Combined CFRT and SABR in Stage II and III NSCLC With Per... | NCT01933568

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

NCT01933568

Sponsor

The Netherlands Cancer Institute

Status

Completed

Last Update Posted

Jun 27, 2019Actual

Enrollment

15Actual

Phase

Phase 1

Conditions

Inoperable Locally Advanced Non Small Cell Lung Cancer

Interventions

SABR
Cisplatin

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2013Actual

Primary Completion Date

Nov 11, 2018Actual

Completion Date

Nov 11, 2018Actual

First Submitted Date

Aug 28, 2013

First Submission Date that Met QC Criteria

Aug 28, 2013

First Posted Date

Sep 2, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2019

Last Update Posted Date

Jun 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiation	Experimental	combined CFRT and SABR with concurrent cisplatin	Radiation: SABR Drug: Cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SABR	Radiation	combined CFRT and SABR with concurrent cisplatin	Radiation

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Heike Peulen, MD	The Netherlands Cancer Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Netherlands Cancer Institute		Amsterdam		1066 CX	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31431387	Derived	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.

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds