Risk-adapted Stereotactic Body Radiotherapy for Early Non-Small Cell Lung Cancer Using the VERO Stereotactic Body Radio Therapy System

NCT ID: NCT02224547

Last Updated: 2014-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31

Brief Summary

The purpose of this study is to perform prospective data analysis on tumor response in terms of local tumor control after 2 years, potential acute and late toxicity and survival in patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a risk-adapted approach.

Conditions

Non-Small Cell Lung Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy

For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17 Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.

Group Type: EXPERIMENTAL

Radiotherapy (Fractionated stereotactic body radiation)

Intervention Type: RADIATION

Radiation: Fractionated stereotactic body radiation therapy For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.

Interventions

Radiotherapy (Fractionated stereotactic body radiation)

Radiation: Fractionated stereotactic body radiation therapy For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology

2. Maximal tumor diameter of 6 cm

3. Only T3 lesions based upon thoracic wall involvement, only 1 lesion

4. Informed consent is required

5. Life expectancy of at least 6 months

6. Age >/= 18 y.

7. Karnofsky score ≥ 70 or ECOG score ≤ 2

8. Inoperable patients or patients refusing surgery

9. Patients with measurable lesion (according to RECIST criteria)

Exclusion Criteria

1. Diagnosis of small cell lung cancer

2. Lymph node involvement

3. Prior radiotherapy to the chest and/or mediastinum

4. No chemotherapy and/or targeted treatment within 3 months before SBRT

5. Pregnant or lactating women

6. Known allergy for CT contrast

7. No FDG-PET

8. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.

9. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Christine Collen, MD.

Radiaton Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Collen, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Brussel Radiotherapie dienst

Locations

UZ Brussel Radiotherapie dienst

Jette, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Christine Collen, MD

Role: CONTACT

christine.collen@uzbrussel.be

+324763438

Harijati Versmessen, MD

Role: CONTACT

harijati.versmessen@uzbrussel.be

+324763407

Facility Contacts

Christine Collen, MD

Role: primary

christine.collen@uzbrussel.be

+3224763438

Harijati Versmessen, MD

Role: backup

harijati.versmessen@uzbrussel.be

+3224763407

References

Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available.

Reference Type: DERIVED

PMID: 26104945 (View on PubMed)

Other Identifiers

Lung Vero SBRT

Identifier Type: -

Identifier Source: org_study_id