Esophageal Cancer
Conditions
Interventions
The intervention consists of adding trastuzumab and pertuzumab to standard
treatment (CROSS regimen). The standard treatment consists of chemotherapy
(carboplatin and paclitaxel) and radiation follo
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histologically proven adenocarcinoma of the esophagus or gastroesophageal junction, T1N+M0; or T2-T4a N0 or N+ M0). - HER2-positive tumor defined as either IHC 3+ or IHC 2+, the latter in combination with ISH+, as assessed by the local laboratory on a primary tumor biopsy. HER2 status needs to be confirmed by the central laboratory, but does not affect start of treatment. - Surgical resectability, as determined during multidisciplinary meeting. Tumors that cannot be passed with an endoscope for endoscopic ultrasound are eligible if all other criteria are fulfilled. - If the tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction. - Age >= 18. - ECOG performance status 0 or 1 (cf. Appendix A). - Adequate hematological, renal and hepatic functions defined as: o Neutrophils >= 1.5 x 109/L o Platelets >= 100 x 109/L o Hemoglobin >= 5.6 mmol o Total bilirubin 60 ml/min - Adequate left ventricular ejection fraction defined as an LVEF of >=55% determined by transthoracic echocardiography or MUGA. - Written, voluntary informed consent - Patients must be accessible to follow up and management in the treatment center
Exclusion criteria
Exclusion criteria: - T1N0 tumors or in situ carcinoma. - Past (within 5 years) or current history of malignancy other than entry diagnosis which has a worse expected prognosis than the current esophageal cancer. - Previous chemotherapy, radiotherapy, treatment with an anti-HER2 antibody or with small molecule HER2 inhibitors for esophageal cancer or for any other cancer within 6 months of diagnosis of esophageal cancer. - Previous radiation to the mediastinum precluding full dose radiation of the currently present esophageal tumor. - Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. - Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation. - Not willing to use highly effective methods of contraception (per institutional standard) during treatment (male or female) and for 6 months after the end of treatment. - Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery. - Pulmonary fibrosis and/or severely impaired lung function (FEV1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are quality of life adjusted survival, progression-free survival and pathological response, safety and quality of life. Survival measures are determined up to a maximum follow-up period of 5.5 years. Quality of life is assessed before initiation of treatment and then every three months in the first year, every 6 months in the second year and annually thereafter. Chemotherapy side effects are determined immediately after the end of treatment and serious side effects are reported immediately. Pathological response is assessed by the pathologist according to the so-called Mandard criteria immediately after surgery. | — |
Countries
Netherlands
Outcome results
None listed