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

Cancer Trials Ireland

Status and phase

Terminated

Phase 2

Conditions

Metastatic Cancer

Lung Cancer

Treatments

Radiation: fludeoxyglucose F 18

Radiation: 3-dimensional conformal radiation therapy

Procedure: computed tomography

Radiation: radiation therapy treatment planning/simulation

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00958321

CTRIAL-IE (ICORG)06-35

CTRIAL-IE (ICORG) 06-35

EU-20925

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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