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

NCT00181545 | Completed Phase 1 DMC

• 2 other identifiers: P04.1338LMAASTRO 04-06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

Non-small cell lung carcinoma; radiotherapy; mean lung dose

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

• 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

Interventions

escalation of dose (radiotherapy treatment) PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

Maastircht Radiation Oncology

Heerlen, Limburg, 6411 PC, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dirk De Ruysscher, PHD

  Maastricht Radiation Oncology (MAASTRO clinic)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: December 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 30, 2009

Record last verified: 2009-06

Locations

NL (1)