Study to Evaluate Safety and Efficacy of Perioperative Chemotherapy With Docetaxel, Cisplatin and Capecitabine (DCX) in Patients With Gastro-esophageal Cancer (DCXAIOCHARITE)

August 4, 2011 updated by: Charite University, Berlin, Germany

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

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 (Docetaxel, Cisplatin, Capecitabine) followed by surgical resection, followed by 3 postoperative cycles of DCX.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Saarow, Germany
        • HELIOS-Klinik Bad Saarow
      • Berlin, Germany
        • Klinik für Hämatologie, Onkologie und Tumorimmunologie, Charite Campus Buch
      • Berlin, Germany
        • Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charite Campus Benjamin-Franklin
      • Berlin, Germany
        • Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Charite Campus Virchow Klinikum
      • Dessau, Germany
        • Klinik für Innere Medizin Abteilung Hämatologie/Onkologie, Städtisches Klinikum Dessau
      • Halle (Saale), Germany
        • Universitätsklinik und Poliklinik für Innere Medizin IV, Martin Luther Universität Halle-Wittenberg
      • Kiel, Germany
        • II. Medizinische Klinik und Poliklinik, Universitätsklinikum Schleswig-Holstein Campus Kiel
      • Leipzig, Germany
        • Internistische Onkologie/ Hämatologie, Städtisches Krankenhaus St. Georg
      • Mannheim, Germany
        • 3. Medizinische Klinik, Onkologisches Zentrum, Universitätsklinikum Mannheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed and dated consent
  • Age between minimum 18 and maximum 75 years
  • Primary diagnosis of histologically proven adenocarcinoma of the stomach, the gastro-esophageal junction or an adenocarcinoma of the lower third of the esophagus
  • Stage II-III, which is in TNM-staging: T3-4, N0-3, M0 or T2, N1-3, M0 or T1, N2, M0. (equivalent to clinical staging uT3-4NXM0, uT1-2N+M0)
  • Intended curative resection according to evaluation of an experienced surgeon
  • Karnofsky-performance-index > 70%
  • Negative pregnancy blood test at screening but not earlier than 72 hours prior to start of chemotherapy for women with child bearing potential
  • Adequate haematologic function and liver and renal function: neutrophils > 1,5 x 109/L; thrombocytes > 100 x 109/L; haemoglobin > 10 g/dl, creatinine clearance > 60 ml/min (calculated according to Cockroft and Gault), total bilirubin < 1,0 x UNL; AST and ALT < 1,5 x UNL, AP < 2,5 x UNL
  • Complete staging within 3 weeks prior to start of treatment (CT-scan of thorax and abdomen, endosonography, gastroscopy)
  • Ability to keep appointments and follow the study protocol
  • By CT-scan, endoscopy or endosonography measurable or evaluable disease

Exclusion Criteria:

  • Former therapy of gastro-esophageal cancer (operation, chemo- or radiotherapy)
  • Diagnosis of another cancer in the last 5 years prior to study entry which has not been cured by operation only (exception in-situ-carcinoma of the cervix or cured non-melanomatose skin cancer)
  • Known dihydropyrimidine-dehydrogenase (DPD)-deficiency
  • Known contraindication to the planned chemotherapeutics
  • Presence of distant metastases

  • Anamnestic known serious disease or other concomitant diseases that affect participation in this study, such as:

    • Instable cardiac disease: symptomatic heart failure, symptomatic coronary artery disease, ventricular cardiac arrhythmia not well controlled with medication, myocardial infarction or resuscitation within 6 month before study
    • Active infection necessitating systemic therapy or uncontrolled infection
    • Interstitial lung diseases (for example: pneumonitis or fibrosis of the lung) and indication for interstitial lung disease in chest x-ray or CT-scan respectively
    • Active inflammatory bowel disease or other bowel diseases which provoke chronic diarrhea (defined as > 4 bowel movements per day)
    • Neurological or psychiatric disease including dementia, epilepsy or untreated, symptomatic brain metastases
    • Limited hearing ability
  • Presence of upper GI obstruction, leading to inability to swallow ground tablets
  • Presence of acute or chronic systemic infection
  • Presence of a bowel obstruction within the last 30 days
  • Pregnant or lactating women or women with child bearing potential and men without adequate contraception (high effective contraception, defined as Pearl Index < 1) like birth control pill, hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), realized sterilization or sexual abstinence during the study and at least for 3 months after the last infusion
  • Any other situation which may lead to an unacceptable high risk for the patient, when he participates in the study
  • Parallel treatment in another clinical study or prior participation in this study
  • Treatment with any other therapy against the tumor or any parallel radiation
  • Parallel treatment with Sorivudine or an chemically related substance like for example Brivudin
  • Symptomatic peripheral neuropathy NCI-CTCAE degree > 2
  • Intolerance to the study medication or their galencic ingredients or against 5-FU
  • Detention in a psychiatric unit or imprisonment (AMG §40 Abs. 1 Nr. 4)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
R0-resection rate
Time Frame: After 3 cycles of preoperative chemotherapy (3 month)
After 3 cycles of preoperative chemotherapy (3 month)

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Overall survival
Remission rate according to diagnostic imaging techniques
Time Frame: After 3 cycles of preoperative chemotherapy (3 month)
After 3 cycles of preoperative chemotherapy (3 month)
Pathological remission rate
Time Frame: After 3 cycles of preoperative chemotherapy (3 month)
After 3 cycles of preoperative chemotherapy (3 month)
Operative and postoperative complication rate
Time Frame: Within 30 days after surgery
Within 30 days after surgery
Resectability rate
Time Frame: After 3 cycles of preoperative chemotherapy (3 month)
After 3 cycles of preoperative chemotherapy (3 month)
Rate of local recurrences and metastasis
30-day mortality
Time Frame: After date of surgery
After date of surgery
Overall survival rate
Time Frame: 1,2,3 and 5 years
1,2,3 and 5 years
Event free survival rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Sanofi
Roche Pharma AG

Investigators

  • Study Chair: Peter Thuss-Patience, Dr. med., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

March 19, 2009

First Posted (Estimate)

March 20, 2009

Study Record Updates

Last Update Posted (Estimate)

August 5, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eudract-CT-2008-001849-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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