Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lung Cancer Metastatic Lung Cancer	Radiation: Stereotactic Body Radiotherapy (SBRT)	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:

MLD [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

loco-regional control [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
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.
overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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.
Quality of life assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
valuate the increase or decrease of physical discomfort.


Estimated Enrollment:	60
Study Start Date:	October 2011
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	October 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SBRT group A escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases)	Radiation: Stereotactic Body Radiotherapy (SBRT) 3-5 fractions within 10-14 days Other Name: Stereotactic Body Radiotherapy
Experimental: SBRT group B Escalate the MLD in patients with ≥ 2 lung metastases	Radiation: Stereotactic Body Radiotherapy (SBRT) 3-5 fractions per tumor within one treatment session or sequential within one month Other Name: Stereotactic Body Radiotherapy

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543672

Contacts


Contact: Heike Peulen, MD	+31 20 512 2135	h.peulen@nki.nl
Contact: Jose Belderbos, MD, PhD	+31 20 512 2135	j.belderbos@nki.nl

Locations


United States, Michigan
Beaumont Hospital, Royal Oak	Recruiting
Royal Oak, Michigan, United States, 48076
Contact: Inga Grills, MD 248-551-7090 IGrills@beaumont.edu
Principal Investigator: Inga Grills, MD
United States, Pennsylvania
Thomas Jefferson University/ Kimmel Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, PA 19107
Contact: Maria Werner-Wasik, M.D., PhD 215-955-6000 Maria.Werner-Wasik@jeffersonhospital.org
Canada, Ontario
Prinses Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Andrew Hope, M.D., PhD Andrew.Hope@rmp.uhn.on.ca
Contact: Meredith Giuliani, M.D., PhD Meredith.Giuliani@rmp.uhn.on.ca
Germany
Universitätsklinikum Würzburg	Recruiting
Würzburg, Bayern, Germany, DE-97080
Contact: M Metz, MD, PhD +49 931-201-28984
Contact: M Metz, MD, PhD +49 931-201-28984 Metz_M2@ukw.de
Principal Investigator: M Metz, MD, PhD
Netherlands
NKI-AVL	Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Heike Peulen, MD +31 20 5122135 h.peulen@nki.nl
Contact: Jose Belderbos, MD, PhD +3 20 5122135 j.belderbos@nki.nl
Principal Investigator: Heike Peulen, MD

Sponsors and Collaborators

The Netherlands Cancer Institute

Investigators


Principal Investigator:	Heike Peulen, MD	The Netherlands Cancer Institute

More Information


Responsible Party:	The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:	NCT01543672 History of Changes
Other Study ID Numbers:	M11VOL
Study First Received:	February 21, 2012
Last Updated:	September 15, 2016
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:


lung SBRT MLD toxicity

Additional relevant MeSH terms:


Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site	Neoplasms Lung Diseases Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 23, 2016

Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously (VOLUMES)