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

June 26, 2019 updated by: The Netherlands Cancer Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • The Netherlands Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiation
combined CFRT and SABR with concurrent cisplatin
Radiation: SABR
combined CFRT and SABR with concurrent cisplatin
Drug: Cisplatin
combined CFRT and SABR with concurrent cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 2 yrs
2 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Heike Peulen, MD, The Netherlands Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2013

Primary Completion (Actual)

November 11, 2018

Study Completion (Actual)

November 11, 2018

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N12HYB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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