Clinical trial NCT01543672: Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Metastatic Lung Cancer
Keywords: lung
SBRT
MLD
toxicity
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: MLD
timeFrame: 4 years
Secondary outcomes:
measure: loco-regional control
timeFrame: 4 years
measure: overall survival
timeFrame: 5 years
measure: Quality of life assessment
timeFrame: 2 years
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital, Royal Oak
state: Michigan
city: Philadelphia
country: United States
facility: Thomas Jefferson University/ Kimmel Cancer Center
state: Pennsylvania
city: Toronto
country: Canada
facility: Prinses Margaret Hospital
state: Ontario
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Amsterdam
country: Netherlands
facility: NKI-AVL
Study officials:
affiliation: The Netherlands Cancer Institute
name: Heike Peulen, MD
role: PRINCIPAL_INVESTIGATOR
References: