Phase
Condition
Gastric Cancer
Stomach Cancer
Digestive System Neoplasms
Treatment
Docetaxel
Capecitabine
radiotherapy of gastric cancer
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- TNM 8th ed stage IB-IIIC gastric cancer (histologically proven); tumour bulk has to bein the stomach but may involve gastro-oesophageal junction
- WHO < 2
- Age ≥ 18 yrs
- Resectable adenocarcinoma of the stomach or gastro-oesophageal junction
- No prior abdominal radiotherapy
- Haematology: Hb ≥5.0 mmol/l; leukocytes≥3.0x109/l, neutrophils ≥1.5x109/l,thrombocytes ≥100x109/l
- Renal function: serum creatinine ≤1.25x ULN, creatinine clearance ≥ 50 ml/min (calculated by Cockcroft and Gault formula) Liver function: total bilirubin ≤1.5x ULN,alkaline phosphatase and ASAT/ALAT ≤ 3x ULN
- At staging laparoscopy (mandatory) obtained biopsies of suspected peritoneal lesionsand/or substantial free peritoneal fluid if any should be pathologically proven tumornegative
- Written informed consent
- Expected adequacy of follow-up
- Caloric intake≥1500 kcal/day, verified by a dietician before registration.
- if caloric intake is < 1500 kcal/day or if bodyweight has decreased > 10% over thelast 6 months or > 5% over the last month, dietary intervention such as oralnutritional support or enteral tube feeding is mandatory
Exclusion
Exclusion Criteria:
- T1N0 disease (assessed by endoscopic ultrasound)
- Distant metastases
- Inoperable patients; due to technical surgery-related factors or general condition
- Previous malignancy, except adequately treated non-melanoma skin cancer or in-situcancer of the cervix uteri; in case of a previous other malignancy with a disease-freeperiod≥5 years, inclusion can be accepted after consultation of the principalinvestigator
- Solitary functioning kidney that will be within the radiation field
- Major surgery within 4 weeks prior to study treatment start, or lack of completerecovery from the effects of major surgery
- Uncontrolled (bacterial) infections
- Significant concomitant diseases preventing the safe administration of study drugs orlikely to interfere with study assessments
- Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias
- Continuous use of immunosuppressive agents equivalent to >10 mg daily prednison
- Concurrent use of the antiviral agent sorivudine or chemically related analogues, suchas brivudine
- Neurotoxicity > CTC grade 1
- Pregnancy or breast feeding
- Patients (M/F) with reproductive potential not implementing adequate contraceptivemeasures
- Gastric or gastro-esophageal stent within radiation field
Study Design
Connect with a study center
Medisch Centrum Leeuwarden
Leeuwarden, Friesland 8901BR
NetherlandsSite Not Available
Radiotherapeutisch Instituut Friesland
Leeuwarden, Friesland 8934AD
NetherlandsSite Not Available
Gelre Ziekenhuizen
Apeldoorn, Gelderland 7334DZ
NetherlandsSite Not Available
Gelre Ziekenhuizen
Zutphen, Gelderland 7207AE
NetherlandsSite Not Available
Zuyderland Medisch Centrum
Sittard-Geleen, Limburg 6162 BG
NetherlandsSite Not Available
Viecuri Medisch Centrum
Venlo, Limburg 5912 BL
NetherlandsSite Not Available
Elkerliek
Deurne, Noord Brabant 5751 CB
NetherlandsSite Not Available
Catharina Ziekenhuis
Eindhoven, Noord Brabant 5602 ZA
NetherlandsSite Not Available
Maxima Medisch Centrum
Eindhoven, Noord Brabant 5631 BM
NetherlandsSite Not Available
St. Anna Zorggroep
Geldrop, Noord Brabant 5664 EH
NetherlandsSite Not Available
Elkerliek
Helmond, Noord Brabant 5707 HA
NetherlandsSite Not Available
Instituut Verbeeten
Tilburg, Noord Brabant 5022 GC
NetherlandsSite Not Available
Bernhoven
Uden, Noord Brabant 5406 PT
NetherlandsSite Not Available
Maxima Medisch Centrum
Veldhoven, Noord Brabant 5504 DB
NetherlandsSite Not Available
Spaarne Gasthuis
Hoofddorp, Noord-Holland 2000 AK
NetherlandsSite Not Available
Ziekenhuisgroep Twente
Almelo, Overijssel 7609 PP
NetherlandsSite Not Available
Deventer Ziekenhuis
Deventer, Overijssel 7416 SE
NetherlandsSite Not Available
Medisch Spectrum Twente
Enschede, Overijssel 7512 KZ
NetherlandsSite Not Available
Leids Universitair Medisch Centrum
Leiden, Zuid Holland 2333 ZA
NetherlandsSite Not Available
Reinier de Graaf Gasthuis
Delft, Zuid-Holland 2625 AD
NetherlandsSite Not Available
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ
NetherlandsSite Not Available
Academisch Medisch Centrum
Amsterdam, 1105AZ
NetherlandsSite Not Available
Netherlands Cancer Instituut
Amsterdam, 1066CX
NetherlandsSite Not Available
Rijnstate
Arnhem, 6815AD
NetherlandsSite Not Available
HAGA ziekenhuis
Den Haag, 2545AA
NetherlandsSite Not Available
Ziekenhuis Gelderse Vallei
Ede, 6716RP
NetherlandsSite Not Available
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsSite Not Available
Ziekenhuis St Antonius
Nieuwegein, 3435CM
NetherlandsSite Not Available
Elisabeth Tweesteden Ziekenhuis
Tilburg, 5022GC
NetherlandsSite Not Available
Universitair Medisch Centrum Utrecht
Utrecht, 3508 GA
NetherlandsSite Not Available
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