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

Primary Purpose

Non-Small Cell Lung Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Radiotherapy (Fractionated stereotactic body radiation)

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Carcinoma focused on measuring non-small cell lung cancer, lung carcinoma, NSCLC

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Sites / Locations

UZ Brussel Radiotherapie dienstRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Time to local progression

Overall survival, local progression free survival, disease free survival, time from start of SBRT to death, local, regional or disseminated recurrence.

Full Information

NCT ID

NCT02224547

First Posted

May 27, 2014

Last Updated

September 8, 2014

Sponsor

Universitair Ziekenhuis Brussel

1. Study Identification

Unique Protocol Identification Number

NCT02224547

Brief Title

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

Official Title

Phase II Protocol for Risk-adapted Stereotactic Body Radio Therapy for Stage T1-T3N0 Non-Small Cell Lung Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Carcinoma

Keywords

non-small cell lung cancer, lung carcinoma, NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy (Fractionated stereotactic body radiation)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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)

Time Frame

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

Secondary Outcome Measure Information:

Title

Time to local progression

Description

Overall survival, local progression free survival, disease free survival, time from start of SBRT to death, local, regional or disseminated recurrence.

Time Frame

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 Pre-specified Outcome Measures:

Title

Quality of life

Description

Quality of life

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christine Collen, MD

Phone

+324763438

christine.collen@uzbrussel.be

First Name & Middle Initial & Last Name or Official Title & Degree

Harijati Versmessen, MD

Phone

+324763407

harijati.versmessen@uzbrussel.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine Collen, MD

Organizational Affiliation

UZ Brussel Radiotherapie dienst

Official's Role

Principal Investigator

Facility Information:

Facility Name

UZ Brussel Radiotherapie dienst

City

Jette

State/Province

Brussels

ZIP/Postal Code

1090

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine Collen, MD

Phone

+3224763438

christine.collen@uzbrussel.be

First Name & Middle Initial & Last Name & Degree

Harijati Versmessen, MD

Phone

+3224763407

harijati.versmessen@uzbrussel.be

First Name & Middle Initial & Last Name & Degree

Christine Collen, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

26104945

Citation

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.

Results Reference

derived

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

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