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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955175
• Other study ID #: 99-09 ICORG
• Secondary ID: ICORG-99-09EU-20
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2009
• Last updated: February 15, 2016
• Start date: November 2000

Study information

• Verified date: February 2016
• Source: ICORG- All Ireland Cooperative Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

Radiation:
• hypofractionated radiation therapy
Given 5 days a week for 20, 22, or 24 fractions

Locations

Country	Name	City	State
Ireland	Saint Luke's Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
ICORG- All Ireland Cooperative Oncology Research Group

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy		weekly during radiotherapy	Yes
Primary	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	Yes
Secondary	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	No
Secondary	Actuarial freedom from thoracic progression rate		ongoing	No