search
Back to results

Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm. (N12HYB)

Primary Purpose

Inoperable Locally Advanced Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
SABR
Cisplatin
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inoperable Locally Advanced Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • The Netherlands Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation

Arm Description

combined CFRT and SABR with concurrent cisplatin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 28, 2013
Last Updated
June 26, 2019
Sponsor
The Netherlands Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01933568
Brief Title
Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 28, 2013 (Actual)
Primary Completion Date
November 11, 2018 (Actual)
Study Completion Date
November 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inoperable Locally Advanced Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation
Arm Type
Experimental
Arm Description
combined CFRT and SABR with concurrent cisplatin
Intervention Type
Radiation
Intervention Name(s)
SABR
Intervention Description
combined CFRT and SABR with concurrent cisplatin
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
combined CFRT and SABR with concurrent cisplatin
Primary Outcome Measure Information:
Title
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.
Time Frame
2 yrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike Peulen, MD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31431387
Citation
Peulen H, Franssen G, Belderbos J, van der Bijl E, Tijhuis A, Rossi M, Sonke JJ, Damen E. SBRT combined with concurrent chemoradiation in stage III NSCLC: Feasibility study of the phase I Hybrid trial. Radiother Oncol. 2020 Jan;142:224-229. doi: 10.1016/j.radonc.2019.07.015. Epub 2019 Aug 17.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs