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

Inoperable Locally Advanced Non Small Cell Lung Cancer Clinical Trial

— N12HYB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933568
• Other study ID #: N12HYB
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2013
• Est. completion date: November 11, 2018

Study information

• Verified date: June 2019
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 11, 2018
• Est. primary completion date: November 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Inoperable Locally Advanced Non Small Cell Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• SABR
combined CFRT and SABR with concurrent cisplatin

Drug:
• Cisplatin
combined CFRT and SABR with concurrent cisplatin

Locations

Country	Name	City	State
Netherlands	The Netherlands Cancer Institute	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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