Prospective Evaluation of PET-CT Scan in Patients With Non-operable or Non-resectable NSCLC Treated by Radical 3-Dimensional Conformal Radiation Therapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot)
Study 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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
3-DCRT
Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT
Intervention: 3-dimensional conformal radiation therapy (Radiation)
3-DCRT
Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT
Intervention: fludeoxyglucose F 18 (Radiation)
3-DCRT
Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT
Intervention: radiation therapy treatment planning/simulation (Radiation)
3-DCRT
Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT
Intervention: computed tomography (Procedure)
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)