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PET-Plan - Optimization of radiotherapy planning in patients with inoperable locally advanced NSCLC using F-18-FDG-PET

Organizational Data

DRKS-ID:
DRKS00002178
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2012-04-24
Last update in DRKS:
2019-11-29
Registration type:
Retrospective

Acronym/abbreviation of the study

PET-PLAN

URL of the study

No Entry

Brief summary in lay language

The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of FDG-PET and CT-based macroscopic tumor and lymph nodes together with elective nodal irradiation (Arm A) vs. only FDG-PET-based irradiation of tumor and lymph node areas (Arm B). This comparison will be done on evaluation of locoregional tumor control. At the same time, the safety of the approach will be investigated based on the rate of recurrences outside the target volumes and regarding normal tissue toxicity.

Brief summary in scientific language

Simultaneous radio-chemotherapy in locally advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional FDG-PET and CT-based radiotherapy planning with irradiation of the macroscopic tumor and involved lymph node regions together with elective nodal irradiation vs. irradiation only of FDG-PET positive tumor lesions and lymph node regions.

Health condition or problem studied

ICD10:
C34 - Malignant neoplasm of bronchus and lung
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Arm A: 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
Arm 2:
Arm B: Irradiation of all tumor manifestations detectable by positron emission tomography using fluoro-deoxy-glucose (F18FDG-PET) including affected lymph node stations with a dose-escalated irradiation with a minimum of 60 and a maximum of 74 Gy/2Gy. Radiotherapy is restricted to FDG-PET positive areas only.

Endpoints

Primary outcome:
Time to locoregional progression.
Secondary outcome:
Rate of acute and late normal tissue toxicity. Overall survival (inten-to-treat). Progression free survival including progression in and out of the irradiaton field as well as distant failures. Rate of mediastinal in- and out field failures. Total PTV reference dose and PTV volumes in the study arms.

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Austria
  • Germany
  • Switzerland
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Klinik für Strahlenheilkunde Freiburg im Breisgau
  • Medical center MVZ für Strahlentherapie; PET-Zentrum Bad Berka
  • Medical center Klinik für Nuklearmedizin; Strahlenklinik Augsburg
  • University medical center Inselspital, U.klinik f. Radio-Onkologie; U.klinik Nuklearmed. Bern, CH
  • University medical center Klinik für Strahlentherapie; Klinik für Nuklearmedizin Berlin
  • Medical center Maria Hilf: Klinik f. Nuklearmedizin, Klinik f. Strahlentherapie Mönchengladbach
  • Medical center Inst. f. Radioonkologie-Strahlentherapie; Klinik f. diagn. u. therap. Nuklearmed. Fulda
  • Medical center Helios Klinik f. Strahlentherapie u. Radioonkologie, Klinik f. Nuklearmedizin Wuppertal
  • Medical center Radio-Onkologie Offenburg-Gengenbach/Ortenau
  • University medical center Klinik f. Strahlenther. u. Radioonkol.; Klinik f. Nuklearmedizin Homburg
  • University medical center Klinik f. Strahlentherapie; Klinik f. Nuklearmedizin Kiel
  • Medical center Landesklinikum, Strahlentherapie-Radioonkologie Krems, A
  • University medical center Klinik f. Strahlentherapie, Klinik f. Nuklearmedizin Rostock
  • University medical center Klinik f. Nuklearmedizin, Klinik f. Strahlentherapie Tübingen
  • University medical center Klinik f. Radioonkologie, Klinik f. Nuklearmedizin Mainz
  • University medical center AKH Med. Univ.campus: Univ.klinik f. Strahlentherapie, Univ.klinik f. Radiologie u. Nuklearmedizin Wien
  • University medical center Technische Universität: Klinik f. Radioonkologie, Klinik f. Nuklearmedizin München
  • Doctor's practice Kiel/Neumünster
  • Medical center Mutterhaus der Borromäerinnen; Lungenkrebszentrum am KH der Barmherzigen Brüder Trier
  • Medical center Helios Klinik f. Strahlentherapie, Inst. f. Nuklearmedizin Schwerin
  • Medical center Städt. Klinikum: Klinik f. Strahlentherapie; Klinik f. Nuklearmedizin Karlsruhe
  • Medical center KH Praxis f. Strahlentherapie u. Radioonkologie, Klinik f. Nuklearmedizin Weilheim
  • Medical center Marienhospital: Klinik f. Strahlenther. u. Palliativmed., MVZ Nuklearmedizin Stuttgart
  • University medical center Zentrum bildgebende Diagnostik u. Intervention; Klinik Strahlenther. u. Radioonkol.; Klinik Nuklearmedizin Hamburg-Eppendorf
  • University medical center Zentrum für Radiologie: Klinik f. Strahlentherapie, Klinik f. Nuklearmedizin Magdeburg

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2009-04-06
Planned study completion date:
No Entry
Actual Study Completion Date:
2017-11-30
Target Sample Size:
394
Final Sample Size:
205

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Written informed Consent. Histologically proven NSCLC, UICC-stage II-III. Resection planned according to interdisciplinary consensus. Complete staging < 6 weeks before initiation of treatment including cranial MRI or, if not possible, cranial CT. ECOG < 3, Karnofsky-Index > 60%. Age > 18 years. FEV1 > 1,0 l or >35% of expected value. RT-planning according to both protocol arms feasible. Application of chemotherapy feasible according to the treating study center specific standards.

Exclusion Criteria

Neuroendocrine tumors or broncho-alveolar-cell carcinoma. Distant metastases, supraclavicular lymph node metastases. Malignant pleural or pericardial effusion. Acute superior vena cava syndrome. Recent pulmonary resection of the present NSCLC. Parallel participation in another clinical trial. Chemotherapy or targeted therapy for to present NSCLC before study inclusion. Induction chemotherapy. Second malignancy (other than basalioma) within 2 years of study inclusion. Pregnancy or lactation. Application of chemotherapy not possible according to study center institutional standards. Heart insufficiency NYHA III/IV. FDG-PET associated exclusion criteria: Detection of distant metastases or a secondary malignancy. Downstaging or change of therapeutical concept. Acute broncho-pulmonary infection at time of the FDG-PET acquisition. Active inflammatory changes of mediastinal lymph nodes associated with pneumoconiosis, sarcoidosis or tuberculosis. FDG-PET acquisition not in radiotherapy planning position. Co-registration of FDG-PET and CT not according to protocol guidelines.

Addresses

Primary Sponsor

Klinik für Strahlenheilkunde
Prof. Dr. med. Ursula Nestle
Robert-Koch-Str. 6
79106 Freiburg
Germany
Telephone:
0761/27095390
Fax:
0761/27095110
Contact per E-Mail
URL:
http://www.uni-freiburg.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Prof. Ursula Nestle
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
+49 761 270-95200
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Prof. Ursula Nestle
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
+49 761 270-95200
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Deutsche Krebshilfe
Buschstr. 32
53113 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2008-07-28
Ethics committee number:
276/08
Vote of the Ethics Committee:
Approved
Date of the vote:
2008-07-30

Further identification numbers

Other primary registry ID:
NCT00697333 - ClinicalTrials.gov
EudraCT Number:
No Entry
Other secondary IDs:
UKF001781 - Register klinischer Studien des Universitätsklinikums Freiburg
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
Studienprotokoll V11
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry