Overview

This trial is active, not recruiting.

Condition lung cancer
Treatment hypofractionated radiation therapy
Phase phase 2
Sponsor ICORG- All Ireland Cooperative Oncology Research Group
Start date November 2000
End date June 2009
Trial size 60 participants
Trial identifier NCT00955175, 99-09 ICORG, EU-20922, ICORG-99-09

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 24 fractions (total of 72 Gy).
hypofractionated radiation therapy
Given 5 days a week for 20, 22, or 24 fractions
(Experimental)
Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 22 fractions (total of 66 Gy).
hypofractionated radiation therapy
Given 5 days a week for 20, 22, or 24 fractions
(Experimental)
Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 20 fractions (total of 60 Gy).
hypofractionated radiation therapy
Given 5 days a week for 20, 22, or 24 fractions

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants up to 120 years old.

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

Additional Information

Official title Radiation Dose Escalation For Non-Small Cell Lung Cancer Using Hypofractionated 3-Dimensional Conformal Radiation Therapy
Principal investigator Pierre Thirion, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by ICORG- All Ireland Cooperative Oncology Research Group.