scholarly journals Feasibility and Acute Toxicity of Pancreatic Stereotactic Body Radiotherapy with or without Hypofractionated Elective Nodal Irradiation

2020 ◽  
Vol 108 (3) ◽  
pp. e580-e581
Author(s):  
J.A. Miller ◽  
D.A.S. Toesca ◽  
J.R.M. Baclay ◽  
E. Pollom ◽  
D.T. Chang
Keyword(s):  
Acute Toxicity ◽  
Stereotactic Body Radiotherapy ◽  
Elective Nodal Irradiation

scholarly journals Phase II study of stereotactic body radiotherapy with hydrogel spacer for prostate cancer: acute toxicity and propensity score-matched comparison

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Mami Ogita ◽  
Hideomi Yamashita ◽  
Yuki Nozawa ◽  
Sho Ozaki ◽  
Subaru Sawayanagi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Propensity Score ◽  
Acute Toxicity ◽  
Phase Ii ◽  
Stereotactic Body Radiotherapy ◽  
Phase Ii Study ◽  
Summary Score ◽  
Trial Registration ◽  
Gu Toxicity ◽  
Patient Reported

Abstract Background The efficacy of a hydrogel spacer in stereotactic body radiotherapy (SBRT) has not been clarified. We evaluated the safety and efficacy of SBRT in combination with a hydrogel spacer for prostate cancer. Methods This is a prospective single-center, single-arm phase II study. Prostate cancer patients without lymph node or distant metastasis were eligible. All patients received a hydrogel spacer insertion, followed by SBRT of 36.25 Gy in 5 fractions with volumetric modulated arc therapy. The primary endpoint was physician-assessed acute gastrointestinal (GI) toxicity within 3 months. The secondary endpoints were physician-assessed acute genitourinary (GU) toxicity, patient-reported outcomes evaluated by the EPIC and FACT-P questionnaires, and dosimetric comparison. We used propensity score-matched analyses to compare patients with the hydrogel spacer with those without the spacer. The historical data of the control without a hydrogel spacer was obtained from our hospital’s electronic records. Results Forty patients were enrolled between February 2017 and July 2018. A hydrogel spacer significantly reduced the dose to the rectum. Grade 2 acute GI and GU toxicity occurred in seven (18%) and 17 (44%) patients. The EPIC bowel and urinary summary score declined from the baseline to the first month (P < 0.01, < 0.01), yet it was still significantly lower in the third month (P < 0.01, P = 0.04). For propensity score-matched analyses, no significant differences in acute GI and GU toxicity were observed between the two groups. The EPIC bowel summary score was significantly better in the spacer group at 1 month (82.2 in the spacer group and 68.5 in the control group). Conclusions SBRT with a hydrogel spacer had the dosimetric benefits of reducing the rectal doses. The use of the hydrogel spacer did not reduce physician-assessed acute toxicity, but it improved patient-reported acute bowel toxicity. Trial registration: Trial registration: UMIN-CTR, UMIN000026213. Registered 19 February 2017, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029385.

Phase I study of stereotactic body radiotherapy following radical prostatectomy.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS158-TPS158 ◽  
Author(s):  
Leslie Ballas ◽  
Monish Aron ◽  
Shamim Jhimlee ◽  
Igor Shuryak ◽  
Tanya B. Dorff ◽  
...  
Keyword(s):  
Acute Toxicity ◽  
Adverse Events ◽  
Phase I ◽  
Dose Level ◽  
Dose Escalation ◽  
Stereotactic Body Radiotherapy ◽  
Phase I Study ◽  
Dose Fractionation ◽  
Level 3 ◽  
Dose Levels

TPS158 Background: Although multiple Phase I/II studies demonstrate safety and low rates of toxicity following stereotactic body radiotherapy (SBRT) to the intact prostate, there are limited data on hypofractionation and SBRT after prostatectomy. This Phase I study was performed to evaluate acute toxicity associated with dose escalation from 3.6 Gy per fraction to 7.1 Gy per fraction to the prostate bed in the post-prostatectomy treatment of prostate cancer. We hypothesize that the toxicity of escalating the dose per fraction to the prostate fossa in the post-operative setting will be well tolerated; and we expect toxicity to be comparable to normal fractionation schedules. Methods: This study (NCT02446366) was designed to look at acute toxicity, defined as toxicity that occurred within the first 10 weeks of RT, of different dose fractionation schemes in the post-prostatectomy setting. The doses chosen for dose escalation on this study are based on an equivalent biological effective dose to a previously published hypofractionated post-prostatectomy study that showed no increase in acute bowel or bladder toxicity. The dose levels are as follows: Level 1 -3.6 Gy x 15 fractions; Level 2- 4.7 Gy x 10 fractions; Level 3 - 7.1 Gy x 5 fractions. Eligibility for participation on the trial was for patients who had pT3N0 disease regardless of margin status in the post-prostatectomy setting, pT2N0 patients with positive margin or with a negative surgical margin and a rising post-operative PSA. Patients could be on concurrent ADT and enroll on this study. Dose was escalated according to a 6+6 schema. For purposes of deciding whether to escalate to a new dose level, expand a dose level or de-escalate from a dose level, we used toxicities and adverse events that occur during the 1st 10 weeks after completion of radiotherapy. Six patients were enrolled on each new dose level with a total of 12 patients required at the maximum tolerated dose. Dose-limiting toxicity (DLT) was defined as grade 3 or worse fatigue, gastrointestinal (GI) or genitourinary (GU) toxicity by Common Terminology Criteria of Adverse Events (version 4.03). Dose levels 1 and 2 have been completed without any DLT. Dose level 3 has enrolled 9/12 patients without any DLT. Clinical trial information: NCT02446366.

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