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Nagoya University Pancreatic Tumor Board trial 08 (NUPAT-08)

Nagoya University Pancreatic Tumor Board trial 08 (NUPAT-08)

Takami Hideki

Nagoya University Graduate School of Medicine

65 Tsurumai-cho, Showa-ku, Nagoya

takami.hideki.r7@f.mail.nagoya-u.ac.jp

Takami Hideki

Nagoya University Graduate School of Medicine

65 Tsurumai-cho, Showa-ku, Nagoya

+81-52-744-2245

takami.hideki.r7@f.mail.nagoya-u.ac.jp

Recruiting

Jan. 01, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Locally advanced pancreatic cancer
2. Age 20<= and <=79
3. Performance status 0-1

1. distant metastasis
2. severe drug allergy
3. viable multiple primary cancer
4. gastrointestinal invasion
5. apparent infectious status
6. history of abdominal radiotherapy
7. pregnant or breastfeeding female

Both

Locally advanced pancreatic cancer

Concurrent CRT group
Patients will undergo chemotherapy with 100mg/m2 nab-PTX and 800 mg/m2 gemcitabine for 8 weeks. Concurrent radiotherapy will be also performed. After chemoradiotherapy, patients will undergo chemotherapy with 125mg/m2 nab-PTX and 1000 mg/m2 gemcitabine for 16 weeks.
Initial CRT group
As an initial systemic therapy, patients will undergo chemotherapy with 125mg/m2 nab-PTX and 1000 mg/m2 gemcitabine for 16 weeks. Then, patients will undergo chemoradiotherapy with 100mg/m2 nab-PTX and 800 mg/m2 gemcitabine for 8 weeks.

* Completion of 8 weeks chemo(radio)therapy is defined as completion of protocol therapy.
* Curative intent surgery will be considered after completion of protocol therapy.

2-year survival rate

Recurrence free survival, overall survival, pathological tumor reduction according to Evans grade, Tumor response defined by RECIST, rate of completion of preoperative therapy, rate of adverse effect, surgical morbidity, early tumor shrinkage, time to treatment failure

+81-52-744-2479

Sept. 23, 2020

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