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

This study has been completed.
Sponsor:
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00181506
First received: September 13, 2005
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Non-Small-Cell Lung Carcinoma
Procedure: dose escalation (radiotherapy treatment schedule)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • acute toxicity

Secondary Outcome Measures:
  • late toxicity

Estimated Enrollment: 180
Study Start Date: December 2001
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181506

Locations
Netherlands
Maastircht Radiation Oncology
Heerlen, Limburg, Netherlands, 6411 PC
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: Rinus Wanders, MD Maastricht Radiation Oncology (MAASTRO clinic)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00181506     History of Changes
Other Study ID Numbers: P01.1314L, MEC MAASTRO clinic: 0105
Study First Received: September 13, 2005
Last Updated: June 29, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
radiotherapy
radiation dose
lung cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014