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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Metastatic Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot)

Outcome Time Frame:

2016

Safety Issue:

No

Principal Investigator

Pierre Thirion, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Luke's Hospital

Authority:

Ireland: Research Ethics Committee

Study ID:

CDR0000639298

NCT ID:

NCT00958321

Start Date:

March 2007

Completion Date:

Related Keywords:

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

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