Clinical trial · Interventional
Study to Evaluate Safety and Efficacy of Perioperative Chemotherapy With Docetaxel, Cisplatin and Capecitabine (DCX) in Patients With Gastro-esophageal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel, Cisplatin, Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- R0-resection rate
- timeFrame
- After 3 cycles of preoperative chemotherapy (3 month)
Secondary outcomes (10)
- measure
- Remission rate according to diagnostic imaging techniques
- timeFrame
- After 3 cycles of preoperative chemotherapy (3 month)
- measure
- Pathological remission rate
- timeFrame
- After 3 cycles of preoperative chemotherapy (3 month)
- measure
- Operative and postoperative complication rate
- timeFrame
- Within 30 days after surgery
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDThuss-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