Clinical trial NCT00955175: 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
Official title: Radiation Dose Escalation For Non-Small Cell Lung Cancer Using Hypofractionated 3-Dimensional Conformal Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: 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
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2009-08-07
Enrollment: 60
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy
timeFrame: weekly during radiotherapy
measure: 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
timeFrame: 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
timeFrame: at 3 months after completion of radiotherapy
measure: Actuarial freedom from thoracic progression rate
timeFrame: ongoing
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Saint Luke's Hospital
Study officials:
affiliation: Saint Luke's Hospital
name: Pierre Thirion, MD
role: PRINCIPAL_INVESTIGATOR
References: