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

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

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

Study Overview

• Status: Terminated
• Conditions: Lung Cancer; Metastatic Cancer
• Intervention / Treatment: Procedure: computed tomography; Radiation: fludeoxyglucose F 18; Radiation: 3-dimensional conformal radiation therapy; Radiation: radiation therapy treatment planning/simulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 6
    • St Luke's Radiation Oncology Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3-DCRT; Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT	Procedure: computed tomography; Radiation: fludeoxyglucose F 18; Radiation: 3-dimensional conformal radiation therapy; Radiation: radiation therapy treatment planning/simulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Acute and long-term radiation-induced toxicity	2016
Comparison of dose delivery to organs at risk, according to planning method	2016

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland
• Investigators: Principal Investigator: Pierre Thirion, MD, Saint Luke's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 12, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimate): August 13, 2009

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; 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; malignant pleural effusion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: CTRIAL-IE (ICORG)06-35; CTRIAL-IE (ICORG) 06-35; EU-20925