SUPR-3D: A randomized phase iii trial comparing simple unplanned palliative radiotherapy versus 3d conformal radiotherapy for patients with bone metastases: study protocol

Abstract Background Bone metastases in the lower spine and pelvis are effectively palliated with radiotherapy (RT), though this can come with side effects such as radiation induced nausea and vomiting (RINV). We hypothesize that high rates of RINV occur in part because of the widespread use of inexpensive simple unplanned palliative radiotherapy (SUPR), over more complex and resource intensive 3D conformal RT, such as volumetric modulated arc therapy (VMAT). Methods This is a randomized, multi-centre phase III trial of SUPR versus VMAT. We will accrue 250 patients to assess the difference in patient-reported RINV. This study is powered to detect a difference in quality of life between patients treated with VMAT vs. SUPR. Discussion This trial will determine if VMAT reduces early toxicity compared to SUPR and may provide justification for this more resource-intensive and costly form of RT. Trial registration Clinicaltrials.gov identifier: NCT03694015. Date of registration: October 3, 2018.

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8029 POSTER Health-Related Quality of Life (HRQoL)/Patient Reported Outcomes (PRO) of Patients (pts) With Partially Platinum Sensitive (PPS) Recurrent Ovarian Cancer (ROC) Treated in a Randomized Phase III Trial of Trabectedin and Pegylated Liposomal Doxorubicin (PLD) Vs PLD Alone (OVA-301) – an Exploratory Analysis

European Journal of Cancer ◽

10.1016/s0959-8049(11)72117-7 ◽

2011 ◽

Vol 47 ◽

pp. S536 ◽

Cited By ~ 2

Author(s):

I. Verqote ◽

M. Bidzinski ◽

J. Kelley ◽

S. Vasanthan ◽

I. Runnebaum ◽

...

Keyword(s):

Patient Reported Outcomes ◽

Pegylated Liposomal Doxorubicin ◽

Recurrent Ovarian Cancer ◽

Phase Iii ◽

Phase Iii Trial ◽

Platinum Sensitive ◽

Patient Reported ◽

Related Quality ◽

Health Related

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Patient-Reported Outcomes and Quality of Life with Sunitinib Versus Placebo for Pancreatic Neuroendocrine Tumors: Results From an International Phase III Trial

Targeted Oncology ◽

10.1007/s11523-016-0462-5 ◽

2016 ◽

Vol 11 (6) ◽

pp. 815-824 ◽

Cited By ~ 19

Author(s):

Aaron Vinik ◽

Andrew Bottomley ◽

Beata Korytowsky ◽

Yung-Jue Bang ◽

Jean-Luc Raoul ◽

...

Keyword(s):

Quality Of Life ◽

Neuroendocrine Tumors ◽

Patient Reported Outcomes ◽

Phase Iii ◽

Pancreatic Neuroendocrine Tumors ◽

Phase Iii Trial ◽

Patient Reported

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The patient’s perspective on treatment with dacomitinib: patient-reported outcomes from the Phase III trial ARCHER 1050

Future Oncology ◽

10.2217/fon-2020-0888 ◽

2020 ◽

Author(s):

Jean Paty ◽

Rickard Sandin ◽

Arlene Reisman ◽

Yi-Long Wu ◽

Maria Rita Migliorino ◽

...

Keyword(s):

Dose Reduction ◽

Repeated Measures ◽

Mixed Model ◽

Phase Iii ◽

Phase Iii Trial ◽

Early Improvement ◽

Patient Reported ◽

Eortc Qlq C30 ◽

Eortc Qlq

Aim: Patient-reported symptoms, functioning and overall quality of life (QoL) were compared between dacomitinib and gefitinib in ARCHER 1050. Patients & methods: Patients (n = 448) with advanced EGFR mutation-positive non-small-cell lung cancer completed the EORTC-QLQ-C30 questionnaire and its lung-specific module, LC-13. Mean scores over time were analyzed using a mixed model for repeated measures. Results: Both treatments showed early improvement in disease-related symptoms that was maintained during treatment. Treatment-related diarrhea and sore mouth decreased following dose reduction with dacomitinib. There were no clinically meaningful changes in functioning and overall QoL in either treatment group. Conclusion: Longer treatment duration, enabled by dose reduction, allowed patients on dacomitinib to improve treatment-related symptoms and maintain functioning and overall QoL for longer than gefitinib. Trial registration: ClinicalTrials.gov identifier: NCT01774721

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Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial

Journal of Radiation Research ◽

10.1093/jrr/rrz025 ◽

2019 ◽

Vol 61 (1) ◽

pp. 140-145 ◽

Cited By ~ 1

Author(s):

Taro Murai ◽

Masayuki Matsuo ◽

Hidekazu Tanaka ◽

Yoshihiko Manabe ◽

Taiki Takaoka ◽

...

Keyword(s):

Herbal Medicine ◽

Phase Ii ◽

Phase Ii Trial ◽

Controlled Trial ◽

Acute Radiation ◽

Phase Iii ◽

Phase Iii Trial ◽

Prospective Phase ◽

Radiation Induced

Abstract The purpose of this multi-institutional Phase II trial study was to prospectively investigate the efficacy of the herbal medicine TJ-14 for acute radiation-induced enteritis (ARE). TJ-14 was administered orally as a first-line treatment for ARE. The primary end point was efficacy at 1 week. The secondary end points were: (i) the efficacy of TJ-14 at 2 and 3 weeks after its administration, (ii) the quality of life score (FACT-G) at 1, 2 and 3 weeks after its administration, and (iii) adverse events. If the efficacy of TJ-14 was observed in eight patients or fewer, its efficacy was rejected. Results: Forty patients receiving pelvic radiotherapy were enrolled. Of these, 22 developed ARE and received TJ-14. Among these, 19 had cervical cancer and 9 received chemoradiotherapy. TJ-14 efficacy was shown in 19 out of the 22 patients (86%). Stool frequency per day at 1 week significantly decreased (mean ± SD: 4.9 ± 2.1 vs 3.7 ± 1.9, P = 0.02). This effect continued at 2 (2.2 ± 1.4, P = 0.004) and 3 weeks (2.1 ± 0.9, P = 0.05). Thirteen out of the 22 patients (59%) continued TJ-14 until the end of radiotherapy. FACT-G score deterioration was not observed after the administration of TJ-14. Grade 1 hypokalemia was observed in 4 patients, and Grade 1 constipation in 3. We concluded that TJ-14 is sufficiently promising to be examined in a Phase III trial. A randomized controlled trial is currently being planned.

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