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Positron Emission Tomography and Computed Tomography in Planning Treatment for Patients Undergoing 3-Dimensional Conformal Radiation Therapy for Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery. ICORG 06-35

Primary Purpose

Lung Cancer, Metastatic Cancer

Status

Terminated

Phase

Phase 2

Locations

Ireland

Study Type

Interventional

Intervention

computed tomography

3-dimensional conformal radiation therapy

fludeoxyglucose F 18

radiation therapy treatment planning/simulation

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, malignant pleural effusion, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

St Luke's Radiation Oncology Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3-DCRT

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Acute and long-term radiation-induced toxicity

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

Full Information

NCT ID

NCT00958321

First Posted

August 12, 2009

Last Updated

May 23, 2017

Sponsor

Cancer Trials Ireland

1. Study Identification

Unique Protocol Identification Number

NCT00958321

Brief Title

Positron Emission Tomography and Computed Tomography in Planning Treatment for Patients Undergoing 3-Dimensional Conformal Radiation Therapy for Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery. ICORG 06-35

Official Title

Prospective Evaluation of PET-CT Scan in Patients With Non-operable or Non-resectable NSCLC Treated by Radical 3-Dimensional Conformal Radiation Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

Low levels of recruitment

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cancer Trials Ireland

4. Oversight

5. Study Description

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

Detailed Description

Pilot Study- Primary Objectives: Prospective evaluation of the technical feasibility of integrating PET-CT fusion in St Luke's Hospital Rate of PET-CT Scan based treatment delivery Pilot Study- Secondary Objectives: -Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan. Phase II Study- Primary Objective: -The safety of PET-CT scan based radiotherapy, with regard to loco-regional disease control. Phase II Study- Secondary Objectives: -Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Metastatic Cancer

Keywords

adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer, malignant pleural effusion, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

3-DCRT

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

computed tomography

Intervention Type

Radiation

Intervention Name(s)

3-dimensional conformal radiation therapy

Intervention Type

Radiation

Intervention Name(s)

fludeoxyglucose F 18

Intervention Type

Radiation

Intervention Name(s)

radiation therapy treatment planning/simulation

Primary Outcome Measure Information:

Title

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

Time Frame

2016

Title

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

Time Frame

2016

Secondary Outcome Measure Information:

Title

Acute and long-term radiation-induced toxicity

Time Frame

2016

Title

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

Time Frame

2016

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre Thirion, MD

Organizational Affiliation

Saint Luke's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Luke's Radiation Oncology Network

City

Dublin

ZIP/Postal Code

Country

Ireland

12. IPD Sharing Statement

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