Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously

Lung Cancer Clinical Trial

— VOLUMES  

Official title:

VOLUMES Treatment of Larger Tumor Volumes or ≥ 2 Lung Tumors Simultaneously in Lung Cancer Patients Using SBRT in a Mean-lung Dose Escalation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543672
• Other study ID #: M11VOL
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 22, 2011
• Est. completion date: October 31, 2017

Study information

• Verified date: October 2017
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.

Description:

A phase I/II multicenter trial will be conducted in patients with medically inoperable with peripheral non small cell lung cancer (NSCLC) > 5 cm without lymph node involvement (group A) or medically with ≥ 2 or more lung metastases (group B). Radiation pneumonitis is expected to be dose-limiting in these patients and there is evidence that the incidence is predicted by the mean lung dose (MLD). The MLD escalation will be performed separately in both patient groups, using a time-to-event continual reassessment method (TITE-CRM). All patients will receive 3-5 fractions SBRT to the lung tumor(s), with a minimum mean PTV dose ≥ 42 Gy. Fraction size may be downscaled based on the MLD constraint.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for group A and B:

• Weight loss < 10% in the last three months.

• WHO-performance status = 2

• Medical inoperable patients or patients refusing surgery.

• Chemotherapy is allowed in neoadjuvant and adjuvant setting, with exclusion of the period 4 weeks pre-SBRT and 6 weeks post-SBRT.

• Before patient registration, written informed consent must be given according to ICH/GCP, national and local regulations.

Risk group A specification:

• NSCLC (Cytological or histological proven) patients with peripheral tumors >5 cm with tumor staging cT2bN0M0 or cT3N0M0 (chest wall infiltration is no exclusion criteria, as long as the tumor diameter is > 5 cm).

• Single peripheral lung metastasis in inoperable patients with a diameter of > 5 cm. In case of first presentation of metastatic disease, cytological or histological proof is obligated.

• In patients without cytological or histological confirmation of NSCLC, a growing FDG-PET positive lesion (SUV >5) is accepted if a contra-indication for invasive diagnostic examination (or refusal) is present.

Risk group B specification:

• Patients with = 2 simultaneous peripheral lung metastases = 5 cm of any origin at any location in the lung.

• In case of first presentation of metastatic disease, cytological or histological proof is obligated. This is not necessary in case of a history of an already proven disseminated disease.

• Patients having = 2 peripheral lung metastases without unacceptable dose overlap.

Exclusion Criteria:

• Patients with central tumors

• Pancoast tumors

• Prior radiotherapy treatment to the thorax

• Patients receiving any systemic treatment during SBRT

• Pregnant patients

• Patients previously treated with adriamycin agents in case of heart involvement within the treatment field.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Metastatic Lung Cancer

Intervention

Radiation:
• Stereotactic Body Radiotherapy (SBRT)
3-5 fractions within 10-14 days
• Stereotactic Body Radiotherapy (SBRT)
3-5 fractions per tumor within one treatment session or sequential within one month

Locations

Country	Name	City	State
Canada	Prinses Margaret Hospital	Toronto	Ontario
Germany	Universitätsklinikum Würzburg	Würzburg	Bayern
Netherlands	NKI-AVL	Amsterdam
United States	Thomas Jefferson University/ Kimmel Cancer Center	Philadelphia	Pennsylvania
United States	Beaumont Hospital, Royal Oak	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MLD	The assessment of the maximum mean lung dose that can be safely treated with SBRT and that is associated with a 20% probability of the DLT.	4 years
Secondary	loco-regional control	Determine the local control and regional control as a function of the mean lung dose, the largest toxicity effects as a function of the MLD and the overall survival.	4 years
Secondary	overall survival	Determine the local control and regional control as a function of the mean lung dose, the largest toxicity effects as a function of the MLD and the overall survival.	5 years
Secondary	Quality of life assessment	valuate the increase or decrease of physical discomfort.	2 years