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

NCT00865982 | Unknown Phase 2 DMC

• 1 other identifier: Eudract-CT-2008-001849-26
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Gastric Cancer; Esophageal Cancer

Keywords

adenocarcinoma of the stomach, gastro-esophageal junction or distal esophagus; gastric cancer; esophageal cancer; gastro-esophageal junction; docetaxel; capecitabine; cisplatin; perioperative chemotherapy

Outcome Measures

Primary Outcomes (1)

• R0-resection rate

  After 3 cycles of preoperative chemotherapy (3 month)

Secondary Outcomes (10)

• Remission rate according to diagnostic imaging techniques

  After 3 cycles of preoperative chemotherapy (3 month)

• Pathological remission rate

  After 3 cycles of preoperative chemotherapy (3 month)

• Operative and postoperative complication rate

  Within 30 days after surgery

• Resectability rate

  After 3 cycles of preoperative chemotherapy (3 month)

• Rate of local recurrences and metastasis

Interventions

Docetaxel, Cisplatin, Capecitabine DRUG

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Roche Pharma AG: collaborator
• Sanofi: collaborator

Study Sites (9)

HELIOS-Klinik Bad Saarow

Bad Saarow, Germany

Location

Klinik für Hämatologie, Onkologie und Tumorimmunologie, Charite Campus Buch

Berlin, Germany

Location

Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charite Campus Benjamin-Franklin

Berlin, Germany

Location

Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Charite Campus Virchow Klinikum

Berlin, Germany

Location

Klinik für Innere Medizin Abteilung Hämatologie/Onkologie, Städtisches Klinikum Dessau

Dessau, Germany

Location

Universitätsklinik und Poliklinik für Innere Medizin IV, Martin Luther Universität Halle-Wittenberg

Halle, Germany

Location

II. Medizinische Klinik und Poliklinik, Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Location

Internistische Onkologie/ Hämatologie, Städtisches Krankenhaus St. Georg

Leipzig, Germany

Location

3. Medizinische Klinik, Onkologisches Zentrum, Universitätsklinikum Mannheim

Mannheim, Germany

Location

Related Publications (1)

• Thuss-Patience PC, Hofheinz RD, Arnold D, Florschutz A, Daum S, Kretzschmar A, Mantovani-Loffler L, Bichev D, Breithaupt K, Kneba M, Schumacher G, Glanemann M, Schlattmann P, Reichardt P, Gahn B. Perioperative chemotherapy with docetaxel, cisplatin and capecitabine (DCX) in gastro-oesophageal adenocarcinoma: a phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)dagger. Ann Oncol. 2012 Nov;23(11):2827-2834. doi: 10.1093/annonc/mds129. Epub 2012 Jun 24.

  PMID: 22734012 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Interventions

Docetaxel; Cisplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Peter Thuss-Patience, Dr. med.

  Charite University, Berlin, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: August 5, 2011

Record last verified: 2011-08

Locations

DE (9)