NCT01577212

Brief Summary

The aim of this present study is to test the feasibility and toxicity of individualized hypofractionated radiotherapy, and to report outcome data. In case this phase II trial has favorable results, a phase II/III trial on maximally tolerable, individualized, hypofractionated radiotherapy within a shorter overall-treatment time is aimed for.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

2.5 years

First QC Date

March 16, 2012

Last Update Submit

November 6, 2015

Conditions

Stage III Non-small Cell Lung CancerIndividualized Radiation Dose Escalation

Keywords

stage III NSCLC(chemo)radiotherapyindividualized dose-escalation

Outcome Measures

Primary Outcomes (2)

  • Pulmonary toxicity grade 2-4

    2 years

  • Esophageal toxicity grade 2-4

    2 years

Secondary Outcomes (5)

  • Increase in tumor control probability (TCP)

    2 years

  • Local-regional failure

    2 years

  • Progression-free survival

    2 years

  • Quality of life

    2 years

  • Overall survival

    2 years

Study Arms (1)

Individualized dose escalation

EXPERIMENTAL

Individualized dose escalation on the basis of the dose to the organs at risk.

Radiation: Individualized dose escalation

Interventions

Individualized dose escalationRADIATION

Individualized dose escalation on the basis of the maximally tolerable dose to organs at risk - lung, esophagus, spinal cord, heart, brachial plexus

Individualized dose escalation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed stage IIIA/B NSCLC (excluding pleural effusion and mixed pathology)
  • Irresectable disease (as assessed by multidisciplinary team) or patient refusing surgery
  • Disease which can be encompassed within a radical radiotherapy treatment plan in keeping with standard practice at the participating center
  • Proposed treatment consists of radiotherapy alone or concurrent chemoradiation
  • WHO performance status 0 or 1
  • Adequate respiratory function: FEV1 ≥ 1.5 L and DLCO \> 40%, predicted on baseline pulmonary function tests
  • Age ≥ 18 years, no upper age limit
  • Estimated life expectancy of more than 6 months
  • Patient is available for follow-up
  • Written informed consent obtained

You may not qualify if:

  • Clinically diagnosed NSCLC
  • Previous or current malignant disease likely to interfere with the protocol treatment or comparisons
  • Prior thoracic radiotherapy
  • Proposed treatment consist of sequential chemoradiation
  • Prior lobectomy / pneumonectomy
  • Prior chemotherapy using gemcitabine or bleomycine
  • Superior sulcus tumors if the brachial plexus is within the high-dose volume
  • Medically unstable (e.g., ischaemic heart disease, esophageal disorders)
  • Pregnancy
  • Connective tissue disorders
  • Abnormal kidney function interfering with administration of iv contrast agent (GFR\<60)
  • Uncontrolled diabetes mellitus hampering 18FDG-PET
  • Inability to comply with protocol or trial procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jan Bussink, MD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Esther GC Troost, MD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Robin Wijsman, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Aswin L Hoffmann, MSc

    Maastro Clinic, The Netherlands

    PRINCIPAL INVESTIGATOR

  • Lioe-Fee de Geus-Oei, MD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 16, 2012

First Posted

April 13, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 9, 2015

Record last verified: 2015-11

Locations

NL(1)