Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously

Phase 1

Completed

• Conditions: Lung Cancer; Metastatic Lung Cancer
• Interventions: Radiation: Stereotactic Body Radiotherapy (SBRT)

• Registration Number: NCT01543672
• Lead Sponsor: The Netherlands Cancer Institute

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.

Study Timeline

• Study Start: 2011-11-22
• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Status Verified: 2017-10
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SBRT group A	Stereotactic Body Radiotherapy (SBRT)	escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases)
SBRT group B	Stereotactic Body Radiotherapy (SBRT)	Escalate the MLD in patients with ≥ 2 lung metastases

Primary Outcome Measures

Name	Time	Method
MLD	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

Name	Time	Method
loco-regional control	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.
Quality of life assessment	2 years	valuate the increase or decrease of physical discomfort.
overall survival	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.

Trial Locations

Locations (5)

Thomas Jefferson University/ Kimmel Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Prinses Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Beaumont Hospital, Royal Oak; 🇺🇸 Royal Oak, Michigan, United States

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Bayern, Germany

NKI-AVL; 🇳🇱 Amsterdam, Netherlands