Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC (PET-Plan)

Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Procedure: restriction of radiotherapy to FDG-PET positive areas only

Study type: Interventional

Funder types: Other

Identifiers

NCT00697333

AG NUK/RT 2006-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

A

No Intervention group

Description:

Irradiation of all tumor manifestations detectable by CT and/or positron emission tomography using fluoro-deoxy-glucose including a part of eventual atelectasis and the whole affected lymph node stations by 60 - 74 Gy/2Gy) irradiation of elective lymph node stations up to 50 Gy/2 Gy

B

Experimental group

Description:

Irradiation of all tumor manifestations detectable by positron emission tomography using fluoro-deoxy-glucose including the whole affected lymph node stations by 60 - 74 Gy/2Gy

Treatment:

Procedure: restriction of radiotherapy to FDG-PET positive areas only