Study to Evaluate Safety and Efficacy of Perioperative Chemotherapy With Docetaxel, Cisplatin and Capecitabine (DCX) in Patients With Gastro-esophageal Cancer (DCXAIOCHARITE)
Recruitment status was Active, not recruiting
Drug: Docetaxel, Cisplatin, Capecitabine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Open Lable Phase II Study to Evaluate the Safety and Efficacy of a Perioperative Chemotherapy With Docetaxel, Cisplatin and Capecitabine in Patients With Gastric Adenocarcinoma, Adenocarcinoma of the Gastro-esophageal Junction or the Distal Esophagus|
- R0-resection rate [ Time Frame: After 3 cycles of preoperative chemotherapy (3 month) ] [ Designated as safety issue: No ]
- Remission rate according to diagnostic imaging techniques [ Time Frame: After 3 cycles of preoperative chemotherapy (3 month) ] [ Designated as safety issue: No ]
- Pathological remission rate [ Time Frame: After 3 cycles of preoperative chemotherapy (3 month) ] [ Designated as safety issue: No ]
- Operative and postoperative complication rate [ Time Frame: Within 30 days after surgery ] [ Designated as safety issue: Yes ]
- Resectability rate [ Time Frame: After 3 cycles of preoperative chemotherapy (3 month) ] [ Designated as safety issue: No ]
- Rate of local recurrences and metastasis [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- 30-day mortality [ Time Frame: After date of surgery ] [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Overall survival rate [ Time Frame: 1,2,3 and 5 years ] [ Designated as safety issue: No ]
- Event free survival rate [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Drug: Docetaxel, Cisplatin, Capecitabine
3 preoperative cycles with Docetaxel 75 mg/m² d1 Cisplatin 60 mg/m² d1 Capecitabine 1875 mg/m²/day d1-14 repeated every 3 weeks
followed by resection
and 3 postoperative cycles with Docetaxel 75 mg/m² d1 Cisplatin 60 mg/m² d1 Capecitabine 1875 mg/m²/day d1-14 repeated every 3 weeks.
Perioperative chemotherapy has been shown to significantly improve the R0 resection rate, the disease free survival and the overall survival in patients with adenocarcinoma of the distal esophagus, the gastro-esophageal junction and the stomach. Therefore perioperative chemotherapy is the new therapeutic standard (Cunningham NEJM 2006, MRC, Lancet 2002, Boige ASCO 2007). The best evaluated regime is the combination of Epirubicin, Cisplatin and 5-FU (ECF) (Cunningham, NEJM 2007). Cisplatin and 5-FU seem to be the most important components forming the backbone of this regime (Boige ASCO 2007).
Docetaxel is a new and highly active agent in gastric cancer. In a randomized phase II study the dual combination of Docetaxel and 5-FU seemed to show similar activity as ECF, administered as first line palliative treatment (Thuss-Patience, JCO, 2005). The three drug combination Docetaxel, Cisplatin, 5-FU has significantly superior efficacy than a combination of Cisplatin und 5-FU, superior quality of life and significantly superior overall survival (Van Cutsem, JCO 2007).
It has been shown that Capecitabine the oral prodrug of 5-FU is similarly active as 5-FU and can replace intravenous 5-FU in combination with Cisplatin in the treatment of gastric cancer. Capecitabine therefore is FDA approved for gastric cancer (Cunningham, ASCO 2006, Kang ASCO 2006).
It seems reasonable to optimize perioperative chemotherapy by including modern chemotherapeutics. The old standard ECF may be improved by integrating Docetaxel und Capecitabine. By adding Docetaxel to the Cisplatin / flouropyrimidin backbone the efficacy of the regime may be improved. The replacement of 5-FU by Capecitabine may improve patients´ convenience and possibly effectiveness of the combination. Therefore the 3 drug combination of Docetaxel, Cisplatin, Capecitabin (DCX) seems to be a highly promising regime regarding effectiveness and convenience.
In this study patients with adenocarcinoma of the stomach, gastro-esophageal junction or the distal esophagus who seem operable with curative intent according to oncological and surgical assessment are treated with 3 preoperative cycles of DCX followed by surgical resection, followed by 3 postoperative cycles of DCX.
The first application of study medication has to be within 21 days of tumour assessment. There will be 3 preoperative cycles every 3 weeks. The experimental perioperative regime evaluated in this study will be Docetaxel/Cisplatin/Capecitabine DCX (75/ 60/ 1875 mg/m2).The operation will be performed 3 to 6 weeks after the end of the third preoperative chemotherapy cycle (counted from day 21 of cycle 3).
Postoperative chemotherapy will start within 6 - 12 weeks after the operation. 3 weeks after the end of the last chemotherapy the final investigation (end of study visit) will be done.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865982
|HELIOS-Klinik Bad Saarow|
|Bad Saarow, Germany|
|Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Charite Campus Virchow Klinikum|
|Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charite Campus Benjamin-Franklin|
|Klinik für Hämatologie, Onkologie und Tumorimmunologie, Charite Campus Buch|
|Klinik für Innere Medizin Abteilung Hämatologie/Onkologie, Städtisches Klinikum Dessau|
|Universitätsklinik und Poliklinik für Innere Medizin IV, Martin Luther Universität Halle-Wittenberg|
|Halle (Saale), Germany|
|II. Medizinische Klinik und Poliklinik, Universitätsklinikum Schleswig-Holstein Campus Kiel|
|Internistische Onkologie/ Hämatologie, Städtisches Krankenhaus St. Georg|
|3. Medizinische Klinik, Onkologisches Zentrum, Universitätsklinikum Mannheim|
|Study Chair:||Peter Thuss-Patience, Dr. med.||Charite University, Berlin, Germany|