NCT00958321

Brief Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional conformal radiation therapy. PURPOSE: This phase II trial is studying the side effects of positron emission tomography and computed tomography and to see how well it works in planning treatment for patients undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that cannot be removed by surgery. This is a clinical study, as the patient will be treated using the PET-CT-GTV: - The pilot study is investigating the technological feasibility - The Phase II study will be a 2-stage Phase II study

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 lung-cancer

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

9.8 years

First QC Date

August 12, 2009

Last Update Submit

May 23, 2017

Conditions

Lung CancerMetastatic Cancer

Keywords

adenocarcinoma of the lunglarge cell lung cancersquamous cell lung cancermalignant pleural effusionstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IA non-small cell lung cancerstage IB non-small cell lung cancerstage IIA non-small cell lung cancerstage IIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

  • Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot)

    2016

  • Rate of loco-regional recurrence outside the PET-CT planning target volume (PTV) but within conventional 3-D PTV (Phase II)

    2016

Secondary Outcomes (2)

  • Acute and long-term radiation-induced toxicity

    2016

  • Comparison of dose delivery to organs at risk, according to planning method

    2016

Study Arms (1)

3-DCRT

EXPERIMENTAL

Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT

Procedure: computed tomographyRadiation: 3-dimensional conformal radiation therapyRadiation: fludeoxyglucose F 18Radiation: radiation therapy treatment planning/simulation

Interventions

computed tomographyPROCEDURE
3-DCRT
3-dimensional conformal radiation therapyRADIATION
3-DCRT
fludeoxyglucose F 18RADIATION
3-DCRT
radiation therapy treatment planning/simulationRADIATION
3-DCRT

Eligibility Criteria

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

You may qualify if:

  • Histologically proven (biopsy or cytology) NSCLC (SCC, Adenocarcinoma, Large Cell)
  • TNM clinical non-operable stage I/II and non-resectable stage IIIa/b without pleural effusion
  • Measurable disease
  • No other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
  • Patient suitable for radical 3-DCRT
  • ECOG-Performance status ≤ 2 / KPS \> or equal to 60
  • Weight loss \<10% within the 3 months prior to diagnosis
  • No prior radiotherapy to the thorax
  • Patient is suitable for lung-board immobilisation
  • No chemotherapy received prior to planning PET-CT scan
  • Age 18 and over
  • Provision of written informed consent

You may not qualify if:

  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
  • FEV1 \< 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Luke's Radiation Oncology Network

Dublin, 6, Ireland

Location

MeSH Terms

Conditions

Lung NeoplasmsNeoplasm MetastasisAdenocarcinoma of LungPleural Effusion, MalignantCarcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy, ConformalFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePleural NeoplasmsPleural EffusionPleural DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-AssistedRadiotherapyTherapeuticsDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Pierre Thirion, MD

    Saint Luke's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

March 1, 2007

Primary Completion

December 1, 2016

Last Updated

May 24, 2017

Record last verified: 2017-05

Locations

IE(1)