Lung CancerPhase 1NCT00062335
High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
A Phase 1 study testing radiation therapy in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 7 sites in 3 countries.
Trial summary
RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Apr 2003to Feb 2006
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Medically inoperable stage I or II disease
- Stage III disease eligible provided the following are true:
- No supraclavicular node involvement
- No peripherally located lower lobe tumor AND contralateral upper mediastinal node involvement
- No distant metastasis
- No malignant pleural or pericardial effusion
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No prior myocardial infarction
- No prior complete bundle branch block
- No other prior cardiovascular disease resulting in New York Heart Association class III or IV heart disease
- No clinically significant cardiac arrhythmias
- No congestive heart failure
Pulmonary
- FEV_1 at least 1.2 L OR
- DLCO at least 60%
Other
- No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix
- No intractable or uncontrolled infection
- No psychological, familial, social, or geographical condition that would preclude study compliance and follow-up
- Able to tolerate a course of radiotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 3 weeks since prior chemotherapy
- No prior anthracyclines
- No concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the chest area
Surgery
- No prior therapeutic surgery to the chest area
Other
- No other prior therapy to the chest area
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Belgium3 sites
Institut Jules Bordet
Brussels, 1000
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, 1090
Akademisch Ziekenhuis Gent
Ghent, B-9000
France3 sites
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Institut Curie - Section Medicale
Paris, 75248
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
About this study
Official title: A Phase I Study On The Feasibility Of High Dose Three Dimensional Conformal Radiotherapy In Patients With Inoperable And Locally Advanced Non Small Cell Lung Cancer
RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage II, or stage IIIA non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the optimal dose of high-dose 3-dimensional conformal radiotherapy in patients with inoperable stage I, II, or IIIA non-small cell lung cancer who are treated according to the total lung volume irradiated.
- Determine the feasibility of this regimen, in terms of local control rates and incidence of distant metastases, in these patients.
OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. Patients are assigned to 1 of 3 strata according to the total lung volume irradiated (less than 25% vs 25-37% vs over 37%).
- Stratum I: Patients undergo high-dose 3-dimensional (3-D) conformal radiotherapy 5 days a week for 6 weeks.
- Stratum II: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-7 weeks.
- Stratum III: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-6.5 weeks.
Cohorts of 6-15 patients in each stratum receive escalating dose intensities of high-dose 3-D conformal radiotherapy (either by increasing the total dose or by shortening treatment time) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6, 2 of 15, or 3 of 30 patients experience dose-limiting toxicity.
Patients are followed at 1 month, at least every 2 months for 1 year, every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 54-135 patients (18-45 per stratum) will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- radiation therapy
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy
Secondary outcomes (2)
Late toxicity measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter
Disease progression measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startApr 2003
- Primary completionFeb 2006
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jacques Bernier, MD, PhD, Study chair, Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062335
- Sponsor's protocol ID
- EORTC-22994
- Other IDs
- EORTC-22994
- Status last verified
- Sep 2012
- First submitted
- 5 Jun 2003
- Last updated
- 24 Sep 2012
- Results posted
- No