Multicentre, open phase II trial to evaluate safety and efficacy of a perioperative chemotherapy with docetaxel, cisplatin and capecitabin in patients suffering from adenocarcinoma of the stomach, gastroesophageal junction or distal esophagus.

Phase 1

Active, not recruiting

• Conditions: Gastric cancer is the second most frequent cause of cancer-related deaths worldwide. In 2002 934,000 gastric carcinomas were diagnosed and 700,000 deaths related to this disease were reported. The five-year survival rate of resectable gastric carcinomas correlates with the pathologic tumor and nodal stage with lymph node metastases being the main prognostic factor. Tumors which reach beyond the submucosa are associated with a five-year survival rate between 20 and 40%.

• Registration Number: EUCTR2008-001849-26-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-29
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

-signed informed consent
-age between 18 and 75 years
-primary diagnosis of histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or distal one third of the esophagus
-stage II or III, i.e. TNM-stage of T3-4, N0-3, M0 or T2, N1-3, M0 or T1, N2, M0 (according to the clinical stages uT3-4 NX M0, uT1-2N+M0)
-intended curative resection decided by an experienced surgeon
-Karnofsky-index >= 70%
-in women of child-bearing age: negative pregnancy blood test at screening, but no earlier than 72 hours before onset of chemotherapy
-adequate hematologic, liver and renal function: neutrophils >=1,5 x 10^9/L; platelets>= 100 x 10^9/L; hemoglobin > 10 g/dl, calculated creatinin-clearance (Cockroft-Gault) > 60ml/min; total bilirubine <= 1,0 x UNL, AST ALT <= 1,5 x UNL; AP <= 2,5 x UNL
-complete staging within 3 weeks before onset of chemotherapy (chest CT, abdomen CT, endosonoscopy, gastroscopy)
-ability to meet the deadlines and comply with protocol
-
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-previous therapy of a carcinoma of the gastroesophageal junction (surgery, chemo- or radiotherapy)
-diagnosis of a previous malignant disease in the 5 years preceding the study participation that was healed by more than surgical means (apart from carcinoma in situ of the cervix uteri and cured skin cancer other than melanoma)
-known deficiency of dihydropyrimidine-dehydrogenase (DPD)
-known contraindication as to the chemotherapeutics applied in the trial
-existence of distant metastases
-known serious diseases or other concomitant diseases which could affect the participation, e.g.:
*unstable cardiac disease: symptomatic cardiac insufficiency, angina pectoris, ventricular arrhythmia in spite of medical treatment, myocardial infarction or cardiopulmonar resuscitation during 6 months preceding trial participation
*active infection requiring systemic therapy or uncontrolled infection
*interstitial lung disease (e.g. pneumonitis, fibrosis) or suspicion of interstitial lung disease in chest X-ray or CT
*active inflammatory bowel disease or other bowel diseases causing chronic diarrhea (defined as more than 4 defecations per day)
*neurologic or psychiatric disorders including dementia, epilepsia or untreated, symptomatic metastases of the central nervous system
*limited hearing
-existence of an upper intestinal stenosis impairing the swallowing of comminuted tablets
-existence of an acute or chronic systemic infection
-preceding ileus during 30 days before trial participation
-pregnant or breast-feeding women or women of child-bearing age and men, who do not comply in using a highly effective method of contraception for the duration of the trial and three months after the last infusion
-any other condition making trial participation an inadequate harm to the patient according to the investigator´s opinion
-simultaneous participation in another clinical trial or earlier participation in this trial
-treatment with another antitumor therapy or simultaneous radiotherapy
-simultaneous treatment with sorivudine or chemically related drugs as brivudine
-symptomatic peripheral neuropathy of NCI-CTCAE>=2
-hypersensibility against the drugs used in this trial or their galenic ingredients or against 5-FU
-persons institutionalized by court order (AMG § 40 Abs. 1 Nr. 4)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified