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Stereotactic Precision And Conventional Radiotherapy Evaluation (SPACE)

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stereotactic radiotherapy
Conventionally fractionated radiotherapy
Sponsored by
Ass. Prof. Jan Nyman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small call lung cancer, Medically inoperable, Stage one, Radiotherapy, SBRT, Hypofractionation, Conventional fractionation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Stereotactic radiotherapy

    Conventionally fractionated radiotherapy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Freedom from tumor progression
    complete remission,partial remission or stable disease

    Secondary Outcome Measures

    Overall survival

    Full Information

    First Posted
    August 5, 2013
    Last Updated
    December 8, 2014
    Sponsor
    Ass. Prof. Jan Nyman
    Collaborators
    Göteborg University, Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01920789
    Brief Title
    Stereotactic Precision And Conventional Radiotherapy Evaluation
    Acronym
    SPACE
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    March 2015 (Anticipated)
    Study Completion Date
    March 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ass. Prof. Jan Nyman
    Collaborators
    Göteborg University, Karolinska Institutet

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-small Cell Lung Cancer
    Keywords
    Non-small call lung cancer, Medically inoperable, Stage one, Radiotherapy, SBRT, Hypofractionation, Conventional fractionation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stereotactic radiotherapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Conventionally fractionated radiotherapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Radiation
    Intervention Name(s)
    Stereotactic radiotherapy
    Intervention Description
    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.
    Intervention Type
    Radiation
    Intervention Name(s)
    Conventionally fractionated radiotherapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Freedom from tumor progression
    Description
    complete remission,partial remission or stable disease
    Time Frame
    At 36 months after randomization
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Time Frame
    At 36 monts after randomization
    Other Pre-specified Outcome Measures:
    Title
    Toxicity
    Description
    CTC version 3.0 will be used for acute and late toxicity
    Time Frame
    At 7 weeks, 3, 6, 12, 18, 24 and 36 months after randomization
    Title
    Quality of life
    Description
    EORTC QLQ 30 + LC 14 questionnaire will be used
    Time Frame
    At 7 weeks, 6 and 24 months after randomization

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jan Nyman, Ass. Prof
    Organizational Affiliation
    Department of Oncology, Sahlgrenska University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Stereotactic Precision And Conventional Radiotherapy Evaluation

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