CompletedPhase 2NCT00043108
Official study title

Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With 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. Giving combination chemotherapy with radiation therapy before and after surgery may shrink the tumor so it can be removed during surgery and may kill any remaining tumor cells following surgery. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advanced 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 2 other study approaches.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 3, 2022 · 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?1 U.S. location

Locations may change over time.

Who runs it?Fox Chase Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Fox Chase Cancer Center
Interventions being studied
Drug: carboplatin; Drug: paclitaxel; Procedure: conventional surgery; 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.

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 or cytologically confirmed, newly diagnosed, unilateral primary non-small cell lung cancer (NSCLC)
  • Must have involvement of the superior sulcus, chest wall, or mediastinum
  • Must have at least 1 of the following:
  • Locally advanced Pancoast tumors with no documented mediastinal or supraclavicular nodal involvement (T3-T4, N0-1)
  • Resectable chest wall disease (T3, N0-1)
  • Marginally resectable T4, N0-1, or NX central NSCLC
  • N2 patients who are potentially resectable after induction chemoradiotherapy
  • No evidence of extrathoracic spread to liver, adrenals, brain, or bone
  • No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or distant metastases PATIENT CHARACTERISTICS: Age
  • 18 and over Performance status
  • Karnofsky 70-100% Life expectancy
  • Not specified Hematopoietic
  • Absolute neutrophil count at least 2,000/mm\^3
  • Platelet count at least 100,000/mm\^3 Hepatic
  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 3 times upper limit of normal Renal
  • Creatinine no greater than 2.0 mg/dL Cardiovascular
  • No superior vena cava syndrome
  • No myocardial infarction within the past 6 months
  • No active uncontrolled congestive heart failure
  • No active uncontrolled arrhythmia within the past 6 months Pulmonary
  • FEV1 at least 800 mL Other
  • No other active invasive malignancy requiring therapy within the past 2 years
  • No ongoing need for adjuvant therapy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after study entry PRIOR CONCURRENT THERAPY: Biologic therapy
  • Not specified Chemotherapy
  • Not specified Endocrine therapy
  • Not specified Radiotherapy
  • No prior pelvic or thoracic radiotherapy Surgery
  • See Disease Characteristics Other
  • Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed provided cardiac conditions are stable

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

  • Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 3, 2022. Always confirm current availability with the study team.

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