NCT01543672

Brief Summary

Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P75+ for phase_1 lung-cancer

Timeline
Completed

Started Nov 2011

Typical duration for phase_1 lung-cancer

Geographic Reach
4 countries

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

June 27, 2019

Status Verified

October 1, 2017

Enrollment Period

5.9 years

First QC Date

February 21, 2012

Last Update Submit

June 26, 2019

Conditions

Lung CancerMetastatic Lung Cancer

Keywords

lungSBRTMLDtoxicity

Outcome Measures

Primary Outcomes (1)

  • MLD

    The assessment of the maximum mean lung dose that can be safely treated with SBRT and that is associated with a 20% probability of the DLT.

    4 years

Secondary Outcomes (3)

  • loco-regional control

    4 years

  • overall survival

    5 years

  • Quality of life assessment

    2 years

Study Arms (2)

SBRT group A

EXPERIMENTAL

escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases)

Radiation: Stereotactic Body Radiotherapy (SBRT)

SBRT group B

EXPERIMENTAL

Escalate the MLD in patients with ≥ 2 lung metastases

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Stereotactic Body Radiotherapy (SBRT)RADIATION

3-5 fractions within 10-14 days

Also known as: Stereotactic Body Radiotherapy
SBRT group A

Eligibility Criteria

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

You may qualify if:

  • Weight loss \< 10% in the last three months.
  • WHO-performance status ≤ 2
  • Medical inoperable patients or patients refusing surgery.
  • Before patient registration, written informed consent must be given according to ICH/GCP, national and local regulations.
  • Risk group A specification:

You may not qualify if:

  • Single peripheral lung metastasis in inoperable patients with a diameter of \> 5 cm. In case of first presentation of metastatic disease, cytological or histological proof is obligated.
  • In patients without cytological or histological confirmation of NSCLC, a growing FDG-PET positive lesion (SUV \>5) is accepted if a contra-indication for invasive diagnostic examination (or refusal) is present.
  • Risk group B specification:
  • Patients with ≥ 2 simultaneous peripheral lung metastases ≤ 5 cm of any origin at any location in the lung.
  • In case of first presentation of metastatic disease, cytological or histological proof is obligated. This is not necessary in case of a history of an already proven disseminated disease.
  • Patients having ≥ 2 peripheral lung metastases without unacceptable dose overlap.
  • Patients with central tumors
  • Pancoast tumors
  • Prior radiotherapy treatment to the thorax
  • Patients receiving any systemic treatment during SBRT
  • Pregnant patients
  • Patients previously treated with adriamycin agents in case of heart involvement within the treatment field.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, 48076, United States

Location

Thomas Jefferson University/ Kimmel Cancer Center

Philadelphia, Pennsylvania, PA 19107, United States

Location

Prinses Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Universitätsklinikum Würzburg

Würzburg, Bavaria, DE-97080, Germany

Location

NKI-AVL

Amsterdam, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Heike Peulen, MD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2012

First Posted

March 5, 2012

Study Start

November 22, 2011

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

June 27, 2019

Record last verified: 2017-10

Locations

CA(1)NL(1)DE(1)US(2)