Esophageal carcinoma
Conditions
Interventions
Trade Name: Herceptin
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
Trade Name: Pertuzumab
Pharmaceutical Form: Solution for infusion
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically proven adenocarcinoma of the intrathoracic esophagus or gastro esophageal junction. - HER2-positive tumor defined as either IHC 3+ or IHC 2+, the latter in combination with ISH+, as assessed by the sponsor-designated central laboratory on a primary tumor biopsy. - Surgical resectable (=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - A tumour the epicenter of which in the stomach is greater than 5 cm of the GE junction or those within 5 cm of the GE junction without extension in the oesophagus are classified as gastric cancer. - Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated in situ carcinoma of the cervix, or malignancy more than 5 years prior to enrollment. - Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation. - Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment. - Previous chemotherapy, radiotherapy, treatment with an anti-HER2 antibody or with small molecule HER2 inhibitors. - Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before randomization. - Pulmonary fibrosis and/or severely impaired lung function. - Pre-existing motor or sensory neurotoxicity greater than WHO grade 1. - Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine. - Dementia or altered mental status that would prohibit the understanding and giving of informed consent - Inadequate caloric- and/or fluid intake
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: assess the feasibility of preoperative treatment with pertuzumab and trastuzumab combined with preoperative chemoradiation (carboplatin, paclitaxel and radiation) in terms of withdrawal rate from surgery;Secondary Objective: • To assess toxicities of pertuzumab and trastuzumab alone and in combination with chemoradiation. • To assess post-operative complications. • To assess pathological response. • To assess R0 resection rate. • To assess pharmacokinetics of pertuzumab and trastuzumab. ;Primary end point(s): Feasibility of preoperative treatment with pertuzumab and trastuzumab combined with preoperative chemoradiation (carboplatin, paclitaxel and radiation) in terms of withdrawal rate from surgery;Timepoint(s) of evaluation of this end point: Continues during treatment and Follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To assess toxicities of pertuzumab and trastuzumab alone and in combination with chemoradiation. • To assess post-operative complications. • To assess pathological response. • To assess R0 resection rate. • To assess pharmacokinetics of pertuzumab and trastuzumab ;Timepoint(s) of evaluation of this end point: Continues during treatment and Follow up | — |
Countries
Netherlands
Contacts
Public ContactEva van Daalen
Academic Medical Center
Outcome results
None listed