Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014