NCT00006469

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 these treatments before surgery may kill more tumor cells in patients with non-small cell lung cancer. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy before surgery in treating patients who have stage IIB non-small cell lung cancer or stage IIIA non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Timeline
Completed

Started Aug 1999

Typical duration for phase_2 lung-cancer

Geographic Reach
1 country

2 active sites

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

August 1, 1999

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2000

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2006

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

6.5 years

First QC Date

November 6, 2000

Last Update Submit

August 17, 2020

Conditions

Lung Cancer

Keywords

stage II non-small cell lung cancerstage IIIA non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

  • Pathologic response rate

    as measured by pathology of the resected specimen and chest x-ray at 3 and 5 years after completion of study treatment.

    3-5 Years

  • Disease-free and overall survival at 3 and 5 years after completion of study treatment

    3-5 Years

Study Arms (1)

Single arm study

OTHER

Concurrent Paclitaxel, Carboplatin, and External-Beam Radiation Followed by Surgical Resection in Locally Advanced Non-Small-Cell Lung Cancer

Drug: carboplatinDrug: paclitaxelProcedure: conventional surgeryProcedure: neoadjuvant therapyRadiation: radiation therapy

Interventions

carboplatinDRUG
Also known as: paraplatin
Single arm study
paclitaxelDRUG
Also known as: taxol
Single arm study
conventional surgeryPROCEDURE
Single arm study
neoadjuvant therapyPROCEDURE
Single arm study
radiation therapyRADIATION
Single arm study

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed bulky stage IIB or stage IIIA non-small cell lung cancer * Ipsilateral mediastinal node involvement by mediastinoscopy * No contralateral lymph node involvement * No malignant pleural effusion * No distant metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * ALT/AST less than 2 times upper limit of normal * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine no greater than 2.0 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (2)

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CarboplatinPaclitaxelNeoadjuvant TherapyRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesCombined Modality TherapyTherapeutics

Study Officials

  • David J. Perry, MD

    Medstar Health Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Concurrent Paclitaxel, Carboplatin, and External-Beam Radiation Followed by Surgical Resection in Locally Advanced Non-Small-Cell Lung Cancer
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2000

First Posted

January 27, 2003

Study Start

August 1, 1999

Primary Completion

January 30, 2006

Study Completion

January 30, 2006

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations

US(2)