Clinical trial NCT00958321: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2009-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot)
timeFrame: 2016
measure: Rate of loco-regional recurrence outside the PET-CT planning target volume (PTV) but within conventional 3-D PTV (Phase II)
timeFrame: 2016
Secondary outcomes:
measure: Acute and long-term radiation-induced toxicity
timeFrame: 2016
measure: Comparison of dose delivery to organs at risk, according to planning method
timeFrame: 2016
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St Luke's Radiation Oncology Network
Study officials:
affiliation: Saint Luke's Hospital
name: Pierre Thirion, MD
role: PRINCIPAL_INVESTIGATOR
References: