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CompletedPhase 2NCT00006469
Official study title

Combination Chemotherapy and Radiation Therapy Followed By Surgery in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcarboplatin and paclitaxel

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 19, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Medstar Health Research Institute

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Medstar Health Research Institute
Interventions being studied
Drug: carboplatin; Drug: paclitaxel; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→Radiation therapy→Surgery→
Study topics
Before surgery (neoadjuvant)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Washington Cancer Institute at Washington Hospital CenterWashington D.C., District of Columbia
  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital CenterBaltimore, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 19, 2020. Always confirm current availability with the study team.

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