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

Radiation Dose Escalation For Non-Small Cell Lung Cancer Using Hypofractionated 3-Dimensional Conformal Radiation Therapy

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: hypofractionated radiation therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 6
    • Saint Luke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 120 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 24 fractions (total of 72 Gy).	Radiation: hypofractionated radiation therapy; Given 5 days a week for 20, 22, or 24 fractions
Experimental: Group 2; Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 22 fractions (total of 66 Gy).	Radiation: hypofractionated radiation therapy; Given 5 days a week for 20, 22, or 24 fractions
Experimental: Group 3; Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 20 fractions (total of 60 Gy).	Radiation: hypofractionated radiation therapy; Given 5 days a week for 20, 22, or 24 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy	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	every 3 months for 2 years and then every 6 months thereafter

Secondary Outcome Measures

Outcome Measure	Time Frame
Tumor response rate (according to WHO response criteria) as assessed by CT scan at 3 months after completion of radiotherapy	at 3 months after completion of radiotherapy
Actuarial freedom from thoracic progression rate	ongoing

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland
• Investigators: Principal Investigator: Pierre Thirion, MD, Saint Luke's Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2000
• Primary Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: August 6, 2009
• First Submitted That Met QC Criteria: August 6, 2009
• First Posted (Estimate): August 7, 2009

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 15, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 99-09 ICORG; ICORG-99-09; EU-20922