ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Radiation Therapy Followed by Atezolizumab in Stage II or III Non-small Cell Lung Cancer Patients

NCT04310020

Lung Non-Small Cell Carcinoma Stage II Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8

RECRUITING PHASE2

Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy

NCT04351256

NSCLC, Stage III

ACTIVE_NOT_RECRUITING PHASE2

Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer

NCT03035890

Non Small Cell Lung Cancer Metastatic

COMPLETED NA

Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

NCT04210492

Non-small Cell Lung Cancer

RECRUITING PHASE1/PHASE2

Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors

NCT07261631

Pancreatic Ductal Adenocarcinoma Non-Small Cell Lung Cancer HR+/HER2- Ductal and Lobular Breast Cancer +3 more

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used due to the two-stage sampling; the method of Conover will be used for tumor response.

To estimate tumor response rates of this treatment regimen and identify the most effective RT dose level, defined as the level associated with the best response rate. Estimates of tumor response rates will be presented with corresponding confidence intervals using the exact method of Conover. Survival will be estimated by the Kaplan-Meier method.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Carcinoma (NSCLC)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Iressa and RT

Iressa plus thoracic RT at the following dose levels:

* Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
* Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
* Level 3: 63.0 Gy in 15 fractions of 4.2 Gy

Group Type EXPERIMENTAL

ZD1839 (Iressa)

Intervention Type DRUG

Thoracic Radiotherapy

Intervention Type RADIATION

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ZD1839 (Iressa)

Intervention Type DRUG

Thoracic Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically confirmed non small cell lung cancer
* Stage IV needing radiation therapy to control symptoms
* Patients with brain metastases
* Unresectable or medically inoperable

Exclusion Criteria

* Small cell lung cancer
* Previous thoracic radiation therapy
* Oxygen-dependent patients
* Forced expiratory volume in 1 second (FEV1) less than 1.5
* Patients with active interstitial lung disease
* Patients with underlying lung disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No