Study evaluating the effects of chemotherapy on incurable cancer of the esophagus or stomach

Phase 1

• Conditions: Esophagogastric adenocarcinoma; MedDRA version: 18.1Level: PTClassification code 10062878Term: Gastrooesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000127-24-DK
• Lead Sponsor: Rigshospitalet, Department of Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-27
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 98

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 < 2.5 x ULN and alkaline phosphatase < 5 x ULN and bilirubin Haematology blood counts: Leucocytes >/=3 x 109/l, platelets >/=100 x 109/l.
Cardiac function: NYHA class < II
Patients must be able to take capecitabine tablets whole, or dissolved in water.
Patients on warfarin must be able and willing to convert to lowmolecular-weight heparin.
Ability to consent to, comply with and tolerate treatment, assessment and follow-up as laid out in this protocol.
Written informed consent is required and must be signed by both patient and investigator (or a delegate).
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 49
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 49

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.

Study & Design

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