search
Back to results

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

Primary Purpose

Lung Cancer, Metastatic Lung Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy (SBRT)
Stereotactic Body Radiotherapy (SBRT)
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung, SBRT, MLD, toxicity

Eligibility Criteria

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

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.

Sites / Locations

  • Beaumont Hospital, Royal Oak
  • Thomas Jefferson University/ Kimmel Cancer Center
  • Prinses Margaret Hospital
  • Universitätsklinikum Würzburg
  • NKI-AVL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SBRT group A

SBRT group B

Arm Description

escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases)

Escalate the MLD in patients with ≥ 2 lung metastases

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Quality of life assessment
valuate the increase or decrease of physical discomfort.

Full Information

First Posted
February 21, 2012
Last Updated
June 26, 2019
Sponsor
The Netherlands Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01543672
Brief Title
Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 22, 2011 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Metastatic Lung Cancer
Keywords
lung, SBRT, MLD, toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBRT group A
Arm Type
Experimental
Arm Description
escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases)
Arm Title
SBRT group B
Arm Type
Experimental
Arm Description
Escalate the MLD in patients with ≥ 2 lung metastases
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy (SBRT)
Other Intervention Name(s)
Stereotactic Body Radiotherapy
Intervention Description
3-5 fractions within 10-14 days
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy (SBRT)
Other Intervention Name(s)
Stereotactic Body Radiotherapy
Intervention Description
3-5 fractions per tumor within one treatment session or sequential within one month
Primary Outcome Measure Information:
Title
MLD
Description
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
loco-regional control
Description
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.
Time Frame
4 years
Title
overall survival
Description
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.
Time Frame
5 years
Title
Quality of life assessment
Description
valuate the increase or decrease of physical discomfort.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike Peulen, MD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital, Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Facility Name
Thomas Jefferson University/ Kimmel Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
PA 19107
Country
United States
Facility Name
Prinses Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
DE-97080
Country
Germany
Facility Name
NKI-AVL
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs