Stage IV Lung CancerHIPPOCRATENCT02606149
Truthful Information on Chemotherapy and Its Impact on Chemotherapy at the End of Life
A study testing Truthful information on chemotherapy risks and Standard of information in people with Stage IV Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients with metastatic cancer have a substantial symptom burden and may receive aggressive care at the end of life. There is evidence that the use of chemotherapy near the end of life is not related to its likelihood of providing benefit and the overuse of aggressive anticancer therapies near the end of life may… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Lung Cancer
- What is being tested?
- Truthful information on chemotherapy risks and Standard of information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2016to 15 Oct 2020
- Phase
- Interventional
- 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
- stage IV lung cancer, histologically proven
- > 18 years old
- diagnosed during the last 8 weeks
- systemic therapy indicated
Who cannot join
- prior systemic therapy for metastatic disease
- comorbidity not compatible with the inclusion according to the investigator
- patient has not given its non-objection or not being able to give
- patient unaffiliated or not beneficiary of a social security scheme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Truthful Information Concerning Chemotherapy on Chemotherapy Prescription at the End of Life : a Randomized Controlled Study in Non-curable Lung Cancer Patients
Patients with metastatic cancer have a substantial symptom burden and may receive aggressive care at the end of life. There is evidence that the use of chemotherapy near the end of life is not related to its likelihood of providing benefit and the overuse of aggressive anticancer therapies near the end of life may result in more toxicity than clinical benefit. Moreover, proposing new lines of treatment after successive therapeutic failures may be a way of avoiding discussion of prognosis and advance care planning. It has been proposed that systems not providing overly aggressive care near the end of life would be the ones in which less than 10% of patients receive chemotherapy in the last 14 days of life. Presently the first consultation between patient and oncologist is ruled in France by the first "Plan Cancer" and the "Dispositif d'annonce" (announcement planning). Oncologists are supposed to explain the diagnosis of cancer and to present a treatment plan. In routine practice for metastatic non curable cancer patients, chemotherapy is presented as the leading therapy and its side effects are explained. The use of chemotherapy has been associated with the worsening of two major competitive life-threatening conditions for cancer patients: cachexia and thrombo-embolic events. Nevertheless the risk of worsening both those conditions is hardly explained in routine practice.
This study proposes to examine in a monocentric interventional prospective randomized trial, the impact of a particular way for the oncologist to present chemotherapy at the diagnosis stage on the easiness of timely chemotherapy interruption at the end of life. The main objective is to determine whether or not the explanation of the potential role of anticancer chemotherapy in worsening life-threatening conditions impacts the proportion of patients receiving chemotherapy in the last 30 days of life compared with usual presentation. Secondary objectives are to determine the impact of this communication strategy on overall survival and other indicators of aggressiveness of care and palliative care resources use.
Read more
The hypothesis is that the intervention will allow 15% of patients receiving anticancer therapy during the last 30 days of life, as compared to 30% in the control group.
The investigators expect that the intervention evaluated in this study will reduce the rate of patients receiving chemotherapy during the last 30 days of life hopefully improving the quality of end of life care. A secondary objective is overall survival and this study will therefore verify that the intervention arm is not associated with poorer overall survival. But more probably investigators expect patients in the intervention arm to have an improved overall survival mainly link to a decrease in harms due to chemotherapy given near the end of life and to better palliative care. In effect the hypothesis is that showing the life-threatening risks associated with chemotherapy and thus reducing for patients the importance of this treatment will leave room for improved palliative care as shown notably by earlier and more frequent referral to palliative care specialists. If this trial is positive, it will prove the capital role of patient-doctor communication in cancer care and that few differences in communication strategy could improve end of life care and maybe even survival. The impact on the oncology community would be major since the intervention could be easily transposed in all practices at no additional cost. It would also emphasize the importance of communication skills and human relationship in the very technical field of medical oncology.
