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

This study is currently recruiting participants.
Verified October 2017 by The Netherlands Cancer Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01543672
First Posted: March 5, 2012
Last Update Posted: October 27, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The Netherlands Cancer Institute
  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
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

Resource links provided by NLM:


Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

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


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


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 Completed
Royal Oak, Michigan, United States, 48076
United States, Pennsylvania
Thomas Jefferson University/ Kimmel Cancer Center Completed
Philadelphia, Pennsylvania, United States, PA 19107
Canada, Ontario
Prinses Margaret Hospital Completed
Toronto, Ontario, Canada, M5G 2M9
Germany
Universitätsklinikum Würzburg Completed
Würzburg, Bayern, Germany, DE-97080
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
First Submitted: February 21, 2012
First Posted: March 5, 2012
Last Update Posted: October 27, 2017
Last Verified: October 2017

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