Hypofractionated 3-Dimensional Radiation Therapy in Treating Patients With Newly Diagnosed Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer. ICORG 99-09

Cancer Trials Ireland60 enrolled

Overview

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor over a shorter period of time may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying the side effects of hypofractionated 3-dimensional radiation therapy and to see how well it works in treating patients with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.

OBJECTIVES: Primary * To evaluate the acute and long-term radio-induced toxicity (any organ) of hypofractionated 3-dimensional conformal radiotherapy in patients with newly diagnosed stage I-III non-small cell lung cancer. Secondary * To assess the radiological tumor response rate at 3 months after completion of radiotherapy. * To assess the actuarial freedom from thoracic progression rate. OUTLINE: Patients are stratified according to combined lung volume at 25 Gy (≤ 30% vs \> 30%). Patients are assigned to 1 of 3 treatment groups. * Group 1: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 24 fractions (total of 72 Gy). * Group 2: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 22 fractions (total of 66 Gy). * Group 3: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 20 fractions (total of 60 Gy). After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

hypofractionated radiation therapyRADIATION

Given 5 days a week for 20, 22, or 24 fractions

Eligibility

Sex: ALLMax age: 120 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed newly diagnosed non-small cell lung cancer meeting 1 of the following stage criteria: * Stage I or II disease * Medically inoperable or patient refused surgery * Stage IIIA or IIIB disease (no pleural effusions) * Radiation dose parameters must satisfy the required study dose-volume constraints PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Weight loss ≤ 10% within 3 months before diagnosis * No other malignancy within the past 5 years, except nonmelanoma skin cancer * No clinically significant cardiovascular disease (e.g., hypertension \[blood pressure \> 150/100 mm Hg\], myocardial infarction or stroke within the past 6 months, or unstable angina) PRIOR CONCURRENT THERAPY: * No concurrent chemotherapy

Locations (1)

Saint Luke's Hospital

Dublin, Ireland

Outcomes

Primary Outcomes

Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy

Time frame: weekly during radiotherapy

Long-term radio-induced toxicity as assessed by the long-term RTOG/EORTC and SWOG (lung) grading system every 3 months for 2 years and then every 6 months thereafter

Time frame: every 3 months for 2 years and then every 6 months thereafter

Secondary Outcomes

Tumor response rate (according to WHO response criteria) as assessed by CT scan at 3 months after completion of radiotherapy

Time frame: at 3 months after completion of radiotherapy

Actuarial freedom from thoracic progression rate

Time frame: ongoing

Data from ClinicalTrials.gov

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