Esophagogastric adenocarcinoma MedDRA version: 18.1 Level: PT Classification code 10062878 Term: Gastrooesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: C
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Carboplatin
Current Sponsor code: C
Other descriptive name: CARBOPLATIN
Concentration unit: mg milligram
Sponsors
Rigshospitalet, Department of Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically verified, unresectable or metastatic, HER2-negative, adenocarcinoma of the esophagus or stomach. Patients with initially unresectable or metastatic disease, who, after a period of chemotherapy, are to be considered for surgery with curative intent, are eligible. Men or women less than 80 years of age. Performance status 0 or 1. Life expectancy >12 weeks. Adequate organ-function: Renal function: Calculated creatinine clearance > 60 ml/min by Cockcroft-Gault equation. Hepatic function: ALAT /=3 x 109/l, platelets >/=100 x 109/l. Cardiac function: NYHA class =65 years) yes F.1.3.1 Number of subjects for this age range 49
Exclusion criteria
Exclusion criteria: Prior chemotherapy for adenocarcinoma of the oesphagus or stomach if the chemotherapy-free interval is less than 6 months (prior concurrent hemoradiotherapy with curative intent less than 6 months before study entry is allowed) Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the oesphagus or stomach. Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry (prior concurrent chemoradiotherapy with curative intent less than 6 months before study entry is allowed) Prior cumulative dose of >300 mg/m2 of epirubicin Grade = 2 or more side-effects from previous chemotherapy. Inability to read and understand written Danish Concurrent prescription anti-neoplastic systemic therapy Another active cancer that would normally preclude chemotherapy for esophago-gastric adenocarcinoma Patients with known allergies to any of the drugs administered in this study Patients who are pregnant or breast-feeding, or might become pregnant within 6 months after the last dose of protocol-required therapy. Women of child-bearing potential who are not willing to use highly effective birth control methods during study and 6 months after the last dose of protocol-required therapy. Males who have a female partner of child-bearing potential and who are not willing to use highly effective birth control methods during study and 6 months after the last dose of protocol-required therapy. Males who have a pregnant partner and who are not willing to use a condom (to avoid exposure of a fetus to semen) during sexual activity while receiving protocol-required therapy and for 6 months after the last dose of protocol-required therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the 1-year survival rate associated with CTX;Secondary Objective: To estimate the progression-free survival associated with CTX To describe the 1-year survival rate associated with EOX To estimate overall survival for both study treatments To characterise the serious toxicities (grade 3-4 adverse events and SARs) in both treatments arms To describe the frequency of re-induction of CTX more than 6 months after CTX To describe further lines of anti-neoplastic treatment after study treatments To describe changes in the quality-of-life for patients receiving CTX;Primary end point(s): 1-year survival rate associated with CTX;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression-free-survival associated with CTX 1-year survival rate associated with EOX Overall survival associated with both study treatments. Grade 3 and 4 adverse events and Serious Adverse Reactions. Frequency of re-induction more than 6 months after CTX. Further lines of therapy after study treatments. Changes in self-reported symptoms and quality-Of-Life (QOL) for patients treated with CTX.;Timepoint(s) of evaluation of this end point: Variable | — |
Countries
Denmark
Contacts
Public ContactKlinisk Forskningsenhed
Rigshospitalet, Department of Oncology
Outcome results
None listed