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Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00697333
Acronym
PET-Plan
Enrollment
200
Registered
2008-06-13
Start date
2009-05-31
Completion date
2017-05-31
Last updated
2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC, FDG-PET, Radiotherapy, planning, target volumes

Brief summary

Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions. Primary endpoint is the local disease control in the chest.

Detailed description

Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions. Primary endpoint is the local disease control in the chest

Interventions

PROCEDURErestriction of radiotherapy to FDG-PET positive areas only

Restriction of target volumes to areas positive in positron emission tomography using fluoro-deoxy-glucose

Sponsors

Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
time to local progressionactuarialTime from randomization to first evidence of local progression or last follow up

Secondary

MeasureTime frameDescription
in and out field progressionactuarialTime from randomization to progression or last follow up
Overall survivalactuarialTime from randomization to death or last follow up
normal tissue toxicityactuarialTime from randomization to death or last follow up

Countries

Germany

Contacts

Primary ContactU. Nestle, Prof.
ursula.nestle@uniklinik-freiburg.de49-761-270
Backup ContactA. L. Grosu, Prof.
anca.grosu@uniklinik-freiburg.de49-761-270

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026