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In patients with esophageal cancer, treatment with curative intent can be given to medically fit patients without distant metastases. It may consist of chemoradiotherapy or surgery alone or in combination. Surgery in combination with chemotherapy is another option. For patients who are not medically fit for surgery or with unresectable invasion in adjacent structures the only alternative with curative intent is, with current knowledge, definitive chemoradiotherapy. In the current study the investigators aim to improve prognosis for patients not suitable for surgery. Patients receive treatment with conventional chemoradiotherapy (oxaliplatin, fluorouracil and radiotherapy) with the addition of a more recently developed drug, an antibody called cetuximab.
Patients are treated with three cycles of oxaliplatin and fluorouracil 750 mg/m2/24 hours, day 1-5. Each cycle lasts for 21 days. Oxaliplatin is given with 130 mg/m2 in the first cycle and in cycle 2 and 3 which are administered concomitant with radiotherapy the dose is reduced to 85 mg/m2.
A loading dose of cetuximab 400 mg/m2 is given one week before the start of radiotherapy, and thereafter 250 mg/m2 is given weekly during the course of radiotherapy.
Concomitant with chemotherapy radiotherapy to a total dose of 50 Gy is given (2 Gy once daily in 25 fractions, 5 days a week) with a photon beam linear accelerator.
After treatment patients are followed every 6 months for three years with clinical examination and a CT-scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab | Experimental | Cetuximab is administered once a week. The initial dose is 400 mg/m2 body surface area. First Cetuximab infusion should start day 15 in cycle 1.The subsequent weekly doses are 250 mg/m2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local tumour Control | Local tumour control will be measured with a computed tomography | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Tumour respons evaluation with CT-scan | 3 years |
| Toxicity | Toxicity will be measured with the Common Toxicity Criteria Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriella A von Döbeln, MD | Karolinska University Hospital | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 2, 2021 | |
| Reset | Sep 30, 2021 | |
| Release | Oct 3, 2021 | |
| Reset | Nov 1, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 2, 2021 | Sep 30, 2021 | |||
| Oct 3, 2021 |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 3 years |
| Patterns of relapse | First site of recurrence will be evaluated with CT, supplemented with biopsy if indicated | 3 years |
| Overall and disease-free survival | Tumour respons evaluation with CT scan | 3 years |
| Quality of life | Quality of life assessed with the EORTC QLQ-C30 questionnaire. | 3 years |
| Nov 1, 2021 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |