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

Combined Stereotactic Radiotherapy and Conventional Fractionation in Stage II and III Non Small Cell Lung Cancer (NSCLC) With Peripheral Tumors Smaller Than 5 cm

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01933568

Acronym

N12HYB

Enrollment

Registered

2013-09-02

Start date

2013-02-28

Completion date

2018-11-11

Last updated

2019-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inoperable Locally Advanced Non Small Cell Lung Cancer

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

Interventions

RADIATIONSABR

combined CFRT and SABR with concurrent cisplatin

DRUGCisplatin

combined CFRT and SABR with concurrent cisplatin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026