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Stereotactic Precision And Conventional Radiotherapy Evaluation (SPACE)

A

Ass. Prof. Jan Nyman

Status

Unknown

Conditions

Non-small Cell Lung Cancer

Treatments

Radiation: Conventionally fractionated radiotherapy
Radiation: Stereotactic radiotherapy

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 patients

Sex

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

Stereotactic radiotherapy
Experimental group
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.
Treatment:
Radiation: Stereotactic radiotherapy
Conventionally fractionated radiotherapy
Active Comparator group
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.
Treatment:
Radiation: Conventionally fractionated radiotherapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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