A Phase 3 interventional study of cetuximab and cisplatin in Adenocarcinoma of the Gastroesophageal Junction and Esophageal Cancer, sponsored by Swiss Group for Clinical Cancer Research. Completed at 57 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-10-20.
Sponsored by Swiss Group for Clinical Cancer Research · Phase 3, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays and to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving radiation therapy together with chemotherapy is more effective with or without cetuximab in treating patients with esophageal cancer.
PURPOSE: This randomized phase III trial is studying giving radiation therapy together with chemotherapy, with or without cetuximab, followed by surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to center, histology (adenocarcinoma vs squamous cell carcinoma), primary tumor (T2 vs T3-4), and gender (male vs female). Patients are randomized to 1 of 2 treatment arms.
Arm A:
After completion of study therapy, patients are followed up at 1 (arm B) or 6 (arm A) months, every 3 months for 3 years, and then every 6 months for 2 years.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 297 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Swiss Group for Clinical Cancer Research is the lead sponsor of 107 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Meets the following criteria:
Resectable, locally advanced disease as determined by the combination of CT scan, endoluminal ultrasound (EUS), PET scan, and a multidisciplinary team discussion
T2, N1-3; T3, any N; or T4a, any N (if technically resectable with curative intent [R0] as decided by a multidisciplinary team discussion)
PATIENT CHARACTERISTICS:
No severe or uncontrolled cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
All patients in the experimental arm will be given additional immunotherapy (cetuximab) during cycles 1 and 2, during RT and after surgery.
Biological: cetuximab · Drug: cisplatin · Drug: docetaxel · Procedure: adjuvant therapy · Procedure: neoadjuvant therapy
Standard therapy without immunotherapy (cetuximab).
Drug: cisplatin · Drug: docetaxel
Loading dose 400 mg/m2 2h infusion Weekly: 250 mg/m2 1h infusion
Also known as: Erbitux
* Cisplatin 75 mg/m2 1h infusion d1, 22 * Cisplatin 25 mg/m2 1h infusion weekly x5
* Docetaxel 75 mg/m2 1h infusion d1, 22 * Docetaxel 20 mg/m2 1/2h infusion weekly x5
Also known as: Taxotere or generic product
During the adjuvant phase, all infusions, given every two weeks, will be at a dose of 500mg/m².
During the neoadjuvant phase, the first infusion of cetuximab should be at a dose of 400 mg/m² administered over a period of 2 hours and all subsequent infusions, given weekly, should be of 250 mg/m² over a period of 1 hour, unless any infusion related reaction was observed at a previous infusion. (The maximum infusion rate is 10 mg/min, corresponding to 2 mL/min ready-to-use solution.
Progression-free survival (PFS)
time from randomization to one of the following events, whichever comes first: * Tumor progression at any time (progression of primary tumor or local lymph nodes, appearance of new lesions) * Recurrence at local, regional or distant site after surgery * Death from any cause
Time frame: time from randomization to a defined event.
Progression-free survival after surgery
Time frame: from date of surgery to an event as defined in PFS.
Adverse events according to CTCAE version 4.0 and major postoperative complications
Time frame: during treatment and follow-up period.
Pathological remission
Time frame: Assessed according to the tumor regression model of Mandard
Overall survival
Time frame: time from trial randomization to the date of death from any cause
Time to locoregional failure after R0 resection
Time frame: from date of surgery to date of first documented loco-regional failure
Time to systemic failure after R0 resection
Time frame: from date of surgery to date of first documented systemic failure
In-hospital mortality
Time frame: occurring after surgery but while the patient remains in hospital
Time to progression (TTP)
Time frame: Time to progression is defined as 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 due to tumor
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Swiss Group for Clinical Cancer Research