Individual Boosting in Non-Small Cell Lung Cancer Using Hypofractionation, Intensity-modulated Radiation Therapy and Respiratory Gating

April 5, 2016 updated by: AHS Cancer Control Alberta

A Phase I/II Dose Escalation Trial Using Hypofractionation With Individualized Differential Boosting With Respiratory Gated Intensity-modulated Radiation Therapy (IMRT) in the Treatment of Non-small Cell Lung Cancer.

Patients who have inoperable non-small cell lung cancer are presently treated with chemotherapy and radiation therapy. Despite this combined approach, the vast majority of patients will have their cancer recur after treatment. A recurrence is not curable at this time. Because of the sensitivity of surrounding structures to chest irradiation, it has not been possible to give radiation doses that can cure many of these tumors. Intensity-modulated radiation therapy is a special form of radiotherapy delivery that allows doctors to reduce the amount of radiation dose to normal tissues and therefore reduce side effects. The reduction of radiation side effects may allow more radiation to be delivered to tumors, therefore improving tumor control and possibly longevity of patients. The purpose of this study is to determine whether the combination of custom designed intensity-modulated radiotherapy (based on individual tumor anatomy) with regular chemotherapy, will be safe enough to allow further intensification of radiation treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All patients must have a satisfactory IMRT plan prior to starting radiation therapy, which will commence concurrently with chemotherapy. All patients will be treated to a minimum of 48 Gy in 20 daily fractions over 4 weeks [2.4 Gy per fraction (fx)], to the planning target volume (PTV) defined by pre chemotherapy CT with PET imaging. This is approximately biologically equivalent to a dose of 54 Gy in 27# (5 fractions/week). A differential boosting will then be selected from one of 5 dose escalation schemes. The total individual radiotherapy dose will be prescribed according to the highest dose level that can satisfy all of the set radiotherapy planning constraints for the individual's anatomy. The trial will proceed in 2 phases. In the first phase only the first 3 dose escalation schedules will be used. Once all of these 3 schedules have been deemed safe then dose levels 4 and 5 will be opened up to participation.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with histologically-proven, by biopsy or cytology, unresected lung cancer of the following histologic types: Squamous cell carcinoma, Adenocarcinoma, Undifferentiated large cell carcinoma, Non-Small cee; not otherwise specified (NOS, diagnosis on cytology alone)
  • Patients with AJCC Stage II, IIIA or IIIB if all detectable tumour can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes
  • Patient must be deemed to be suitable to undergo definitive chemo-radiotherapy by the treating Physician.
  • Age > = 18
  • ECOG/Zubrod status 0-1
  • Patients must have measurable disease on CT imaging
  • Satisfactory granulocytes, platelets, bilirubin, AST and calculated creatinine clearance
  • Dose volume constraints must be met
  • Patient must be able to use the breath-held technique

Exclusion Criteria:

  • Patients who have undergone complete or subtotal tumour resection
  • Patients with post-resection intrathoracic tumour recurrence
  • Patients eligible for definitive surgery
  • Evidence of any small cell histology
  • Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
  • Exudative pleural effusion, or pleural effusions with positive cytology. Minimal pleural effusions which are too small to safely tap (i.e. not visible on chest x-ray) are eligible.
  • Patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure and uncontrolled arrhythmias
  • Pregnant women are ineligible. Patients with childbearing potential must practice appropriate contraception
  • Patients with FEV1 <= 0.8. Patients with FEV1 >0.8 and <1.0 to be discussed with a Respiratory Physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity of treatment
Time Frame: 90 days (Acute), 5 years (Late)
90 days (Acute), 5 years (Late)

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5 years
5 years
Local control
Time Frame: 5 years
5 years
Disease Free Survival
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Investigators

  • Study Chair: Wilson Roa, MSc, MD, FRCPC, Cross Cancer Institute, Alberta Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LU-24123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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