HI-CHART:Feasibility of High-Dose Accelerated Conformal Radiotherapy

June 29, 2009 updated by: Maastricht Radiation Oncology

HI-CHART: A Phase I/II Study on the Feasibility of High-Dose Accelerated Conformal Radiotherapy in Patients With Inoperable Non-Small Cell Lung Cancer.

In this study we try to increase the radiation dose, while reducing or keeping the radiation schedule below 4 weeks.

The study hypothesis is that it is feasible to administer hyperfractionated accelerated radiotherapy to patients with inoperable or locally advanced non small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non-small cell lung cancer is still the most common cancer and the main cause of cancer death. Treatment of choice for these patients is often radiotherapy, which results in an overall 5-year survival rate between 5 and 10%. The addition of chemotherapy improves survival by a few percentages and is therefore considered standard treatment for patients with stage III disease.

However, several factors have been identified that have an impact on the local control but also on survival.

  1. There is a dose-effect relationship. A higher dose results in a better survival rate. However, higher radiation doses are currently not delivered with conventional radiation due to the tolerance of normal tissue.
  2. The time factor plays an important role in radiotherapy. Prolonging the overall treatment time decreases the outcome of radiotherapy. Radiobiological modelling of data shows that the overall treatmetn time (OTT) should be kept below 4 weeks. Results from studies support this conclusion.

So, probably the best results will be achieved when a very high radiation dose can be delivered within 4 weeks, without severally damaging normal tissue.

In order to achieve this goal, an hyperfractionated accelerated treatment regimen together with a technically very advanced radiation technique to avoid as much normal tissue as possible, will be used in this study.

Study Type

Interventional

Enrollment

180

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

  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands, 6411 PC
        • Maastircht Radiation Oncology

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

histological or cytological diagnosis of non-small cell lung cancer stage I-III disease, except supra-clavicular lymph nodes availability for participating in the detailed follow-up of the protocol able to tolerate a radiation course according to the protocol guidelines in case of previous chemotherapy, radiotherapy can start after a minimum of 3 weeks after the last CT course good performance status: Karnofsky>=70%, WHO performance status 0-2 adequate lung functions allowing the radiation according to the guidelines protocol no severe recent cardiac disease absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; conditions should be discussed with the patient before registration in the trial -

Exclusion Criteria:

patients who have a peripherally located lower lobe tumor and contralateral upper mediastinal nodes malignant pleural or pericardial effusion concurrent chemotherapy programs history of a prior malignancy excluding non melanoma skin cancer or in-situ cancer history of prior chest irradiation recent myocardial infraction uncontrolled infectious disease distant metastases (stage IV)

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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: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
acute toxicity

Secondary Outcome Measures

Outcome Measure
late toxicity

Collaborators and Investigators

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

Sponsor

Maastricht Radiation Oncology

Investigators

  • Principal Investigator: Rinus Wanders, MD, Maastricht Radiation Oncology (MAASTRO clinic)

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

December 1, 2001

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

June 30, 2009

Last Update Submitted That Met QC Criteria

June 29, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01.1314L
  • MEC MAASTRO clinic: 0105

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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