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Stereotactic Precision And Conventional Radiotherapy Evaluation (SPACE)

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ClinicalTrials.gov Identifier: NCT01920789
Recruitment Status : Unknown
Verified December 2014 by Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2013
Last Update Posted : December 9, 2014
Sponsor:
Collaborators:
Göteborg University
Karolinska Institutet
Information provided by (Responsible Party):
Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group

Tracking Information
First Submitted Date  ICMJE August 5, 2013
First Posted Date  ICMJE August 12, 2013
Last Update Posted Date December 9, 2014
Study Start Date  ICMJE January 2007
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
Freedom from tumor progression [ Time Frame: At 36 months after randomization ]
complete remission,partial remission or stable disease
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01920789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
Overall survival [ Time Frame: At 36 monts after randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 8, 2013)
  • 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
  • Quality of life [ Time Frame: At 7 weeks, 6 and 24 months after randomization ]
    EORTC QLQ 30 + LC 14 questionnaire will be used
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Stereotactic Precision And Conventional Radiotherapy Evaluation
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Radiation: Stereotactic radiotherapy
  • 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.
    Intervention: Radiation: Conventionally fractionated radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 8, 2013)
102
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2015
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE Not Provided
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920789
Other Study ID Numbers  ICMJE SPACE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group
Study Sponsor  ICMJE Ass. Prof. Jan Nyman
Collaborators  ICMJE
  • Göteborg University
  • Karolinska Institutet
Investigators  ICMJE
Principal Investigator: Jan Nyman, Ass. Prof Department of Oncology, Sahlgrenska University Hospital
PRS Account Swedish Lung Cancer Study Group
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP