Stereotactic Precision And Conventional Radiotherapy Evaluation

NCT01920789 | Unknown

• 1 other identifier: SPACE
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small call lung cancer; Medically inoperable; Stage one; Radiotherapy; SBRT; Hypofractionation; Conventional fractionation

Outcome Measures

Primary Outcomes (1)

• Freedom from tumor progression

  complete remission,partial remission or stable disease

  At 36 months after randomization

Secondary Outcomes (1)

• Overall survival

  At 36 monts after randomization

Other Outcomes (2)

• Toxicity

  At 7 weeks, 3, 6, 12, 18, 24 and 36 months after randomization

• Quality of life

  At 7 weeks, 6 and 24 months after randomization

Study Arms (2)

Stereotactic radiotherapy

EXPERIMENTAL

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

Conventionally fractionated radiotherapy

ACTIVE COMPARATOR

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

Interventions

Stereotactic radiotherapy RADIATION

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.

Stereotactic radiotherapy

Conventionally fractionated radiotherapy RADIATION

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.

Conventionally fractionated radiotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ass. Prof. Jan Nyman: lead
• Göteborg University: collaborator
• Karolinska Institutet: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jan Nyman, Ass. Prof

  Department of Oncology, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ass. Prof. Jan Nyman

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 12, 2013
• Study Start: January 1, 2007
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 9, 2014

Record last verified: 2014-12