NCT00002484

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P75+ for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1991

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

16.8 years

First QC Date

November 1, 1999

Last Update Submit

October 31, 2013

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Determine the maximum dose of external beam irradiation

    2 years

Study Arms (1)

external beam radiotherapy

EXPERIMENTAL

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

Radiation: radiation therapy

Interventions

radiation therapyRADIATION
external beam radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (2)

  • 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.

    PMID: 9288852RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Kenneth Rosenzweig, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

October 1, 1991

Primary Completion

July 1, 2008

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

US(1)