Record last verified: 2007-06

Locations

PL(1)