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

NCT02224547 | Unknown Phase 2 DMC

• 1 other identifier: Lung Vero SBRT
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

non-small cell lung cancer; lung carcinoma; NSCLC

Outcome Measures

Primary Outcomes (1)

• Toxicity of grade 3+ as assessed by NCI CTCAE v4.0

  To monitor potential toxicity in patients with stage T1,T2,T3 N0 non-small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT)

  From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity

Secondary Outcomes (1)

• Time to local progression

  every 3 months for the first 2 years. From 3 to 5 years every 6 months. After From start of SBRT until date of death, regional fialure of last follow-up. Aanalysis occurs when all patients have been potentially followed for 24 months.

Other Outcomes (1)

• Quality of life

  baseline at inclusion, at 1 month-, 3 months- and 12 months from start SBRT

Study Arms (1)

Radiotherapy

EXPERIMENTAL

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.

Radiation: Radiotherapy (Fractionated stereotactic body radiation)

Interventions

Radiotherapy (Fractionated stereotactic body radiation) 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.

Radiotherapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
• Maximal tumor diameter of 6 cm
• Only T3 lesions based upon thoracic wall involvement, only 1 lesion
• Informed consent is required
• Life expectancy of at least 6 months
• Age \>/= 18 y.
• Karnofsky score ≥ 70 or ECOG score ≤ 2
• Inoperable patients or patients refusing surgery
• Patients with measurable lesion (according to RECIST criteria)

You may not qualify if:

• Diagnosis of small cell lung cancer
• Lymph node involvement
• Prior radiotherapy to the chest and/or mediastinum
• No chemotherapy and/or targeted treatment within 3 months before SBRT
• Pregnant or lactating women
• Known allergy for CT contrast
• No FDG-PET
• Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel Radiotherapie dienst

Jette, Brussels Capital, 1090, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 26104945 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Christine Collen, MD

  UZ Brussel Radiotherapie dienst

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Collen, MD

CONTACT

+324763438; christine.collen@uzbrussel.be

Harijati Versmessen, MD

CONTACT

+324763407; harijati.versmessen@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiaton Oncologist

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: August 25, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2017
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

BE (1)