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Clinical Trial
. 2015 May 20;10(5):e0127587.
doi: 10.1371/journal.pone.0127587. eCollection 2015.

Clinical trial of prophylactic extended-field carbon-ion radiotherapy for locally advanced uterine cervical cancer (protocol 0508)

Masaru Wakatsuki  1 , Shingo Kato  2 , Hiroki Kiyohara  3 , Tatsuya Ohno  4 , Kumiko Karasawa  1 , Tomoaki Tamaki  2 , Ken Ando  5 , Hirohiko Tsujii  1 , Takashi Nakano  3 , Tadashi Kamada  1 , Makio Shozu  6 ; Working Group of the Gynecological Tumor
Collaborators, Affiliations
Clinical Trial

Clinical trial of prophylactic extended-field carbon-ion radiotherapy for locally advanced uterine cervical cancer (protocol 0508)

Masaru Wakatsuki et al. PLoS One. .

Erratum in

Abstract

To evaluate the efficacy and the toxicity of prophylactic extended-field carbon-ion radiotherapy (C-ion RT, Protocol 0508) for locally advanced squamous cell carcinoma of the uterine cervix in phase I / II clinical trial. Between May 2006 and January 2012, 26 patients of Protocol 0508 were treated with C-ion RT. The numbers of patients with stage IIB, IIIB, and IVA disease were 13, 11, and 2, respectively. Twenty patients had pelvic lymph node metastases. Median tumor size was 6.1 cm (range, 4.0–10.0 cm). The treatment consisted of extended-field irradiation of 39.0 gray equivalents (GyE) in 13 fractions, and additional 15.0 GyE in 5 fractions was given to the gross tumor volume (GTV) and surrounding tissues. With regard to local boost, 18.0 GyE in 2 fractions was given to GTV only. Total dose to the cervical tumor was 72.0 GyE over 20 fractions. The median follow-up period was 37 months. Twenty-one patients had grade 1 or 2 acute gastrointestinal toxicity, but all patients completed the treatment on schedule. There were no grade 3 or higher late complications, with 8 patients having grade 1 or 2 toxicities, 1 had grade 2 gastrointestinal toxicity and 2 had grade 2 genitourinary toxicity. Four patients (15.4%) developed local recurrence, and 8 patients (30.8%) had distant metastases. The 2-year local control rate, progression-free survival rate and overall survival rate were 83.6%, 61.5% and 73.1%, respectively. There were no severe acute or late complications in this trial. Prophylactic extended-field C-ion RT for locally advanced squamous cell carcinoma of the uterine cervix was a safe treatment. Although the number of patients in this study was small, the results support further investigations to confirm the therapeutic efficacy and to avoid or reduce toxicity.

Trial registration: UMIN-CTR UMIN000016169.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Study Design.
Fig 2
Fig 2. Dose distribution of C-ion RT; Isodose curves of carbon-ion radiotherapy for locally advanced cervical cancer are superimposed on axial and sagittal computed tomography images for the total irradiation plan.
Highlighted are 95% (red), 90% (yellow), 83% (orange), 71% (pink), 51% (green), 30% (blue), and 10% (purple) isodose curves.
Fig 3
Fig 3. The local control, progression-free survival and overall survival curves; Local control (red line), progression-free survival (green line), and overall survival curves (blue line) are shown for all patients treated with carbon-ion radiotherapy.
Fig 4
Fig 4. The local control in patients with tumors < 50 mm, 50–70 mm, and > 70 mm.
See this image and copyright information in PMC

References

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