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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00958321
• Other study ID #: CTRIAL-IE (ICORG)06-35
• Secondary ID: CTRIAL-IE (ICORG
• Status: Terminated
• Phase: Phase 2
• First received: August 12, 2009
• Last updated: May 23, 2017
• Start date: March 2007

Study information

• Verified date: May 2017
• Source: Cancer Trials Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Procedure:
• computed tomography

Radiation:
• 3-dimensional conformal radiation therapy

• fludeoxyglucose F 18

• radiation therapy treatment planning/simulation

Locations

Country	Name	City	State
Ireland	St Luke's Radiation Oncology Network	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Trials Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot)		2016
Primary	Rate of loco-regional recurrence outside the PET-CT planning target volume (PTV) but within conventional 3-D PTV (Phase II)		2016
Secondary	Acute and long-term radiation-induced toxicity		2016
Secondary	Comparison of dose delivery to organs at risk, according to planning method		2016