The Combination Chemotherapy of SIRIOX as First‑Line Chemotherapy for Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03403101|
Recruitment Status : Unknown
Verified January 2018 by Xian-Jun Yu, Fudan University.
Recruitment status was: Recruiting
First Posted : January 18, 2018
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Pancreatic Ductal||Drug: S1 Drug: Oxaliplatin Drug: Irinotecan||Phase 2|
Pancreatic cancer (mainly pancreatic ductal adenocarcinoma, PDAC) is a disease with extremely poor prognosis, and is often fatal. Surgical resection is the only potentially curative technique for management of PDAC, but only approximately 15% to 20% of patients are candidates for pancreatectomy at the time of diagnosis Gemcitabine (Gem) is widely used as a standard chemotherapeutic agent for advanced pancreatic cancer. FOLFIRINOX (fluoropyrimidine/leucovorin plus irinotecan and oxaliplatin), compared with Gem, has been proved to significantly improve the objective response rate (31.6% VS. 9.4%, P < 0.001) and prolong the median survival time (11.1 months VS. 6.8 months, P < 0.001) for patients with metastatic pancreatic ductal adenocarcinoma(PDAC), who had a performance status of ECOG 0-1 score. However, it is undeniable that the adverse effects of FOLFIRINOX are severe. For example, the incidence of 3/4 grade neutrophil decrease in patients receiving FOLFIRINOX is significantly higher than those with Gem (45.7% VS. 21%, P < 0.001). Thus, it is difficult for many patients to receive standard FOLFIRINOX and benefit from the protocol. Therefore, the investigators aim to explore an improvement program of FOLFIRINOX, hoping to better benefit patients.
S-1 is a new oral fluoropyrimidine derivative in which tegafur is combined with two 5-chloro-2, 4-dihydroxypyridine modulators and oteracil potassium, a potentiator of 5-ﬂuorouracil's (5-FU's) antitumor activity that also decreases gastrointestinal toxicity. Combination chemotherapy with Gem and S-1 is reportedly well tolerated and benefits patients with advanced PDAC. Based on the results of the GEST study, S-1 is found to be non-inferior to Gem in patients' survival.
Therefore, in this study, the investigators replaced 5-FU and leucovorin in the FOLFIRINOX regimen with oral S-1, forming a SIRIOX regimen to treat patients with advanced pancreatic cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of the Combination of S-1, Irinotecan and Oxaliplatin (SIRIOX) in Treating Patients With Advanced Inoperable or Metastatic Pancreatic Cancer|
|Estimated Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: SIRIOX regimen
5-FU and leucovorin in the FOLFIRINOX regimen were replaced with oral S-1, forming the SIRIOX regimen(S1 plus irinotecan and oxaliplatin)
Patients are planned to receive the SIRIOX regimen including S-1 (BSA < 1.2m2, 40 mg/day; BSA = 1.2~1.4 m2, 60 mg/day; BSA = 1.4~1.6 m2, 80 mg/day; BSA > 1.6 m2, 100 mg/day; oral twice daily on days 1-7, days 15-21）of every cycle.
• 28 days a cycle.
Patients are planned to receive the SIRIOX regimen including Oxaliplatin (OXA, 85 mg/m2; d1,d15) of every cycle.
• 28 days a cycle
Patients are planned to receive the SIRIOX regimen including Irinotecan (IRI, 180mg/m2; day 1,day 15) of every cycle.
• 28 days a cycle
- progression free survival (PFS) [ Time Frame: 6 weeks (1.5 cycle) ]The time from the beginning of randomization to the earliest date of confirmation of tumor progression or the patient death for any reason. If the above criteria are not reached, the date of the last evaluation will be used.
- objective response rate (ORR) [ Time Frame: 6 weeks (1.5 cycle) ]
The proportion of patients whose tumors shrink to a certain amount for a certain period of time and include cases of complete response (CR) and partial response (PR). Calculated as: (CR cases + PR cases) / FAS × 100 (%); FAS (full analysis set) refers to the case of qualified patients, administered more than one case.
Tumor remission rates are calculated according to the RECIST guidelines (version 1.1)
- overall survival (OS) [ Time Frame: through study completion, an average of 18 months ]The time from the beginning of randomization to the earliest date of confirmation of the patient death for any reason.
- Toxicity evaluated according to the Common Terminology Criteria Adverse Events [ Time Frame: every week ]Toxicity is evaluated according to the Common Terminology Criteria Adverse Events Version3.0,CTCAEv3.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403101
|Contact: Xianjun Yu, M.D., Ph.D.||+86 21 firstname.lastname@example.org|
|Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University||Not yet recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Xianjun Yu, M.D., Ph.D. +86 21 64175590 email@example.com|
|Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China||Recruiting|
|Shanghai, China, 200032|
|Contact: Xian-Jun Yu, M.D., Ph.D. +86-21-64175590 firstname.lastname@example.org|
|Contact: Liang Liu, M.D., Ph.D. +86-21-64175590 email@example.com|
|Principal Investigator: Xian-Jun Yu, M.D., Ph.D.|
|Study Chair:||Xianjun Yu, M.D., Ph.D.||270 Dong An Road, Shanghai 200032, China|