Safety Study of Individualised Radiation Dose Determination for Lung Cancer Patients. - Full Text View

Sponsored by:	Maastricht Radiation Oncology
Information provided by:	Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:	NCT00181545

Purpose

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.

Condition	Intervention	Phase
Non-Small-Cell Lung Carcinoma	Procedure: escalation of dose (radiotherapy treatment)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	Individualised Radiation Dose Determination on Basis of Normal Tissue Dose Constraints in Patients With Non-Small-Cell Lung Cancer: A Phase I Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Pneumonia Radiation Therapy

U.S. FDA Resources

Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	December 2004
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181545

Locations

Netherlands, Limburg
Maastircht Radiation Oncology
HEERLEN, Limburg, Netherlands, 6411 PC

Sponsors and Collaborators

Maastricht Radiation Oncology

Investigators

Principal Investigator:

Dirk De Ruysscher, PHD

Maastricht Radiation Oncology (MAASTRO clinic)

More Information

No publications provided

Study ID Numbers:	P04.1338L, MAASTRO 04-06
Study First Received:	September 13, 2005
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00181545 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:

Non-small cell lung carcinoma
radiotherapy
mean lung dose

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on July 06, 2009