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

Phase 1
18 Years
Not Enrolling
Non-Small-Cell Lung Carcinoma

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Trial Information

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
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

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.

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,

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Dirk De Ruysscher, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maastricht Radiation Oncology (MAASTRO clinic)


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

December 2004

Completion Date:

May 2008

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Non-small cell lung carcinoma
  • radiotherapy
  • mean lung dose
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms