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

This study is currently recruiting participants.
Verified February 2012 by The Netherlands Cancer Institute
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT01543672
First received: February 21, 2012
Last updated: March 2, 2012
Last verified: February 2012
History of Changes
  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 Metastases Simultaneously in Lung Cancer Patients Using SBRT in a Mean-lung Dose Escalation Study

Resource links provided by NLM:

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: August 2015
Estimated Primary Completion Date: August 2015 (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 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
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 two 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.
  • FEV1 and DLCO less than 40 % of the age-adjusted normal value
  Contacts and Locations
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
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

No publications provided

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: March 2, 2012
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
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013