NCT00955175

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

8.6 years

First QC Date

August 6, 2009

Last Update Submit

February 15, 2016

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

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

    weekly during radiotherapy

  • 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

Secondary Outcomes (2)

  • 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

  • Actuarial freedom from thoracic progression rate

    ongoing

Study Arms (3)

Group 1

EXPERIMENTAL

Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 24 fractions (total of 72 Gy).

Radiation: hypofractionated radiation therapy

Group 2

EXPERIMENTAL

Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 22 fractions (total of 66 Gy).

Radiation: hypofractionated radiation therapy

Group 3

EXPERIMENTAL

Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 20 fractions (total of 60 Gy).

Radiation: hypofractionated radiation therapy

Interventions

hypofractionated radiation therapyRADIATION

Given 5 days a week for 20, 22, or 24 fractions

Group 1Group 2Group 3

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Hospital

Dublin, 6, Ireland

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Pierre Thirion, MD

    Saint Luke's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2009

First Posted

August 7, 2009

Study Start

November 1, 2000

Primary Completion

June 1, 2009

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations

IE(1)