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

January 5, 2022 updated by: Fox Chase Cancer Center

Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)
Drug: carboplatin
Radiation: radiation therapy
Procedure: conventional surgery
Drug: paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxic Death Rate
Time Frame: 5 years
5 years
Complete Resection Rates
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 5 years
5 years
Event-free Survival
Time Frame: 5 years
5 years
Pathologic Complete Remission (pCR)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Aruna J. Turaka, MD, Fox Chase Cancer Center
  • Principal Investigator: Mark Hallman, MD, Fox Chase Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

August 5, 2002

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000256334
  • P30CA006927 (U.S. NIH Grant/Contract)
  • NCI-G02-2097 (Other Identifier: National Cancer Institutes)
  • 02-014 (Other Identifier: FCCC IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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