Clinical trial · Interventional
Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation
NCT02189967CI-TRIAL-00046093completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this randomized multicentric phase II study it will be investigated whether an accelerated postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy single dose) may improve locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison to conventional fractionation (5 fractions per week, 2 Gy single dose).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| accelerated fraction | Radiation | — | UNRESOLVED |
| conventional fractionation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- conventional fractionation
- description
- radiotherapy with conventional fractionation (5 x 2Gy per week)
- interventionNames
- Radiation: conventional fractionation
- type
- ACTIVE_COMPARATOR
- label
- accelerated fraction
- description
- radiotherapy with accelerated fraction (7 x 2 Gy per week)
- interventionNames
- Radiation: accelerated fraction
Primary outcomes (1)
- measure
- assessment of local tumor control
- timeFrame
- 36 months after therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed non-small cell lung cancer * previous tumor resection with curative intention * postoperative indication for irradiation (\> pN1 and/ or R1) * R2-resection or recurrence postoperative/after adjuvant chemotherapy diagnosed by the restaging-imaging * exclusion of distant metastases (M0) * age \> 18 years * good general condition (ECOG performance status 0 or 1) * written informed consent * appropriate compliance to ensure close follow-up * women of childbearing age: adequate contraception Exclusion Criteria: * histologically confirmed small cell lung cancer * distant metastases * no written informed consent or lack of cooperation relating to therapy or follow-up * previous (\< 5 years) or concomitant other malignant disease (exception: malignant disease, which is very likely healed and not influenced therapy or follow up of the non-small cell lung cancer, e.g. carcinoma in-situ, basaliomas, very early skin cancers) * for proton therapy: heart pacemaker * previous radiotherapy of the thorax or lower neck region * pregnancy or lactation * participation in another intervention study or not completed follow-up of a intervention study. Exceptions are psychological studies, supportive or observation studies, the previous therapy of non-small cell lung cancer is in accordance with the guideline and the participation in radiotherapy studies is not excluded in the trial protocol of the previous study
References
Publications (2)
- DERIVEDButof R, Koi L, Lock S, Appold S, Drewes S, Koschel D, Kotzerke J, Nestle U, Adebahr S, Zips D, Heinzelmann F, Hehr T, Bucher D, Heide J, Belka C, Manapov F, Wasilewska-Tesluk E, Fleckenstein J, Krause M, Troost EGC, Baumann M. Accelerated vs. conventionally fractionated postoperative radiotherapy of non-small cell lung cancer-final results of the prematurely terminated PORTAF trial. Strahlenther Onkol. 2026 Mar;202(3):299-306. doi: 10.1007/s00066-025-02422-y. Epub 2025 Jul 15. PMID 40663146
- DERIVEDButof R, Simon M, Lock S, Troost EGC, Appold S, Krause M, Baumann M. PORTAF - postoperative radiotherapy of non-small cell lung cancer: accelerated versus conventional fractionation - study protocol for a randomized controlled trial. Trials. 2017 Dec 20;18(1):608. doi: 10.1186/s13063-017-2346-0. PMID 29262836