Stereotactic Precision And Conventional Radiotherapy Evaluation

Non-small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01920789
• Other study ID #: SPACE
• Status: Active, not recruiting
• Phase: N/A
• First received: August 5, 2013
• Last updated: December 8, 2014
• Start date: January 2007
• Est. completion date: March 2015

Study information

• Verified date: December 2014
• Source: Swedish Lung Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Ass. Prof. Jan Nyman	Göteborg University, Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Toxicity	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	No
Other	Quality of life	EORTC QLQ 30 + LC 14 questionnaire will be used	At 7 weeks, 6 and 24 months after randomization	No
Primary	Freedom from tumor progression	complete remission,partial remission or stable disease	At 36 months after randomization	No
Secondary	Overall survival		At 36 monts after randomization	No