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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01543672
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : November 22, 2011
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. MLD [ Time Frame: 4 years ]
    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 :
  1. loco-regional control [ Time Frame: 4 years ]
    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.

  2. overall survival [ Time Frame: 5 years ]
    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.

  3. Quality of life assessment [ Time Frame: 2 years ]
    valuate the increase or decrease of physical discomfort.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543672


Locations
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United States, Michigan
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States, 48076
United States, Pennsylvania
Thomas Jefferson University/ Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, PA 19107
Canada, Ontario
Prinses Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Germany
Universitätsklinikum Würzburg
Würzburg, Bayern, Germany, DE-97080
Netherlands
NKI-AVL
Amsterdam, Netherlands, 1066 CX
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Heike Peulen, MD The Netherlands Cancer Institute
More Information
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT01543672     History of Changes
Other Study ID Numbers: M11VOL
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Netherlands Cancer Institute:
lung
SBRT
MLD
toxicity

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases