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

NCT ID: NCT00958321

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31

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.

Conditions

Lung Cancer; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

3-DCRT

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

Group Type: EXPERIMENTAL

computed tomography

Intervention Type: PROCEDURE

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

fludeoxyglucose F 18

Intervention Type: RADIATION

radiation therapy treatment planning/simulation

Intervention Type: RADIATION

Interventions

computed tomography

Intervention Type: PROCEDURE

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

fludeoxyglucose F 18

Intervention Type: RADIATION

radiation therapy treatment planning/simulation

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Trials Ireland

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Thirion, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Luke's Hospital

Locations

St Luke's Radiation Oncology Network

Dublin, , Ireland

Countries

Ireland

Other Identifiers

CTRIAL-IE (ICORG) 06-35

Identifier Type: -

Identifier Source: secondary_id

EU-20925

Identifier Type: -

Identifier Source: secondary_id

CTRIAL-IE (ICORG)06-35

Identifier Type: -

Identifier Source: org_study_id