Status:
RECRUITING
TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Esophageal Cancer
Esophageal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Despite treatment according to the CROSS-regimen, median overall survival is less than four years (2.3 QALYs). The burden of disease is within the highest category (0.71 to 1.0). Also, no targeted tre...
Eligibility Criteria
Inclusion
- 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:
- Neutrophils ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin ≥ 5.6 mmol
- Total bilirubin ≤ 1.5 x upper normal limit
- Creatinine clearance (Cockroft) \> 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
- 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 \< 1,5L) precluding major surgery.
- 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 despite consultation of a dietician and/or tube feeding.
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Active infection requiring systemic therapy which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment.
- Evidence of acute or chronic infection with hepatitis B, C or HIV.
- History of prior allogeneic stem cell or solid organ transplantation.
- Pre-existing motor or sensory neurotoxicity greater than or equal to CTC AE grade 2.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2037
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT05188313
Start Date
March 9 2022
End Date
February 1 2037
Last Update
June 24 2022
Active Locations (1)
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1
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