Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer (IPEC-GC)
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|ClinicalTrials.gov Identifier: NCT01830270|
Recruitment Status : Terminated
First Posted : April 12, 2013
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasms Oesophageal Junction Cancer Lower Oesophagus Cancer||Drug: Epirubicin Drug: Cisplatin Drug: Paclitaxel Procedure: gastric surgery||Phase 2|
The IPEC-GC study is a proof-of-concept study evaluating the efficacy and feasibility of PET regimen in 61 patients with lower oesophagus, oesophagus junction or gastric carcinoma.
Preoperative chemotherapy include eight weekly preoperative cycles of cisplatin (30mg/m2), epirubicin (50 mg/m2) and paclitaxel (90 mg/m2)with a break of one week without chemotherapy between cycle 4 and 5. Surgery is performed within 4-6 weeks after the end of the last cycle of chemotherapy. Primary endpoint of this trial is the curative resection rate (=R0). R0 must be higher than the 79% achieved in previous published studies. Response rate, histologic response rate (Becker score), progression-free survival, overall survival, impact of complete response in survival and dose-density are secondary endpoints. For an ancillary study, tumors (biopsies and operative specimens) and sera will be collected to identify biomarkers correlated with treatment efficacy.
This study is carried out by the Besançon University Hospital and were approved by the independent Est-II ethics committee and by the French National Authority for Health: AFSSAPS.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel (Intensified PET) in Patients With Locally Gastric Cancer : a Phase II Proof-of-concept Study.|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||May 2019|
|Experimental: PET regimen||
8 weekly cycles of chemotherapy with epirubicin (50 mg/m2)associated with cisplatin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.
8 weekly cycles of chemotherapy with cisplatin (30 mg/m2) associated with epirubicin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.
8 weekly cycles of chemotherapy with paclitaxel (90 mg/m2) associated with epirubicin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.
Procedure: gastric surgery
surgery will be scheduled within 4-6 weeks after the end of the last cycle of chemotherapy.
- curative resection rate [ Time Frame: an expected average of 4 weeks after surgery ]
- response rate [ Time Frame: between 2 and 4 weeks after the end of the last cycle of chemotherapy ]Response rate will be evaluated using RECIST v1.1 criteria (Response Evaluation Criteria in Solid Tumors ; Eisenhauer et al, 2009) by a CT-scan done between 2 and 4 weeks after the end of the last cycle to verify the absence of local or distant progression before surgery
- histologic response rate [ Time Frame: an expected average of 4 weeks after surgery ]Histologic response rate will be determined by the pathologist laboratory on operative specimens using Becker's score (Becker et al, 2003) to measure effects of neoadjuvant chemotherapy on gastric cancer.
- tolerance of the therapeutic association [ Time Frame: 1 week after each chemotherapy cycle ]Toxicities will be evaluated using Common Terminology Criteria for Adverse Events version 4.
- progression free survival [ Time Frame: from date to initiation of chemotherapy until the date of first documented progression (within 5 years after surgery) ]
- global survival [ Time Frame: from date to initiation of chemotherapy until the date of death for any cause (within 5 years after surgery) ]
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): NCT01830270
|University hospital of Besançon|
|Besançon, France, 25000|
|FNLCC center Georges François Leclerc|
|Dijon, France, 21000|
|Hospital of Belfort-Montbeliard|
|Montbeliard, France, 25200|