NCT00003202

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to compare the effectiveness of gemcitabine with radiation therapy alone or following two-drug combination chemotherapy in treating patients with stage III non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 lung-cancer

Timeline
Completed

Started Jan 1998

Longer than P75 for phase_1 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

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

November 26, 2003

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

4.2 years

First QC Date

November 1, 1999

Last Update Submit

August 8, 2018

Conditions

Lung Cancer

Keywords

squamous cell lung cancerlarge cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung canceradenocarcinoma of the lungadenosquamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • •Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy

    6 weeks

Secondary Outcomes (1)

  • assess the efficacy of dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy

    72 days

Interventions

cisplatinDRUG
gemcitabine hydrochlorideDRUG
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed stage IIIA or IIIB non-small cell lung cancer that is unicentric and inoperable, including the following cellular types: * Squamous cell carcinoma * Adenocarcinoma * Bronchoalveolar carcinoma * Large cell anaplastic carcinoma * Non-small cell lung cancer not otherwise specified * Tumors may be multifocal if all of disease is believed to be result of direct spread * Disease must be fully accessible by radiotherapy ports for the entire prescribed dose * No supraclavicular nodes or diffuse pleural involvement * No contralateral hilar disease or an exudative, bloody, or cytologically malignant effusion * Measurable disease required for phase II of this study PATIENT CHARACTERISTICS: Age: * Any age Performance status: * ECOG 0-2 Life expectancy: * At least 1 year Hematopoietic: * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin greater than 10 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * BUN no greater than 1.5 times normal * Creatinine no greater than 1.5 times normal Pulmonary: * FEV1 no greater than 1 liter except if tumor has negatively impacted * pulmonary function Other: * No other serious medical or psychiatric illness * No prior lung cancer except if free of disease for more than 3 years * No other prior malignancy except nonmelanoma skin cancer or if free of * disease for more than 1 year * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior thoracic radiotherapy * Concurrent radiotherapy to other anatomic sites allowed Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Interventions

CisplatinGemcitabineRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTherapeutics

Study Officials

  • Arthur William Blackstock, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

November 26, 2003

Study Start

January 1, 1998

Primary Completion

April 1, 2002

Study Completion

July 1, 2006

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(1)