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Clinical Trial
. 2006 Dec;182(12):696-702.
doi: 10.1007/s00066-006-1577-x.

Hypofractionated stereotactic radiotherapy for primary and secondary intrapulmonary tumors: first results of a phase I/II study

Antje Ernst-Stecken  1 , Ulrike Lambrecht, Reinhold Mueller, Rolf Sauer, Gerhard Grabenbauer
Affiliations
Free PMC article
Clinical Trial

Hypofractionated stereotactic radiotherapy for primary and secondary intrapulmonary tumors: first results of a phase I/II study

Antje Ernst-Stecken et al. Strahlenther Onkol. 2006 Dec.
Free PMC article

Abstract
in English, German

Purpose: To evaluate the feasibility, efficacy, and side effects of dose escalation in hypofractionated stereotactic radiotherapy (hfSRT) for intrapulmonary tumors with the Novalis system (BrainLAB AG, Heimstetten, Germany).

Patients and methods: From 07/2003 to 01/2005, 21 patients/39 tumors were treated with 5 x 7 Gy (n = 21; total dose 35 Gy) or 5 x 8 Gy (n = 18; total dose 40 Gy). There were three cases of primary lung cancer, the remainder were metastases. Median gross tumor volume (GTV) and planning target volume (PTV) were 2.89 cm(3) (range, 0.15-67.94 cm(3)) and 25.75 cm(3) (range, 7.18-124.04 cm(3)), respectively.

Results: Rates of complete remission, partial remission, no change, and progressive disease were 51%, 33%, 3%, and 13%, respectively. No grade 4 toxicity occurred, nearly all patients had grade 1 initially. One grade 3 toxicity, i.e., dyspnea, was documented for a period of 6 months after therapy. Radiosurgery quality assurance guidelines could be met.

Conclusion: hfSRT of primary and secondary lung tumors using a schedule of five fractions at 7-8 Gy each was well tolerated. Further dose escalation is planned.

Auswertung der Durchführbarkeit, Wirksamkeit und Nebenwirkungen einer Phase-I/II-Studie zur Dosiseskalation bei hypofraktionierter stereotaktischer Radiotherapie (hfSRT) von Lungentumoren mit dem Novalis™-System (BrainLAB AG, Heimstetten).

21 Patienten/39 Tumoren wurden von Juli 2003 bis Januar 2005 mit 5 × 7 Gy (n = 21; Gesamtdosis [GD] 35 Gy) oder 5 × 8 Gy (n = 18; GD 40 Gy) bestrahlt. Drei Patienten hatten ein primäres Lungenkarzinom, die übrigen Metastasen. Das mediane „gross tumor volume”(GTV) und Planungszielvolumen (PTV) betrugen 2,89 cm3 (0,15–67,94 cm3) und 25,75 cm3 (7,18–124,04 cm3).

Eine komplette Remission, partielle Remission, keine Änderung und Progression fanden sich bei 51%, 33%, 3% und 13%. Nach initialer Grad-1-Toxizitat in fast allen Fälle trat keine Grad-4-Toxizitat auf. Eine Patientin erlitt eine Grad-3-Toxizität. Die RTOG-Qualitatskriterien für die Radiochirurgie wurden bei allen Patienten erfüllt.

Die hfSRT mit 5 × 7 Gy und 5 × 8 Gy wurde gut vertragen. Die Dosiseskalation wird fortgeführt.

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Figures

Figures 1a and 1b
Figures 1a and 1b
Patient setup with abdominal press. Treatment planning with CT scan (a), setup at the linear accelerator (b). Arrow showing the individual and marked impression by the abdominal press.
Figures 2a to 2e
Figures 2a to 2e
Case follow-up study. Treatment planning (a), three dynamic conformal arcs; follow-up at 6 months (b), 9 months (c), 12 months (d) and 15 months (e). Arrows showing the residual tumor (b) and the normal-tissue reactions (e) Case follow-up study. Follow-up at 15 months (e). Case follow-up study. Follow-up at 15 months (e).
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