Adenocarcinoma of the Esophagus or Esophagogastric JunctionPhase 2PALAESTRANCT02241499
Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.
A Phase 2 study testing Radiation therapy and Oxaliplatin and fluorouracil. in people with Adenocarcinoma of the Esophagus or Esophagogastric Junction, run by Lund University Hospital at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Esophagus or Esophagogastric Junction
- What is being tested?
- Radiation therapy and Oxaliplatin and fluorouracil.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2014to May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Radiation therapy, Oxaliplatin and fluorouracil.
- Keywords
- Digestive System Diseases, Esophageal cancer, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Endoscopic response, Fluorouracil, Metabolic response, Oxaliplatin, Radiotherapy
- Medical subject headings
- Adenocarcinoma Of Esophagus, Digestive System Diseases, Esophageal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
Radiotherapy at a dose of 4 Gy will be given to a total dose of 20 Gy, treatment duration 5 days.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Radiation therapy; Drug: Oxaliplatin and fluorouracil. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
Endoscopic response of the primary tumor.
Measured: Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the Esophagus or Esophagogastric JunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Borg, MD, Principal investigator, Lund University Hospital, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241499
- Sponsor's protocol ID
- DBG01
- Acronym
- PALAESTRA
- Status last verified
- Feb 2020
- First submitted
- 8 Sep 2014
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Short-course Hypofractionated Radiotherapy Followed by Chemotherapy in Adenocarcinoma of the Esophagus or Esophagogastric Junction Trial - a Phase II Clinical Trial Protocol.
- ClinicalTrials.gov ID
- NCT02241499
- Acronym / sponsor ID
- PALAESTRA / DBG01
- Keywords
- Digestive System Diseases, Esophageal cancer, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Endoscopic response, Fluorouracil, Metabolic response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy and chemotherapy (oxaliplatin and fluorouracil). | Experimental | Radiation: Radiation therapy, Drug: Oxaliplatin and fluorouracil.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyRadiotherapy at a dose of 4 Gy will be given to a total dose of 20 Gy, treatment duration 5 days. | Radiation | Radiotherapy and chemotherapy (oxaliplatin and fluorouracil). |
| Oxaliplatin and fluorouracil.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. | Drug | Radiotherapy and chemotherapy (oxaliplatin and fluorouracil). |
Primary outcome
Improvement of dysphagia.
Time frame: 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.
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.
1 secondary outcome
Endoscopic response of the primary tumor.
Time frame: Endoscopy will be performed before start of treatment, and within 4 weeks after end of radiotherapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Borg, MD principal investigator
Lund University Hospital, Department of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation therapy and Oxaliplatin and fluorouracil. in people with Adenocarcinoma of the Esophagus or Esophagogastric Junction, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of dysphagia. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.