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Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET


Inclusion Criteria:



- histologically proved NSCLC

- UICC-stage I-III, no resection planned

- complete staging < 6 wks before treatment including cranial CT

- ECOG <3, Karnofsky-Index >60%

- age > 18 <

- FEV1 > 1,0 l or >35%

- RT-planning according to protocol feasible

- chemotherapy feasible

- written informed consent

Exclusion Criteria:

- neuroendocrine tumors, plain broncho-alveolar-cell ca.

- distant metastases, supraclavicular lymph node metastases

- malignant pleural effusion

- resection of actual tumor performed

- inclusion in other study protocol

- chemotherapy due to actual tumor before FDG-PET

- induction-chemotherapy

- acute vena cava superior syndrome

- second malignancy other than basalioma

- pregnancy, lactation

- heart insufficiency NYHA III/IV

- pneumoconiosis with active inflammatory changes of mediastinal lymph nodes

- acute broncho-pulmonary infection at time of PET-examination

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

local progression free survival

Outcome Time Frame:

actuarial

Safety Issue:

No

Principal Investigator

Ursula Nestle, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitätsklinikum Freiburg, Germany

Authority:

Germany: Ethics Commission

Study ID:

AG NUK/RT 2006-1

NCT ID:

NCT00697333

Start Date:

May 2009

Completion Date:

February 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • FDG-PET
  • Radiotherapy
  • planning
  • target volumes
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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