Prospective Evaluation of PET-CT Scan in Patients With Non-operable or Non-resectable NSCLC Treated by Radical 3-Dimensional Conformal Radiation Therapy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot)
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
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
Outcomes
Primary Outcomes
Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot)
Time Frame: 2016
Rate of loco-regional recurrence outside the PET-CT planning target volume (PTV) but within conventional 3-D PTV (Phase II)
Time Frame: 2016
Secondary Outcomes
- Acute and long-term radiation-induced toxicity(2016)
- Comparison of dose delivery to organs at risk, according to planning method(2016)