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
About this trial
This is an interventional treatment trial for Inoperable Locally Advanced Non Small Cell Lung Cancer
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
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
NCT ID
NCT01933568
First Posted
August 28, 2013
Last Updated
June 26, 2019
Sponsor
The Netherlands Cancer Institute
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
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Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.
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