- Conditions
- Stage IV Lung Cancer
- Being tested
- Truthful information on chemotherapy risks, Standard of information
- Keywords
- Lung cancer, chemotherapy outcome, ethics, information
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truthful information on chemotherapy risksBehavioural
One of two trained oncologist will meet the patient and inform him following an interview-guideline
Standard of informationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard of information | Active comparator | Information on chemotherapy as done in routine practice following national and international guidelines Receives: Behavioral: Standard of information |
| Truthful information on chemotherapy risks | Experimental | Information on the potential role of anticancer chemotherapy in worsening life-threatening conditions Receives: Behavioral: Truthful information on chemotherapy risks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients receiving chemotherapy in the last 30 days of life
Measured: from date of inclusion until death, assessed up to 1 year
Secondary outcomes (11)
Patient knowledge of the goals of care assessed by questionnaire
Measured: 1 month after information
Patient knowledge of the goals of care assessed by questionnaire
Measured: 6 months after information
Number of survivals
Measured: at 1 year
Number of appeals to palliative care
Use of palliative care resources
Measured: from date of inclusion until death, assessed up to 1 year
Number of onco-palliative meetings
Measured: from date of inclusion until death, assessed up to 1 year
Number of use of emergency room, intensive care unit and hospice service in the last month of life
Measured: from date of inclusion until death, assessed up to 1 year
Number of unscheduled hospitalizations
Measured: from date of inclusion until death, assessed up to 1 year
Number of chemotherapy cycles received
Measured: from date of inclusion until death, assessed up to 1 year
Number of days spent in acute care
Measured: from date of inclusion until death, assessed up to 1 year
Number of days spent in conventional oncology hospital
Measured: from date of inclusion until death, assessed up to 1 year
Place of death
Measured: at death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study start15 Jul 2016
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
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 Stage IV Lung CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Olivier HUILLARD, MD, PhD, Study chair, Assistance Publique - Hôpitaux de ParisFrancois GOLDWASSER, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606149
- Sponsor's protocol ID
- K141201
- Other IDs
- 2015-A01135-44
- Acronym
- HIPPOCRATE
- Status last verified
- Sep 2025
- First submitted
- 11 Nov 2015
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
PubMed 35802350
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Truthful Information Concerning Chemotherapy on Chemotherapy Prescription at the End of Life : a Randomized Controlled Study in Non-curable Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT02606149
- Acronym / sponsor ID
- HIPPOCRATE / K141201
- Conditions
- Stage IV Lung Cancer
- Keywords
- Lung cancer, chemotherapy outcome, ethics, information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 17 Nov 2015 (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.
Patients with metastatic cancer have a substantial symptom burden and may receive aggressive care at the end of life. There is evidence that the use of chemotherapy near the end of life is not related to its likelihood of providing benefit and the overuse of aggressive anticancer therapies near the end of life may result in more toxicity than clinical benefit. Moreover, proposing new lines of treatment after successive therapeutic failures may be a way of avoiding discussion of prognosis and advance care planning. It has been proposed that systems not providing overly aggressive care near the end of life would be the ones in which less than 10% of patients receive chemotherapy in the last 14 days of life. Presently the first consultation between patient and oncologist is ruled in France by the first "Plan Cancer" and the "Dispositif d'annonce" (announcement planning). Oncologists are supposed to explain the diagnosis of cancer and to present a treatment plan. In routine practice for metastatic non curable cancer patients, chemotherapy is presented as the leading therapy and its side effects are explained. The use of chemotherapy has been associated with the worsening of two major competitive life-threatening conditions for cancer patients: cachexia and thrombo-embolic events. Nevertheless the risk of worsening both those conditions is hardly explained in routine practice.
