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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Kenneth Rosenzweig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000077300

NCT ID:

NCT00002484

Start Date:

October 1991

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021