Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma
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Purpose
The aim of this study is the evaluate the feasibility and safety of chemotherapy induction treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in the treatment of patients with non-metastatic esophageal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: 5-FU Drug: Cisplatin Drug: Taxotere Biological: Cetuximab Radiation: Radiation during chemoradio-immunotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study |
- Response rate [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Percentage of complete remissions and resection rate [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Occurrence of toxicities [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- Evaluation of Quality of Life [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment Arm
Chemo induction therapy followed by chemoradiotherapy and surgical resection or definitive radiotherapy
|
Drug: 5-FU
750 mg/m2/d C.I. i.v.d1-5, d29-33 and 300 mg/m2/d C.I. i.v. on the days of radiotherapy
Drug: Cisplatin
15 mg/m2/d i.v. d1-5, d29-33
Other Name: Cisplatin
Drug: Taxotere
75 mg/m2/d i.v. d1 and d29, 15 mg/m2/d i.v. on d57, d64, d71 and d78
Other Name: Docetaxel
Biological: Cetuximab
Cetuximab: 400 mg/m2 i.v. d1; 250mg/m2 weekly d8 through d85
Other Name: Erbitux
Radiation: Radiation during chemoradio-immunotherapy
39.6 Gy total dose
|
Detailed Description:
Patients with a locoregional carcinoma of the esophagus or gastro-esophageal junction have a low survival prognosis following surgical resection. In studies published to date no positive effect upon overall survival could be demonstrated for preoperative chemotherapy or chemoradiotherapy. However, patients with a complete remission following preoperative therapy show prolonged survival.
This study design is based upon decreasing primary tumour and preventing oder delaying micrometastases by means of a chemo induction therapy, increasing R0 resection rates and preventing local recurrence by means of preoperative chemoradiotherapy, increasing the radiosensitivity of tumour cells through treatment combination with cetuximab, surgical resection of the locoregional primary tumour or definitive radiochemotherapy in case the primary tumour is inoperable.
The aim of this study is therefore to evaluate the feasibility and safety of a 3-staged therapy approach including an EGFR antibody in the treatment of patients with potentially resectable esophageal cancer, as well as the evaluation of objective response rates to this preoperative therapy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed informed consent
- histologically confirmed esophageal cancer (squamous cell carcinoma)
- measurable, non-metastatic disease (uT1-4)
- no previous cancer therapy (chemotherapy, radiotherapy or resection)
- life expectancy > 3 months
- age > 18 years
- WHO Status ≤ 2
- negative pregnancy test for women of child-bearing potential, and use of adequate contraception
- hematological status: neutrophiles ≥ 1,5x10E9/L, thrombocytes ≥ 100x10E9/L
- adequate renal function: serum creatinine ≤ 1,5 x ULN
- adequate liver function: alkaline phosphatase < 2,5 x ULN, total bilirubin < 1,5 x ULN
Exclusion Criteria:
- pregnant or nursing women
- women of child-bearing potential without adequate contraception
- concomitant anti-tumoral therapy except study mandated procedures
- cervical esophageal cancer or diagnosis of metastases
- participation in other clinical trials within the last 30 days
- history of malignant disease within the last 5 years
- peripheral neuropathy (NCI CTC ≥ grade 1)
- concurrent active and serious non-malignant diseases: uncontrolled heart insufficiency, angina pectoris, hypertension or arrhythmias, liver disease, significant neurological or psychiatric conditions
- active infections
Contacts and Locations| Austria | |
| Landeskrankenhaus Feldkirch | |
| Feldkirch, Austria, A-6806 | |
| Universitätsklinikum Graz | |
| Graz, Austria, A-8036 | |
| Universitätsklinik Innsbruck | |
| Innsbruck, Austria, A-6020 | |
| A.ö. Landeskrankenhaus Leoben | |
| Leoben, Austria, A-8700 | |
| Universitaetsklinik f. Innere Medizin III | |
| Salzburg, Austria, A-5020 | |
| Krankenhaus Barmherzige Brueder St. Veit a.d. Glan | |
| St. Veit/ Glan, Austria, A-9300 | |
| Klinikum Kreuzschwestern Wels GmbH | |
| Wels, Austria, A-4600 | |
| Principal Investigator: | Wolfgang Eisterer, Prof. Dr. | Medizinische Universitaet Innsbruck |
More Information
No publications provided
| Responsible Party: | Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie |
| ClinicalTrials.gov Identifier: | NCT00735345 History of Changes |
| Other Study ID Numbers: | AGMT_ECa, EudraCT Nr. 2008-001016-21 |
| Study First Received: | August 13, 2008 |
| Last Updated: | October 6, 2010 |
| Health Authority: | Austria: Ethikkommission Austria: Federal Office for Safety in Health Care |
Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
|
Esophageal cancer Pre-operative Chemo-immunotherapy Radiochemo-immunotherapy |
EGFR Radiosensitivity Resection |
Additional relevant MeSH terms:
|
Carcinoma Esophageal Diseases Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Head and Neck Neoplasms Docetaxel Cetuximab Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013