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

NCT00181506 | Completed Phase 1

• 2 other identifiers: P01.1314LMEC MAASTRO clinic: 0105
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

radiotherapy; radiation dose; lung cancer

Outcome Measures

Primary Outcomes (1)

• acute toxicity

Secondary Outcomes (1)

• late toxicity

Interventions

dose escalation (radiotherapy treatment schedule) PROCEDURE

Eligibility Criteria

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

You may qualify if:

• 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 -

You may not qualify if:

• 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)

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; Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Rinus Wanders, MD

  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, 2001
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 30, 2009

Record last verified: 2009-06

Locations

NL (1)