VOLUMES Treatment of Larger Tumor Volumes or 2 Lung Metastases Simultaneously in Lung Cancer Patients Using SBRT in a Mean-lung Dose Escalation Study
18 Years
N/A
Both
Lung Cancer, Metastatic Lung Cancer
Trial Information
VOLUMES Treatment of Larger Tumor Volumes or 2 Lung Metastases Simultaneously in Lung Cancer Patients Using SBRT in a Mean-lung Dose Escalation Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MLD
Outcome 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.
Outcome Time Frame:
4 years
Safety Issue:
Yes
Principal Investigator
Heike Peulen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Netherlands Cancer Institute
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
M11VOL
NCT ID:
NCT01543672
Start Date:
October 2011
Completion Date:
August 2015
Related Keywords:
- Lung Cancer
- Metastatic Lung Cancer
- lung
- SBRT
- MLD
- toxicity
- Lung Neoplasms
- Neoplasm Metastasis
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