Stereotactic Precision And Conventional Radiotherapy Evaluation (SPACE)

December 8, 2014 updated by: Ass. Prof. Jan Nyman

A Multicenter Randomized Phase II Study of Stereotactic Hypofractionated Radiotherapy With Body Frame Versus Conventionally Fractionated Radiotherapy for Stage I Medically Inoperable Non-small Cell Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter Scandinavian randomized phase II study of stereotactic hypofractionated radiotherapy with body frame versus conventionally fractionated radiotherapy for stage I medically inoperable non-small cell lung cancer patients. There is a 1:1 randomization between arm A: Stereotactic radiotherapy to a dose of 66 Gy with 22 Gy per fraction at the isocenter (45 Gy covers the PTV) in 3 fractions during one week with body frame fixation and a planning target volume with a 5 mm margin around the macroscopic tumour, and arm B: Conventionally fractionated radiotherapy to a dose of 70 Gy with 2 Gy per fraction in 35 fractions during 7 weeks with fixation in a vacuum pillow and a planning target volume with a 2 cm margin around the macroscopic tumour.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Non-small cell lung cancer stage I: T1-2 N0 M0.
  • Medically inoperable patients or patients refusing surgery.
  • Morphologically verified. If that is impossible there must be increased tumour size in repeated CT scans and positive PET.
  • Patients should have a life expectancy of > 6 months.
  • WHO performance status 0-2.
  • Signed written informed consent obtained.
  • Patient should be feasible for both study arms.

Exclusion Criteria:

  • Patients with central tumour growth adjacent to trachea, main bronchus or esophagus.
  • Maximal tumour diameter > 6 cm.
  • Patients with prior malignancy within the last five years (except basal cell carcinoma of the skin or in situ carcinoma of the cervix).
  • Any prior antitumoral treatment of the present lung cancer.
  • Previous irradiation that included part of the lung.
  • Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stereotactic radiotherapy
Arm A: Stereotactic radiotherapy to a dose of 66 Gy at the isocenter with 22 Gy per fraction in 3 fractions during one week with body frame fixation and a planning target volume with a 5 mm margin around the macroscopic tumour. A heterogeneous dose distribution is used so 45 Gy will cover the PTV.
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.
ACTIVE_COMPARATOR: Conventionally fractionated radiotherapy
Arm B: Conventionally fractionated radiotherapy to a dose of 70 Gy with 2 Gy per fraction in 35 fractions during 7 weeks with fixation in a vacuum pillow and a planning target volume with a 2 cm margin around the macroscopic tumour.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from tumor progression
Time Frame: At 36 months after randomization
complete remission,partial remission or stable disease
At 36 months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: At 36 monts after randomization
At 36 monts after randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity
Time Frame: At 7 weeks, 3, 6, 12, 18, 24 and 36 months after randomization
CTC version 3.0 will be used for acute and late toxicity
At 7 weeks, 3, 6, 12, 18, 24 and 36 months after randomization
Quality of life
Time Frame: At 7 weeks, 6 and 24 months after randomization
EORTC QLQ 30 + LC 14 questionnaire will be used
At 7 weeks, 6 and 24 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ass. Prof. Jan Nyman

Collaborators

Karolinska Institutet
Göteborg University

Investigators

  • Principal Investigator: Jan Nyman, Ass. Prof, Department of Oncology, Sahlgrenska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ANTICIPATED)

March 1, 2015

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

August 5, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (ESTIMATE)

August 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPACE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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