Safety Study of Individualised Radiation Dose Determination for Lung Cancer Patients.

June 29, 2009 updated by: Maastricht Radiation Oncology

Individualised Radiation Dose Determination on Basis of Normal Tissue Dose Constraints in Patients With Non-Small-Cell Lung Cancer: A Phase I Study

Radiotherapy is treatment of choice for inoperable lung cancer. Research has shown that the local control rate is low and the radiation often causes pneumonitis and/or esophagitis.

To predict to lung damage the mean lung dose can be calculated. This allows us to give a higher total dose to the tumor and to improve the local control rate.

Study hypothesis: It will be safe to administer a radiation dose as high as possible to the tumor, taking into account the mean lung dose, calculated by the treatment planning system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Radiotherapy is treatment of choice for inoperable lung cancer. Research has shown that the survival rate as well as the local control rate is low. If chemotherapy treatment is added it leads to a slightly better outcome. The radiotherapy treatment often causes pneumonitis and/or esophagitis. So damage to the normal tissue restricts the radiation dose that can be administered.

However, several studies have shown that higher doses lead to better local control. Furthermore it is evident that the radiotherapy treatment should be given in a short time, preferably the treatment time should not exceed 32 days.

To avoid a higher toxicity the normal tissue has to be spared, but to increase the local control rate the tumor dose must be as high as possible. This dilemma can only be solved by using very sophisticated treatment planning techniques in combination with a biologically superior treatment schedule. This schedule consists of delivering radiation dose twice a day instead of once, thus keeping the overall treatment time as low as possible.

For the whole patient population, the mean lung dose can to a great extend predict the probability for developing radiation pneumonitis and the post-radiotherapy lung function. A logical next step is to determine the dose of radiotherapy on an individualised calculation of the maximum tolerated dose, being defined as the mean lung dose and the spinal cord dose.

The objective of this trial is to investigate whether individualised radiation dose calculation based on a mean lung dose and the constraints of the spinal cord, in combination with an overall treatment time of less than 32 days, and only irradiating the primary tumor and the PET scan positive mediastinal areas is safe.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • 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:

  • Histologically proven non-small cell lung cancer
  • UICC stage I-III
  • WHO performance status 0-2
  • Less than 10 % weight loss the last 6 months
  • In case of previous chemotherapy, radiotherapy can start after a minimum of 21 days after the last chemotherapy course
  • Reasonable lung function: FEV1 ³ 60 % of the predicted value
  • No recent ( < 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
  • No active peptic oesophagitis
  • Life expectancy more than 6 months
  • Measurable cancer
  • Willing and able to comply with the study prescriptions
  • 18 years or older
  • Not pregnant and willing to take adequate contraceptive measures during the study
  • Have given written informed consent before patient registration
  • No previous radiotherapy to the chest

Exclusion Criteria:

  • Not non-small cell histology, e.g. mesothelioma, lymphoma
  • Mixed pathology, e.g. non-small cell plus small cell cancer
  • Malignant pleural or pericardial effusion
  • Concurrent chemotherapy with radiation
  • History of prior chest radiotherapy
  • Recent ( < 3 months) myocardial infarction
  • Uncontrolled infectious disease
  • Distant metastases (stage IV)
  • Patients with active peptic oesophagitis in the last year.
  • Less than 18 years old
  • Pregnant or not willing to take adequate contraceptive measures during the study

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
incidence of steroid dependent (grade 2 or more) radiation pneumonitis 6 months after the last radiotherapy dose.

Secondary Outcome Measures

Outcome Measure
quality of life
acute esophagitis
incidence of radiation pneumonitis according to the location of the primary tumour
FEV1 6 months after radiotherapy
DLCO 6 months after radiotherapy
late esophagitis, 6 months after radiotherapy
tumor response, 70 days post chest radiotherapy

Collaborators and Investigators

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

Sponsor

Maastricht Radiation Oncology

Investigators

  • Principal Investigator: Dirk De Ruysscher, PHD, 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, 2004

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

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

  • P04.1338L
  • MAASTRO 04-06

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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