Adenocarcinoma of the Esophagus or Esophagogastric Junction Clinical Trial
— PALAESTRAOfficial title:
Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.
| NCT number | NCT02241499 |
| Other study ID # | DBG01 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | October 2014 |
| Est. completion date | May 2019 |
| Verified date | February 2020 |
| Source | Lund University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | May 2019 |
| Est. primary completion date | May 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Lund University Hospital, Department of Oncology | Lund |
| Lead Sponsor | Collaborator |
|---|---|
| Lund University Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Metabolic response | Metabolic response will be evaluated before start of treatment, and within 4 weeks after end of chemotherapy. | ||
| Primary | 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. | |
| Secondary | Endoscopic response of the primary tumor. | Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy. |