Clinical trial NCT00002484: Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer
Official title: A PHASE I TRIAL OF DOSE ESCALATION OF EXTERNAL BEAM RADIATION THERAPY USING CONFORMAL 3-DIMENSIONAL TREATMENT PLANNING FOR NON-SMALL CELL LUNG CANCER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Determine the maximum dose of external beam irradiation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kenneth Rosenzweig, MD
role: STUDY_CHAIR
References:
citation: Armstrong J, Raben A, Zelefsky M, Burt M, Leibel S, Burman C, Kutcher G, Harrison L, Hahn C, Ginsberg R, Rusch V, Kris M, Fuks Z. Promising survival with three-dimensional conformal radiation therapy for non-small cell lung cancer. Radiother Oncol. 1997 Jul;44(1):17-22. doi: 10.1016/s0167-8140(97)01907-5.
citation: Armstrong J, Zelefsky M, Burt M, et al.: Acute toxicity of high dose 3-dimensional conformal radiation therapy (3-DCRT) for non small-cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-1171, 348, 1993.