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In this trial, patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent will be included. Primary objective is to determine the rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil. The rate of improvement of dysphagia is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy and chemotherapy (oxaliplatin and fluorouracil). | Experimental | Radiotherapy (5 x 4 Gy) will be given. After completion of radiotherapy, 4 cycles of chemotherapy will be administered, cycle length 14 days. Each patient will receive oxaliplatin as infusion at a dose of 85 mg/m2, followed by a bolus injection of fluorouracil at a dose of 400 mg/m2, and a long time infusion (44 hours) of fluorouracil at a dose of 2 400 mg/m2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation therapy | Radiation | Radiotherapy at a dose of 4 Gy will be given to a total dose of 20 Gy, treatment duration 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of dysphagia. | The rate of improvement in dysphagia after palliative short course hypofractionated radiotherapy (5 x 4 Gy) followed by chemotherapy consisting of oxaliplatin and fluorouracil is evaluated by a 5 graded dysphagia score, and a positive change of at least 1 score is considered to be an approvement. | The grade of dysphagia is evaluated before start of treatment, 1-4 weeks after end of radiotherapy, then until local intervention or death, average of 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic response of the primary tumor. | Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic response | Metabolic response will be evaluated before start of treatment, and within 4 weeks after end of chemotherapy. |
Inclusion Criteria:
Patients with histologically proven adenocarcinoma of the esophagus or esophagogastric junction noneligible for surgery or chemoradiation with curative intent
Any T, N and M
Age: 18 years or older
WHO performance status ≤ 2
Life expectancy > 3 months
Dysphagia score > 0
Adequate laboratory findings: hemoglobin > 90 g/L, absolute neutrophil count
Fertile men and women must use effective means of contraception
Signed written informed concent
The patient must be able to comply with the protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Borg, MD | Lund University Hospital, Department of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lund University Hospital, Department of Oncology | Lund | 221 85 | Sweden |
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| Oxaliplatin and fluorouracil. | Drug | Oxaliplatin at a dose of 85 mg/m2 and will be given on day 1, infusion (44 hours) of fluorouracil will be given for 4 cycles, cycle length 14 days. |
|
| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
| D004066 | Digestive System Diseases |
| D004938 | Esophageal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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