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


Phase 2
N/A
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy

Outcome Time Frame:

weekly during radiotherapy

Safety Issue:

Yes

Principal Investigator

Pierre Thirion, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Luke's Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000639199

NCT ID:

NCT00955175

Start Date:

November 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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