Tumor in Upper Gastrointestinal Canal or Patients With Colorectal CancerALLANNCT02246725
Observational Study of Early Contact With Palliative Care Unit for Patients Receiving First Line Palliative Chemotherapy With Cancer in Upper Gastrointestinal Canal, or Second Line Palliative Chemotherapy in Patients With Colorectal Cancer - an Open, Randomised Investigator Initiated Trial.
An observational study of Tumor in Upper Gastrointestinal Canal or Patients With Colorectal Cancer, run by Lund University Hospital at 1 site in Sweden.
Trial summary
In this trial, patients with cancer in the upper gastrointestinal canal who are going to receive first line palliative chemotherapy and patients with colorectal cancer who are going to receive second line palliative chemotherapy will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor in Upper Gastrointestinal Canal or Patients With Colorectal Cancer
- What is being tested?
- Contact with palliative care unit.
- How many people
- 108 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2014to 31 Aug 2025
- Phase
- Observational
- 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
Study population: Patients with tumor in esophagus, stomach, pancreas liver-biliary passage receiving first line palliative chemotherapy, or patients with colorectal cancer receiving second line palliative chemotherapy.
Who may be able to join
- Patients with tumor in upper gastrointestinal canal, who is going to start treatment with first line palliative chemotherapy
- Patients with colorectal cancer, who is going to start treatment with second line palliative chemotherapy
- Signed written informed concent
Who cannot join
- Patients with neuroendocrine tumor
- Patients with already ongoing chemotherapy
- Patients with already established contact with palliative care unit
Trial locations and contacts
1 site in 1 country.
About this study
In this trial, patients with cancer in the upper gastrointestinal canal who are going to receive first line palliative chemotherapy and patients with colorectal cancer who are going to receive second line palliative chemotherapy will be included. Participating patients will be randomized between early contact with a palliative care unit, or contact with a palliative care unit when needed. The objectives with the trial is to investigate if an early establishment with a palliative care unit will have a positive impact on the patients quality of life, this also applies for the nearest relative, survival, and if a difference in numbers of chemotherapy cycles can be detected.
- Being tested
- Contact with palliative care unit.
- Keywords
- Colorectal Neoplasms, Depression, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Palliative chemotherapy, Palliative care, Palliative treatment, Quality of life, Quality of life for relatives, Survival
- Medical subject headings
- Colorectal Neoplasms, Depression, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact with palliative care unit.Other
| Study group | Role | What they receive |
|---|---|---|
| Contact with palliative care unit versus contact when needed. | Not described Receives: Other: Contact with palliative care unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life, such as pain, anxiety.
Evaluation will be performed by different quality of life forms sent to the patient every 6th week, and by telephone contact with a study nurse every 6th week until patients death. The same also applies for the patients nearest relative; quality of life forms will be sent every 12th week for additional 1 year.
Measured: At baseline, every 6th week until death (approximately 1 year). The patients relative will be followed similarly until patients death and then every 12th week for 1 year.
Secondary outcomes (1)
Survival
Measured: Approximately 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startOct 2014
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tumor in Upper Gastrointestinal Canal or Patients With Colorectal CancerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikael Segerlantz, MD, PhD, Principal investigator, Palliative Care and Advanced Home Health Care, Primary Health Care Skåne, Sankt lars väg 81, SE-221 85 LUND, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246725
- Sponsor's protocol ID
- MS01
- Acronym
- ALLAN
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2014
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Bojesson A, Brun E, Eberhard J, Segerlantz M. The ALLAN trial: impact of early home-based palliative care on emergency care and hospitalisation in advanced gastrointestinal cancer patients. Br J Cancer. 2026 Jul;135(2):248-254. doi: 10.1038/s41416-026-03444-8. Epub 2026 Apr 24.
PubMed 42032200Bojesson A, Brun E, Eberhard J, Segerlantz M. Quality of life for patients with advanced gastrointestinal cancer randomised to early specialised home-based palliative care: the ALLAN trial. Br J Cancer. 2024 Sep;131(4):729-736. doi: 10.1038/s41416-024-02764-x. Epub 2024 Jul 1.
PubMed 38951699
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Early Contact With Palliative Care Unit for Patients Receiving First Line Palliative Chemotherapy With Cancer in Upper Gastrointestinal Canal, or Second Line Palliative Chemotherapy in Patients With Colorectal Cancer - an Open, Randomised Investigator Initiated Trial.
- ClinicalTrials.gov ID
- NCT02246725
- Acronym / sponsor ID
- ALLAN / MS01
- Keywords
- Colorectal Neoplasms, Depression, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 23 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 cancer in the upper gastrointestinal canal who are going to receive first line palliative chemotherapy and patients with colorectal cancer who are going to receive second line palliative chemotherapy will be included. Participating patients will be randomized between early contact with a palliative care unit, or contact with a palliative care unit when needed. The objectives with the trial is to investigate if an early establishment with a palliative care unit will have a positive impact on the patients quality of life, this also applies for the nearest relative, survival, and if a difference in numbers of chemotherapy cycles can be detected.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contact with palliative care unit versus contact when needed. | – | Other: Contact with palliative care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tumor in esophagus, stomach, pancreas liver-biliary passage receiving first line palliative chemotherapy, or patients with colorectal cancer receiving second line palliative chemotherapy.
Key inclusion criteria (3 listed)
- Patients with tumor in upper gastrointestinal canal, who is going to start treatment with first line palliative chemotherapy
- Patients with colorectal cancer, who is going to start treatment with second line palliative chemotherapy
- Signed written informed concent
Key exclusion criteria (3 listed)
- Patients with neuroendocrine tumor
- Patients with already ongoing chemotherapy
- Patients with already established contact with palliative care unit
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 |
|---|---|---|
| Contact with palliative care unit. | Other | Contact with palliative care unit versus contact when needed. |
Primary outcome
Quality of Life, such as pain, anxiety.
Time frame: At baseline, every 6th week until death (approximately 1 year). The patients relative will be followed similarly until patients death and then every 12th week for 1 year.
Evaluation will be performed by different quality of life forms sent to the patient every 6th week, and by telephone contact with a study nurse every 6th week until patients death. The same also applies for the patients nearest relative; quality of life forms will be sent every 12th week for additional 1 year.
1 secondary outcome
Survival
Time frame: Approximately 12 months.
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 12 Sep 2025.
- Derived from this study: PubMed 42032200Bojesson A, Brun E, Eberhard J, Segerlantz M. The ALLAN trial: impact of early home-based palliative care on emergency care and hospitalisation in advanced gastrointestinal cancer patients. Br J Cancer. 2026 Jul;135(2):248-254. doi: 10.1038/s41416-026-03444-8. Epub 2026 Apr 24.
- Derived from this study: PubMed 38951699Bojesson A, Brun E, Eberhard J, Segerlantz M. Quality of life for patients with advanced gastrointestinal cancer randomised to early specialised home-based palliative care: the ALLAN trial. Br J Cancer. 2024 Sep;131(4):729-736. doi: 10.1038/s41416-024-02764-x. Epub 2024 Jul 1.
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.
Mikael Segerlantz, MD, PhD principal investigator
Palliative Care and Advanced Home Health Care, Primary Health Care Skåne, Sankt lars väg 81, SE-221 85 LUND, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor in Upper Gastrointestinal Canal or Patients With Colorectal Cancer, 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 3 inclusion and 3 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 12 Sep 2025. 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.
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?
Quality of Life, such as pain, anxiety. (time frame: At baseline, every 6th week until death (approximately 1 year). The patients relative will be followed similarly until patients death and then every 12th week for 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02246725, which also lists 2 linked publications.
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 12 Sep 2025.