This study proposes to examine in a monocentric interventional prospective randomized trial, the impact of a particular way for the oncologist to present chemotherapy at the diagnosis stage on the easiness of timely chemotherapy interruption at the end of life. The main objective is to determine whether or not the explanation of the potential role of anticancer chemotherapy in worsening life-threatening conditions impacts the proportion of patients receiving chemotherapy in the last 30 days of life compared with usual presentation. Secondary objectives are to determine the impact of this communication strategy on overall survival and other indicators of aggressiveness of care and palliative care resources use.
The hypothesis is that the intervention will allow 15% of patients receiving anticancer therapy during the last 30 days of life, as compared to 30% in the control group.
The investigators expect that the intervention evaluated in this study will reduce the rate of patients receiving chemotherapy during the last 30 days of life hopefully improving the quality of end of life care. A secondary objective is overall survival and this study will therefore verify that the intervention arm is not associated with poorer overall survival. But more probably investigators expect patients in the intervention arm to have an improved overall survival mainly link to a decrease in harms due to chemotherapy given near the end of life and to better palliative care. In effect the hypothesis is that showing the life-threatening risks associated with chemotherapy and thus reducing for patients the importance of this treatment will leave room for improved palliative care as shown notably by earlier and more frequent referral to palliative care specialists. If this trial is positive, it will prove the capital role of patient-doctor communication in cancer care and that few differences in communication strategy could improve end of life care and maybe even survival. The impact on the oncology community would be major since the intervention could be easily transposed in all practices at no additional cost. It would also emphasize the importance of communication skills and human relationship in the very technical field of medical oncology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of information | Active comparator | Behavioral: Standard of informationInformation on chemotherapy as done in routine practice following national and international guidelines |
| Truthful information on chemotherapy risks | Experimental | Behavioral: Truthful information on chemotherapy risksInformation on the potential role of anticancer chemotherapy in worsening life-threatening conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- stage IV lung cancer, histologically proven
- > 18 years old
- diagnosed during the last 8 weeks
- systemic therapy indicated
Key exclusion criteria (4 listed)
- prior systemic therapy for metastatic disease
- comorbidity not compatible with the inclusion according to the investigator
- patient has not given its non-objection or not being able to give
- patient unaffiliated or not beneficiary of a social security scheme
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 |
|---|---|---|
| Truthful information on chemotherapy risksOne of two trained oncologist will meet the patient and inform him following an interview-guideline | Behavioural | Truthful information on chemotherapy risks |
| Standard of information | Behavioural | Standard of information |
Primary outcome
Number of patients receiving chemotherapy in the last 30 days of life
Time frame: from date of inclusion until death, assessed up to 1 year
11 secondary outcomes
Patient knowledge of the goals of care assessed by questionnaire
Time frame: 1 month after information
Patient knowledge of the goals of care assessed by questionnaire
Time frame: 6 months after information
Number of survivals
Time frame: at 1 year
Number of appeals to palliative care
Time frame: from date of inclusion until death, assessed up to 1 year
Number of onco-palliative meetings
Time frame: from date of inclusion until death, assessed up to 1 year
Number of use of emergency room, intensive care unit and hospice service in the last month of life
Time frame: from date of inclusion until death, assessed up to 1 year
Number of unscheduled hospitalizations
Time frame: from date of inclusion until death, assessed up to 1 year
Number of chemotherapy cycles received
Time frame: from date of inclusion until death, assessed up to 1 year
Number of days spent in acute care
Time frame: from date of inclusion until death, assessed up to 1 year
Number of days spent in conventional oncology hospital
Time frame: from date of inclusion until death, assessed up to 1 year
Place of death
Time frame: at death
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 20 Nov 2025.
- Derived from this study: PubMed 35802350Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
Related trials for Stage IV Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
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.
Olivier HUILLARD, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
Francois GOLDWASSER, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Truthful information on chemotherapy risks and Standard of information in people with Stage IV Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 inclusion and 4 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 20 Nov 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 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?
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?
Number of patients receiving chemotherapy in the last 30 days of life (time frame: from date of inclusion until death, assessed up to 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 NCT02606149, 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 20 Nov 2025.