Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Fluorouracil

Oxaliplatin

Folfirinox

Topoisomerase I Inhibitors

Enzyme Inhibitors

Neoadjuvant chemotherapy 4 courses of FIRINOX early 5 patients, and 8 courses of FIRINOX subsequent 5 patients

FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.

FIRINOX

Hiroki Yamaue, M.D., PhD

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

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.

Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study

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

Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.

Wakayama Medical University

Dean & Professor

Symptoms and General Pathology

Carcinoma

Neoplasm Metastasis

Colorectal Neoplasms

Neoplasms, Second Primary

Liver Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Liver Diseases

Hematinics

Micronutrients

Vitamins

Liver Extracts

Leucovorin

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Adecatumumab,6-9mg/kg, every 14 days, 24 cycles

Adecatumumab

FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles

Adecatumumab and FOLFOX

FOLFOX 4

Peter Neuhaus, Prof. Dr.

Patrick Dufour, Pr. Dr.

The purpose of this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX alone.

Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases

A Randomized, Open-label, Controlled, Multi-center Phase II Study to Evaluate the Efficacy and Safety of Adecatumumab Alone or Sequentially to FOLFOX Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases

Amgen Research (Munich) GmbH

Recurrence

Neoplasm Recurrence, Local

Disease Attributes

FOLFIRI \* 6 cycles +/- radiotherapy -\> surgery -\> FOLFIRI \* 6 cycles

Surgery -\> FOLFIRI \* 12 cycles +/- radiotherapy

5-fluorouracil

Local radiotherapy

R0 resection

Jian Xiao, MD

Ping Lan, MD

Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase III mode.

Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin

Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment

Adverse events grade that greater than 3 is considered secondary endpoint, according to the Common Terminology Criteria for Adverse Events Version 3.0.

Sixth Affiliated Hospital, Sun Yat-sen University

Professor

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Gemcitabine

Celecoxib

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

one group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection.

the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection, and receive additional celecoxib every days during chemotherapy period.

One group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2.

the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2, and receive additional celecoxib 200mg bid every days during chemotherapy period.

Tingbo Liang

Xueli Bai

Qi Chen, MD,PhD

The prognosis of pancreatic cancer is extremely poor, even in those patients who had underwent surgery, the 5-year survival is still less than 10%. Current guidelines recommend Gemcitabine monotherapy for R0 resection of pancreatic cancer. Inflammation plays an critical role in the development and progression of pancreatic cancer. Here we intend to assess the synergistic effect of using celecoxib in combination with gemcitabine on the treatment of R0 resection of pancreatic cancer.

We choose those patients who had underwent the R0 resection of pancreatic ductal adenocarcinoma patients, and divided them into two groups randomly, one group patients were given gemcitabine only according the current guidelines, while the other group patients were given gemcitabine combined with the anti-inflammation agent Celecoxib. The disease free survivals, drugs related side effects, overall survivals and other endpoints events were recorded and analyzed, to assess the celecoxib could or couldn't synergist the gemcitabine anti tumor effect on R0 resection pancreatic cancer patients.

Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer

the duration between the date of surgery and the date of disease relapse

the duration between the date of surgery and the date of patient death

assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score

according to Common Toxicity Criteria for Adverse Effects version 4

Second Affiliated Hospital, School of Medicine, Zhejiang University

Chairman of Department of Hepatobiliary & Pancreatic Surgery, Vice president of the Second Affiliated Hospital, Zhejiang University School of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study	NCT02148549	Patients With B...	FIRINOX	20 Years - 74 Years	Wakayama Medical University
Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases	NCT00866944	Liver Metastase... Colorectal Canc...	Adecatumumab Adecatumumab an... FOLFOX 4	18 Years -	Amgen Research (Munich) GmbH
Neoadjuvant FIRINOX for Borderline Resectable Pancreatic Cancer - a Pilot Study	NCT02148549	Patients With B...	FIRINOX	20 Years - 74 Years	Wakayama Medical University
Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin	NCT02087475	Colorectal Neop... Effects of Chem... Surgery Metastasis Local Neoplasm ...	Irinotecan 5-fluorouracil Local radiother... R0 resection	18 Years - 80 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases	NCT00866944	Liver Metastase... Colorectal Canc...	Adecatumumab Adecatumumab an... FOLFOX 4	18 Years -	Amgen Research (Munich) GmbH
Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer	NCT03498326	Pancreatic Canc... Chemotherapy Ef...	Gemcitabine Gemcitabine	18 Years - 90 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University

Spots Global Cancer Trial Database for r0 resection

Every month we try and update this database with for r0 resection cancer trials from around the world to help patients and their families find trials that might be right for them.
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