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Spots Global Cancer Trial Database for Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study

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Trial Identification

Brief Title: Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study

Official Title: The Pilot Study of Neoadjuvant Chemotherapy of FIRINOX for Patients With Borderline Resectable Pancreatic Cancer

Study ID: NCT02148549

Interventions

FIRINOX

Study Description

Brief Summary: FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen

Detailed Description: FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. FOLFIRINOX is one of the high response rate treatment regimen , the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and diarrhea were significantly higher in the FOLFIRINOX group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen. The investigators also evaluate the optimal treatment schedule of FIRINOX therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic cancer.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Nagoya University, Nagoya, Aichi, Japan

Kobe University, Kobe, Hyogo, Japan

Nara Prefectual Medical University, Kashihara, Nara, Japan

Kansai Medical University, Hirakata, Osaka, Japan

Osaka University, Suita, Osaka, Japan

Hiroshima University, Hiroshima, , Japan

Osaka City University, Osaka, , Japan

Osaka Medical Center for Cancer and CVD, Osaka, , Japan

Wakayama Medical University, Wakayama, , Japan

Contact Details

Name: Hiroki Yamaue, M.D., PhD

Affiliation: Wakayama Medical University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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