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Stereotactic Precision And Conventional Radiotherapy Evaluation

NCT01920789 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2014-12-09

No results posted yet for this study

Summary

A randomized phase II study for medically inoperable stage I non-small cell lung cancer where stereotactic body radiotherapy in three fractions to 66 Gy is compared with conventionally fractionated radiotherapy to 70 Gy in 35 fractions.

Conditions

Interventions

RADIATION

Stereotactic radiotherapy

Margin between CTV and PTV of 5 mm in transversal direction (except for small targets (\<3cm) not fixed to thoracic wall or mediastinal structures, where margin should be 10 mm) and 10 mm in longitudinal direction. Planned heterogeneous dose distribution within the PTV with about 50% higher dose to the center compared to the periphery. Hypofractionation with 22 Gy times 3 at the isocenter (15 Gy at the periphery of the PTV)during one week will be used.

RADIATION

Conventionally fractionated radiotherapy

Clinical target volume (CTV) comprises the Gross Tumor Volume (GTV), including its diffuse growth at the borders. Planning target volume (PTV) is defined as the CTV with a total margin of 2 cm in all directions. The patient will receive 35 fractions, with a dose of 2.0 Gy/fraction at the ICRU reference point to a total dose of 70 Gy. The treatments will be given five days a week. The total treatment time should be as close to seven weeks as possible. The aim is that the dose distribution should be as homogeneous as possible.

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Ass. Prof. Jan Nyman

    lead NETWORK

Principal Investigators

  • Jan Nyman, Ass. Prof · Department of Oncology, Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01920789 on ClinicalTrials.gov