Clinical trial · Interventional
Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.
NCT02241499CI-TRIAL-00043700PALAESTRAcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Esophagus or Esophagogastric Junction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin and fluorouracil. | Drug | — | UNRESOLVED |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy and chemotherapy (oxaliplatin and fluorouracil).
- description
- 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.
- interventionNames
- Radiation: Radiation therapy
- Drug: Oxaliplatin and fluorouracil.
Primary outcomes (1)
- measure
- Improvement of dysphagia.
- timeFrame
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 1.0 10 9/L, platelets ≥ 75 x 10 9/L, bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 5 x ULN, creatinine ≤ 1.5 x ULN * 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: * Prior treatment with self-expanding metal stent (SEMS), radiotherapy or chemotherapy for the present disease * Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months) unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure * Severe pulmonary disease e.g. pulmonary fibrosis * Symptomatic peripheral neuropathy greater than grade 1 (CTCAE v. 4.0) * Known hypersensitivity to any contents of the study drugs * Pregnancy ( positive pregnancy test) and/or breast feeding * Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
References
Publications (0)
Data not yet available
No reference posted for this study.