Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.

Phase 1

Completed

• Conditions: Inoperable Locally Advanced Non Small Cell Lung Cancer
• Interventions: Radiation: SABR; Drug: Cisplatin

• Registration Number: NCT01933568
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent chemotherapy. It is hypothesized that this will lead to an increase of local control and overall survival

Detailed Description

In locally advanced NSCLC local control has been poor, but with SABR remarkable high local control rates with low toxicity have been reported. Currently stage III and inoperable II NSCLC patients have been treated with IMRT and concurrent chemotherapy at out institute. In this study we will explore the combination of SABR and CFRT with concurrent chemotherapy

Study Timeline

• Study Start: 2013-02-28
• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-09-02
• Primary Completion: 2018-11-11
• Study Completion: 2018-11-11
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Cytological or histological proven NSCLC stage III or inoperable stage II, cT1-2a-3N1-3M0 with peripheral tumors < 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is < 5 cm).
• Weight loss < 10% in the last three months
• WHO-performance status ≤ 2
• Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine
• FEV1 and DLCO > 40 % of the age-adjusted normal value
• Minimum required laboratory data bone marrow reserve and hepatic- and renal function
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Before patient registration, written informed consent must be given according to GCP and national regulations

Exclusion criteria:

• Patients with central tumors < 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.
• Patients that receive sequential chemoradiotherapy or radiotherapy only.
• Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03)
• Patients with Pancoast tumors
• Prior radiotherapy treatment to the thorax
• Any contraindications to the administration of thoracic radiotherapy
• Pregnant women

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation	SABR	combined CFRT and SABR with concurrent cisplatin
Radiation	Cisplatin	combined CFRT and SABR with concurrent cisplatin

Primary Outcome Measures

Name	Time	Method
The mean-lung dose that is associated with a 15% probability of dose limiting toxicity, defined according to the CTCAE v4; radiation pneumonitis ≥ grade 3 and radiation induced dyspnea ≥ grade 3.	2 yrs

Trial Locations

Locations (1)

The Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands