Nagoya University Pancreatic Tumor Board trial 08

JRCT ID: jRCTs041200054

Registered date:22/10/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Locally advanced pancreatic cancer
• Date of first enrollment: 01/01/2021
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: 2-year survival rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Takami Hideki