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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00955175
First received: August 6, 2009
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: hypofractionated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiation Dose Escalation For Non-Small Cell Lung Cancer Using Hypofractionated 3-Dimensional Conformal Radiation Therapy

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy [ Time Frame: weekly during radiotherapy ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Actuarial freedom from thoracic progression rate [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2000
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955175

Locations
Ireland
Saint Luke's Hospital
Dublin, Ireland, 6
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
Principal Investigator: Pierre Thirion, MD Saint Luke's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT00955175     History of Changes
Other Study ID Numbers: CDR0000639199, ICORG-99-09, EU-20922
Study First Received: August 6, 2009
Last Updated: January 21, 2014
Health Authority: United States: Federal Government

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014