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Clinical Trial
. 2022 Jun 1;24(6):974-983.
doi: 10.1093/neuonc/noab270.

Phase II trial of response-based radiation therapy for patients with localized germinoma: a Children's Oncology Group study

Ute Bartels  1 , Arzu Onar-Thomas  2 , Sunita K Patel  3 , Dennis Shaw  4 , Jason Fangusaro  5 , Girish Dhall  6 , Mark Souweidane  7 , Aashim Bhatia  8 , Leanne Embry  9 , Christine L Trask  10 , Erin S Murphy  11 , Shannon MacDonald  12 , Shengjie Wu  2 , James M Boyett  2 , Sarah Leary  11 , Maryam Fouladi  13 , Amar Gajjar  14 , Soumen Khatua  15
Affiliations
Clinical Trial

Phase II trial of response-based radiation therapy for patients with localized germinoma: a Children's Oncology Group study

Ute Bartels et al. Neuro Oncol. .

Abstract

Background: The study aimed to evaluate whether simplified chemotherapy followed by dose-reduced irradiation was effective for treating patients (ages 3-21 years) with localized germinoma. The primary endpoint was 3-year progression-free survival (PFS) rate.

Methods: Patients with a complete response to chemotherapy with carboplatin and etoposide received 18 Gy WVI + 12 Gy boost to the tumor bed. Patients with partial response proceeded to 24 Gy WVI + 12 Gy. Longitudinal cognitive functioning was evaluated prospectively on ALTE07C1 and was a primary study aim.

Results: One hundred and fifty-one patients were enrolled; 137 were eligible. Among 90 evaluable patients, 74 were treated with 18 Gy and 16 with 24 Gy WVI. The study failed to demonstrate noninferiority of the 18 Gy WVI regimen compared to the design threshold of 95% 3-year PFS rate, where, per design, patients who could not be assessed for progression at 3 years were counted as failures. The Kaplan-Meier (KM)-based 3-year PFS estimates were 94.5 ± 2.7% and 93.75 ± 6.1% for the 18 Gy and 24 Gy WVI cohorts, respectively. Collectively, estimated mean IQ and attention/concentration were within normal range. A lower mean attention score was observed at 9 months for patients treated with 24 Gy. Acute effects in processing speed were observed in the 18 Gy cohort at 9 months which improved at 30-month assessment.

Conclusions: While a failure according to the prospective statistical noninferiority design, this study demonstrated high rates of chemotherapy responses, favorable KM-based PFS and OS estimates in the context of reduced irradiation doses and holds promise for lower long-term morbidities for patients with germinoma.

Keywords: braintumor; germinoma; response-based radiation.

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Figures

Fig. 1
Fig. 1
Treatment schematic.
Fig. 2
Fig. 2
CONSORT diagram.
Fig. 3
Fig. 3
(A, B) KM curves for 18 and 24 Gy WVI, respectively.
See this image and copyright information in PMC

Comment in

References

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