Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00043108
Recruitment Status : Active, not recruiting
First Posted : May 7, 2003
Last Update Posted : February 26, 2018
Information provided by (Responsible Party):
Fox Chase Cancer Center

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. 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the complete resection rate and toxic death rate of patients with locally advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin.
  • Determine the survival, event-free survival, and incidence of pathologic complete remission of patients treated with this regimen.
  • Determine the protocol completion rate (CR) of patients treated with this regimen.
  • Determine the feasibility and toxicity of this regimen in these patients.
  • Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom from distant metastasis rate, and freedom from local regional failure rate of patients treated with this regimen.

OUTLINE: Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6 weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.

Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients with resectable disease undergo surgical resection within 4-8 weeks after induction therapy. Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15.

Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant treatment repeats every 4 weeks for 3 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 57 patients will be accrued for this study within 4 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting
Study Start Date : July 2002
Actual Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Maximum tolerated dose

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 3 times upper limit of normal


  • Creatinine no greater than 2.0 mg/dL


  • 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


  • FEV1 at least 800 mL


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • No prior pelvic or thoracic radiotherapy


  • See Disease Characteristics


  • Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed provided cardiac conditions are stable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00043108

United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
Principal Investigator: Aruna J. Turaka, MD Fox Chase Cancer Center

Responsible Party: Fox Chase Cancer Center Identifier: NCT00043108     History of Changes
Other Study ID Numbers: CDR0000256334
P30CA006927 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Keywords provided by Fox Chase Cancer Center:
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents