CancerPALLUNCT06150027
Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers
A study testing Systematic referral to a palliative care team in people with Cancer and Emergencies, run by Centre Leon Berard at 6 sites in France.
Trial summary
This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers. In the standard arm, patients will be managed regardless of their PALLIA-10 score, following conventional strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Emergencies
- What is being tested?
- Systematic referral to a palliative care team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 6 sitesFrance
- Study dates
- 12 Sep 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male or female ≥ 18 years at the day of consenting to the study;
- Confirmed diagnosis of any type of solid or haematology tumours, with or without Current oncological treatment, such as chemotherapy, immunotherapy, targeted therapy, etc;
- Unscheduled admission in a French Regional Comprehensive Anti-Cancer Centre due to an acute, unpredictable, intercurrent event related to cancer, its therapies or a comorbidity;
- Patient for whom disease is considered as not curable;
- PALLIA-10 Score > 3/10;
- Willingness and ability to comply with the study requirements;
- Signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrolment;
- Patient must be covered by a medical insurance.
Who cannot join
- Patient without consciousness, unable to provide a written informed consent (context of emergency);
- Patient treated with a curative intent;
- Previous randomization in this clinical study;
- Patients already followed-up by a palliative care team;
- Life expectancy shorter than 1 month, as per the emergency units' staff judgement.
- Any medical or psychosocial condition that would compromise the patient's compliance to the study visits or would likely interfere with the completion of Patient-Reported Outcomes.
- Patients under tutorship or curatorship.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Léon Bérard
Lyon, 69008
ICM Val d'Aurelle
Montpellier, 34090
Institut Curie - Paris
Paris, 75005
Institut Curie - Saint Cloud
Saint-Cloud, 92210
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: A Randomized Comparative Prospective Multicenter Study of the Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers
This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers.
In the standard arm, patients will be managed regardless of their PALLIA-10 score, following conventional strategy. In the experimental arm, patients will be systematically referred to a palliative care team.
Read the detailed description
This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers.
All patients undergoing a visit in the daily emergency room of a participating center and who need for palliative management (PALLIA 10 score > 3/10) will be considered for inclusion in the PALLU study. After signing the written informed consent, patients will be randomized (1:1 ratio) in one of the following arms:
- Standard arm : conventional strategy; patients will be managed regardless of their PALLIA-10 score. The need for additional care, including palliative care, will be assessed by the team in charge of the patient, as per routine practice.
- Experimental arm : experimental strategy; patients will be systematically referred to a palliative care team.
Randomization will be stratified according to the investigation center and pre-existing follow-up by pain management team.
The difference of intervention will lie in the fact that patients will be referred or not to a palliative care team but patients from the standard arm may receive palliative care as deemed necessary by the medical oncology team. In this case, the content of palliative care for patients included in both groups will be identical.
The end of the study will be the Last Patient Last Visit (LPLV), defined as the date of the 12-month visit of the last patient still alive or when the 192nd death has occurred, whichever occurs first.
- Conditions
- Cancer, Emergencies
- Being tested
- Systematic referral to a palliative care team
- Keywords
- Early palliative care, Cancer, Aggressiveness of care, Emergency
- Medical subject headings
- Neoplasms, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic referral to a palliative care teamOther
Patients randomized in the experimental arm will be systematically referred to a palliative care team.
A follow-up in palliative care will be initiated for all within a maximum of 15 days after the date of randomization.
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Conventional strategy: patients will be managed regardless of their PALLIA-10 score. The need for additional care, including palliative care, will be assessed by the team in charge of the patient, as per routine practice. |
| Experimental | Experimental | Experimental strategy: patients will be systematically referred to a palliative care team. Receives: Other: Systematic referral to a palliative care team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggressiveness of care near the end of life
Percentage and number of patients who meet at least one of the following criteria :
- More than 1 hospitalization in the last 30 days of life;
- More than 1 visit in an emergency unit in the last 30 days of life;
- More than 14 days in hospital in the last 30 days of life;
- Hospitalization in a resuscitation unit in the last 30 days of life;
- Treatment with systemic anticancer therapy in the last 14 days of life;
- New systemic anticancer therapy regimen starting in the last 30 days of life;
- Patients dying in an acute care setting.
Measured: From date of randomization until the date of death from any cause, assessed up to 30 months
Secondary outcomes (13)
More than 1 hospitalization in the last 30 days of life
Percentage and number of patients having more than 1 hospitalization in the last 30 days of life
Measured: From date of randomization until the date of death from any cause, assessed up to 48 months
More than 1 visit in an emergency unit in the last 30 days of life
Percentage and number of patients having more than 1 visit in an emergency unit in the last 30 days of life
Measured: From date of randomization until the date of death from any cause, assessed up to 30 months
More than 14 days in hospital in the last 30 days of life
Percentage and number of patients having more than 14 days in hospital in the last 30 days of life
Measured: From date of randomization until the date of death from any cause, assessed up to 30 months
Hospitalization in a resuscitation unit in the last 30 days of life
Percentage and number of patients having a hospitalization in a resuscitation unit in the last 30 days of life
Measured: From date of randomization until the date of death from any cause, assessed up to 30 months
Treatment with chemotherapy in the last 14 days of life
Percentage and number of patients having a treatment with chemotherapy in the last 14 days of life
Measured: From date of randomization until the date of death from any cause, assessed up to 30 months
New chemotherapy regimen starting in the last 30 days of life
Percentage and number of patients having a new chemotherapy regimen starting in the last 30 days of life
Measured: From date of randomization until the date of death from any cause, assessed up to 30 months
Death in an acute care setting
Percentage and number of patients dying in an acute care setting
Measured: At the date of death from any cause, assessed up to 30 months
Medical resources mobilized in terms of palliative care
Medical resources mobilized in terms of palliative care (psychologist, social worker, nutritional counselling, etc.) will be described for the interventional group in terms of number and percentage of patients with at least one consultation with each specialist
Measured: From date of randomization until the date of death from any cause, assessed up to 30 months
Health-related quality of life using the FACT-G7 cancer specific questionnaire
The total score ranges from 0 and 28, with a higher score indicates better quality of life. Scores will be described per randomized group at each measurement time (inclusion,3 months and 6 months) using same criteria as for other quantitative variables (number of observations, mean, standard deviation, median, minimum and maximum values).
Measured: At inclusion, 3 months, 6 months, 9 months and at 12 months
Health-related quality of life using the HADS
One score is generated for anxiety and one score for depression on a 0 to 21 points, with a higher score indicates higher level of trouble. Scores will be described per randomized group at each measurement time (inclusion,3 months and 6 months) using same criteria as for other quantitative variables (number of observations, mean, standard deviation, median, minimum and maximum values). Number and percentage of patients without anxiety or depression trouble (i.e. with a score of 7 or lower), moderate trouble (score between 8 to 10) and severe trouble (score of 11 or more) will be reported.
Measured: At inclusion, 3 months, 6 months, 9 months and at 12 months
Symptoms of cancer disease using the Edmonton Symptoms Assessment System (ESAS) symptom scores
Pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing and patient-specific symptoms are each described on a scale ranging from 0 to 10 (10 being the worst). The mean change in symptoms will be estimated from baseline and at each follow-up time. The ESAS symptom scores will be calculated according to the authors' recommendations and described per randomized group at each time point by mean, standard deviation, median and range.
Measured: From date of randomization until the date of death from any cause, assessed up to 30 months
Place of death
Hospital and type of unit or home will be described per randomized group
Measured: At the date of death from any cause, assessed up to 30 months
Overall Survival
Defined as the time from the date of inclusion to the date of death due to any cause.
Measured: At the date of death from any cause, assessed up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start12 Sep 2024
- Primary completionApr 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization (ratio 1:1) will be stratified according to the investigation center and pre-existing follow-up by pain management team.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle CHVETZOFF, MD,PhD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150027
- Sponsor's protocol ID
- ET22-175
- Acronym
- PALLU
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the patient information sheet and informed consent form, the participants do not agree to share their individual personal data.
Publications
Chvetzoff G, Anota A, Perrier L, Gautier J, Bouleuc C, Moreau P, Thomaso M, Le Divenah G, Henry A, Francois M, Massiani MA, Mateus C, Merad M, Bissuel L, Baudry AS, Christophe V, Russias B, Perol D. Systematic referral to palliative care in patients attending dedicated emergency units from French comprehensive anticancer centres: the prospective multicentre randomised comparative clinical trial PALLU. BMJ Open. 2025 Aug 24;15(8):e101299. doi: 10.1136/bmjopen-2025-101299.
PubMed 40850913
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Prospective Multicenter Study of the Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers
- ClinicalTrials.gov ID
- NCT06150027
- Acronym / sponsor ID
- PALLU / ET22-175
- Conditions
- Cancer, Emergencies
- Keywords
- Early palliative care, Cancer, Aggressiveness of care, Emergency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 29 Nov 2023 (actual)
- 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.
This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers.
In the standard arm, patients will be managed regardless of their PALLIA-10 score, following conventional strategy. In the experimental arm, patients will be systematically referred to a palliative care team.
Detailed description
This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers.
All patients undergoing a visit in the daily emergency room of a participating center and who need for palliative management (PALLIA 10 score > 3/10) will be considered for inclusion in the PALLU study. After signing the written informed consent, patients will be randomized (1:1 ratio) in one of the following arms:
- Standard arm : conventional strategy; patients will be managed regardless of their PALLIA-10 score. The need for additional care, including palliative care, will be assessed by the team in charge of the patient, as per routine practice.
- Experimental arm : experimental strategy; patients will be systematically referred to a palliative care team.
Randomization will be stratified according to the investigation center and pre-existing follow-up by pain management team.
The difference of intervention will lie in the fact that patients will be referred or not to a palliative care team but patients from the standard arm may receive palliative care as deemed necessary by the medical oncology team. In this case, the content of palliative care for patients included in both groups will be identical.
The end of the study will be the Last Patient Last Visit (LPLV), defined as the date of the 12-month visit of the last patient still alive or when the 192nd death has occurred, whichever occurs first.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization (ratio 1:1) will be stratified according to the investigation center and pre-existing follow-up by pain management team.
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Conventional strategy: patients will be managed regardless of their PALLIA-10 score. The need for additional care, including palliative care, will be assessed by the team in charge of the patient, as per routine practice. |
| Experimental | Experimental | Other: Systematic referral to a palliative care teamExperimental strategy: patients will be systematically referred to a palliative care team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female ≥ 18 years at the day of consenting to the study;
- Confirmed diagnosis of any type of solid or haematology tumours, with or without Current oncological treatment, such as chemotherapy, immunotherapy, targeted therapy, etc;
- Unscheduled admission in a French Regional Comprehensive Anti-Cancer Centre due to an acute, unpredictable, intercurrent event related to cancer, its therapies or a comorbidity;
- Patient for whom disease is considered as not curable;
- PALLIA-10 Score > 3/10;
Key exclusion criteria (7 listed)
- Patient without consciousness, unable to provide a written informed consent (context of emergency);
- Patient treated with a curative intent;
- Previous randomization in this clinical study;
- Patients already followed-up by a palliative care team;
- Life expectancy shorter than 1 month, as per the emergency units' staff judgement.
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 |
|---|---|---|
| Systematic referral to a palliative care teamPatients randomized in the experimental arm will be systematically referred to a palliative care team. A follow-up in palliative care will be initiated for all within a maximum of 15 days after the date of randomization. | Other | Experimental |
Primary outcome
Aggressiveness of care near the end of life
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 months
Percentage and number of patients who meet at least one of the following criteria : * More than 1 hospitalization in the last 30 days of life; * More than 1 visit in an emergency unit in the last 30 days of life; * More than 14 days in hospital in the last 30 days of life; * Hospitalization in a resuscitation unit in the last 30 days of life; * Treatment with systemic anticancer therapy in the last 14 days of life; * New systemic anticancer therapy regimen starting in the last 30 days of life; * Patients dying in an acute care setting.
13 secondary outcomes
More than 1 hospitalization in the last 30 days of life
Time frame: From date of randomization until the date of death from any cause, assessed up to 48 months
More than 1 visit in an emergency unit in the last 30 days of life
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 months
More than 14 days in hospital in the last 30 days of life
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 months
Hospitalization in a resuscitation unit in the last 30 days of life
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 months
Treatment with chemotherapy in the last 14 days of life
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 months
New chemotherapy regimen starting in the last 30 days of life
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 months
Death in an acute care setting
Time frame: At the date of death from any cause, assessed up to 30 months
Medical resources mobilized in terms of palliative care
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 months
Health-related quality of life using the FACT-G7 cancer specific questionnaire
Time frame: At inclusion, 3 months, 6 months, 9 months and at 12 months
Health-related quality of life using the HADS
Time frame: At inclusion, 3 months, 6 months, 9 months and at 12 months
Symptoms of cancer disease using the Edmonton Symptoms Assessment System (ESAS) symptom scores
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 months
Place of death
Time frame: At the date of death from any cause, assessed up to 30 months
Overall Survival
Time frame: At the date of death from any cause, assessed up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 40850913Chvetzoff G, Anota A, Perrier L, Gautier J, Bouleuc C, Moreau P, Thomaso M, Le Divenah G, Henry A, Francois M, Massiani MA, Mateus C, Merad M, Bissuel L, Baudry AS, Christophe V, Russias B, Perol D. Systematic referral to palliative care in patients attending dedicated emergency units from French comprehensive anticancer centres: the prospective multicentre randomised comparative clinical trial PALLU. BMJ Open. 2025 Aug 24;15(8):e101299. doi: 10.1136/bmjopen-2025-101299.
- Individual participant dataSharing planned: No. In the patient information sheet and informed consent form, the participants do not agree to share their individual personal data.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Gisèle CHVETZOFF, MD,PhD principal investigator
Centre Leon Berard
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic referral to a palliative care team in people with Cancer and Emergencies, run by Centre Leon Berard at 6 sites in France.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Aggressiveness of care near the end of life (time frame: From date of randomization until the date of death from any cause, assessed up to 30 months). 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 NCT06150027, which also lists 1 linked publication.
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 17 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.