Locally advanced esophageal carcinoma. MedDRA version: 20.0 Level: LLT Classification code 10041824 Term: Squamous cell carcinoma of esophagus System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10056092 Term: Adenocarcinoma of oesophagus System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Erbitux
Product Name: Cetuximab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923
Sponsors
Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung SAKK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed squamous cell carcinoma (including basaloid-squamous cell and adenosquamous carcinoma) or adenocarcinoma of the thoracic esophagus or the esophagogastric junction (from 5 cm below the entrance of the esophagus into the thorax to the gastric cardia (=esophagogastric junction), types I and II according to the Siewert staging system). Resectable, locally advanced disease (the stage is determined by the combination of CT scan, EUS and PET and by a multidisciplinary team discussion) Age: 18-75 years Health status: WHO performance status (PS) = 1 Patient is considered operable (appropriate organ functions) Adequate renal function: creatinine clearance > 60 mL/min, calculated according to the formula of Cockroft-Gault Adequate pulmonary function: FEV1 > 1.5L or, if =65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: Stage T1 Nany M0 Stage T2 N0 M0 Stage T4a due to infiltration of the tracheo-bronchial tree or organ involvement which cannot be operated on with curative intent (R0) as decided by a multidisciplinary team discussion Stage T4b Distant metastasis (M1) Cervical esophageal carcinoma and tumors involving the first 5 cm of the thoracic esophagus Airway infiltration in case of tumors at or above the tracheal bifurcation Peritoneal carcinomatosis in case of adenocarcinomas infiltrating the gastric cardia (i.e. esophagogastric junction carcinoma Siewert type I or II) Previous malignancies within five years or concomitant malignancies, except: nonmelanomatous skin cancer or adequately treated in situ cervical cancer Prior chemotherapy or prior RT to the chest Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias) Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent and answering the questions of the EQ-5D questionnaire and HEA forms (EQ-5D questionnaire and HEA forms applicable for Swiss centers and for patients who gave consent for the HEA only) Active uncontrolled infection Serious underlying medical condition (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, active autoimmune disease) Preexisting peripheral neuropathy (> grade 1) Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry Definite contraindications for the use of corticosteroids and antihistamines as premedication Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): · Progression-free survival after surgery (PFS-OP) · Adverse events according to CTCAE version 4.0 and major postoperative complications · Pathological remission (=TRG 1+2) · R0-resection · Overall survival · Time to loco-regional failure after R0-resection · Time to systemic failure after R0-resection · Feasibility of the therapy: Completion of therapy · In-hospital mortality · Compliance with radiotherapy standards ;Timepoint(s) of evaluation of this end point: Please refer to protocol section 13. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the efficacy of neoadjuvant radiochemotherapy (RCT) combined with immunotherapy followed by adjuvant immunotherapy compared with the same schedule without immunotherapy (neoadjuvant and adjuvant).;Secondary Objective: Compare the toxicity of the two therapy arms and determine patterns of failure overall and with regard to histology; further to evaluate economic aspects in a subproject and to perform a radiotherapy quality assurance program.;Primary end point(s): Progression-free survival (PFS); Timepoint(s) of evaluation of this end point: Time from randomization to one of the following events, whichever comes first: · Tumor progression at any time · Recurrence at local, regional or distant site after surgery · Death from any cause | — |
Countries
Austria, Germany, Hungary, Switzerland
Contacts
Public ContactClinical Project Manager
Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung SAKK
Outcome results
None listed