Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer

October 31, 2013 updated by: Memorial Sloan Kettering Cancer Center

A PHASE I TRIAL OF DOSE ESCALATION OF EXTERNAL BEAM RADIATION THERAPY USING CONFORMAL 3-DIMENSIONAL TREATMENT PLANNING FOR NON-SMALL CELL LUNG CANCER

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy.

PURPOSE: Phase I trial to study the effectiveness of high-dose radiation therapy planned using a 3-dimensional picture of the tumor in treating patients who have stage I, stage II, or stage III non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum dose of external beam irradiation deliverable using conformal 3-dimensional treatment planning in patients with non-small cell lung cancer.
  • Determine the feasibility and efficacy of 3-dimensional treatment planning in delivering high doses of external beam radiotherapy to these patients.
  • Determine whether computer-generated dose-volume histograms and normal tissue complication probability models can predict the degree of pulmonary toxicity resulting from external beam radiotherapy.
  • Determine the relationship between dose of external beam radiotherapy and the degree of pulmonary function change.

OUTLINE: This is a dose escalation study.

Patients undergo 3-dimensional conformal external beam radiotherapy 5 days a week for 8-10 weeks.

Cohorts of 10 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 20% of patients experience dose-limiting toxicity.

Patients are followed at 1 month and then every 4 months thereafter.

PROJECTED ACCRUAL: A total of 60-70 patients will be accrued for this study within 3 years.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 1

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
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer

    • Clinical stage T1-4, N0-2, M0

      • Clinical stage T1-2, N0-1 must be medically inoperable
  • No distant metastases on history and physical exam, CBC, screening profile, CT or MRI of brain, CT of chest and abdomen (including adrenals and liver), and bone scan
  • No pleural effusions
  • Atelectasis not clearly distinguishable from tumor mass allowed provided all tumor and atelectasis together represent a volume that can be safely treated to the total dose delivered to gross disease
  • Diffuse pulmonary infiltrates thought to represent benign disease allowed only if representative lesion samples are proven by biopsy or cytology not to contain cancer
  • No diffuse bronchoalveolar carcinoma

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other malignancy within the past 5 years except nonmelanomatous skin cancer or noninvasive cervical carcinoma
  • No other medical illness that cannot be adequately controlled with appropriate therapy or that is considered severe enough to preclude a radical treatment approach

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for lung cancer

Chemotherapy

  • No prior chemotherapy for lung cancer

Endocrine therapy

  • No prior endocrine therapy for lung cancer

Radiotherapy

  • No prior radiotherapy for lung cancer

Surgery

  • No prior surgery for lung cancer

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: external beam radiotherapy
Patients undergo 3-dimensional conformal external beam radiotherapy 5 days a week for 8-10 weeks.
Radiation: radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the maximum dose of external beam irradiation
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Study Chair: Kenneth Rosenzweig, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 1991

Primary Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91-121
  • CDR0000077300 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-V91-0198

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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