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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

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Radiation: Stereotactic radiotherapy Radiation: Conventionally fractionated radiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.




Primary Outcome Measures :
  1. Freedom from tumor progression [ Time Frame: At 36 months after randomization ]
    complete remission,partial remission or stable disease


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: At 36 monts after randomization ]

Other Outcome Measures:
  1. 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

  2. Quality of life [ Time Frame: At 7 weeks, 6 and 24 months after randomization ]
    EORTC QLQ 30 + LC 14 questionnaire will be used



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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920789


Sponsors and Collaborators
Ass. Prof. Jan Nyman
Göteborg University
Karolinska Institutet
Investigators
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Principal Investigator: Jan Nyman, Ass. Prof Department of Oncology, Sahlgrenska University Hospital

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Responsible Party: Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group
ClinicalTrials.gov Identifier: NCT01920789     History of Changes
Other Study ID Numbers: SPACE
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014
Keywords provided by Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group:
Non-small call lung cancer
Medically inoperable
Stage one
Radiotherapy
SBRT
Hypofractionation
Conventional fractionation
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms