LymphomaPHRC2003NCT00210249
Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment
An observational study of Lymphoma and Digestive System Diseases, run by Institut Bergonié at 18 sites in France.
Trial summary
Incidence of cancer in 75+ years old is 16,500 new cases per year, more than fifty percent of people with cancerThey are very few therapeutic trials dedicated. Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of breaking down quality of life. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Lymphoma, Digestive System Diseases, Ovarian Diseases
- How many people
- 364 participants
- Where
- 18 sitesFrance
- Study dates
- Sep 2002to Sep 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients greater than 70 year of age (no upper age limit) who were scheduled to receive first-line chemotherapy for various types of cancer (ie, colon, pancreas, stomach, ovary, bladder, prostate, lung cancer, non-Hodgkin's lymphoma [NHL], or cancer of unknown primary origin), excluding breast cancer, were eligible for inclusion. Patients with known CNS metastases were excluded.
Who may be able to join
- Age ≥ 70 years
- First line of chemotherapy
- Cancer previously mentioned
Who cannot join
None listed.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Centre de radiothérapie d'Agen
Agen, 47000
Centre Hospitalier Universitaire d'Agen
Agen, 47000
Clinique Esquirol Saint Hilaire
Agen, 47000
Centre Hospitalier Universitaire de Bayonne
Bayonne, 64000
Centre Hospitalier de la Côte Basque
Bayonne, 64100
Clinique Saint Etienne du Pays Basque
Bayonne, 64100
Clinique Tivoli
Bordeaux, 33000
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33076
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, 33076
Centre Hospitalier Universitaire de Dax
Dax, 40100
Hopital Sub-Urbain du Bouscat
Le Bouscat, 33110
Hôpital Robert Boulin
Libourne, 33500
Centre Hospitalier Universitaire de Mont de Marsan
Mont-de-Marsan, 40000
Centre Hospitalier Universitaire de Pau
Pau, 64000
Centre Hospitalier Universitaire de Perigueux
Périgueux, 24000
Clinique Francheville
Périgueux, 24000
Maison de Santé Protestante Bagatelle
Talence, 33400
Centre Hospitalier Universitaire de Villeneuve sur Lot
Villeneuve-sur-Lot, 47000
About this study
Official title: Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.
Incidence of cancer in 75+ years old is 16,500 new cases per year, more than fifty percent of people with cancerThey are very few therapeutic trials dedicated. Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of breaking down quality of life. Consequently, we decided to launch a protocol with both oncologists and geriatricians which principal aim is to find out if geriatric assessment data can help to better predict for chemotherapy toxicity, loss of autonomy and survival. We plan to accrue 360 patients diagnosed for cancer, including digestive, pulmonary, prostate, lymphoma, bladder, ovary cancer for whom first-line chemotherapy is planned. Patients are initially classified according to usual methods of medical oncology practice into three groups: patients who can receive standard treatment, reduced standard treatment or treatment adapted to the frail condition. Around Aquitaine, , we organised seven teams composed of one geriatrician and one nurse. Two kind of teams were activated: one which cover ten treatment sites in Bordeaux area and six sedentary teams which worked half a day a week in designated hospitals . Geriatric evaluation included test of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL;IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening. Patients have four geriatric evaluations : before treatment, day 1 cycle 2, day 1 cycle 4, day 1 cycle 7 and/or end of chemotherapy. Since September 2002, 177 patients have been included, 112 have finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3% stopped because they were in progression and changed their treatment, 11.6% met administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and 3.6% finished their treatment before. The following results have been obtained: before treatment, 73% of these patients were at risk of undernutrition (MNA< 23.5), about 1/3 had one or more inability or a risk of falls (38% IADL<6, 29% get up and go>20seconds, 27% ADL>1, 34% PS<1), 28% of them had altered cognitive functions (MMS<24), 29% were depressive (GDS-15>6), 25% thought they had poor quality of life (QLQ-C30<4). Protocol will be closed in September 2005.
- Conditions
- Lymphoma, Digestive System Diseases, Ovarian Diseases, Pulmonary Disease, Prostatic Disease, Bladder Disease
- Keywords
- Cancer, elderly, geriatric evaluation, safety, chemotherapy
- Medical subject headings
- Lymphoma, Digestive System Diseases, Ovarian Diseases, Lung Diseases, Prostatic Diseases, Urinary Bladder Diseases, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant Deaths
Number of participant deaths observed during the course of the study
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionSep 2007
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo, Aventis Pharmaceuticals, Amgen, Chugai Pharmaceutical, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Pierre SOUBEYRAN, MD, PhD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210249
- Sponsor's protocol ID
- IB2002-26
- Other IDs
- PHRC OncoG
- Acronym
- PHRC2003
- Status last verified
- Jan 2022
- First submitted
- 13 Sep 2005
- Last updated
- 4 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
Soubeyran P, Fonck M, Blanc-Bisson C, Blanc JF, Ceccaldi J, Mertens C, Imbert Y, Cany L, Vogt L, Dauba J, Andriamampionona F, Houede N, Floquet A, Chomy F, Brouste V, Ravaud A, Bellera C, Rainfray M. Predictors of early death risk in older patients treated with first-line chemotherapy for cancer. J Clin Oncol. 2012 May 20;30(15):1829-34. doi: 10.1200/JCO.2011.35.7442. Epub 2012 Apr 16.
PubMed 22508806de Salins V, Martinez-Tapia C, Gay P, Morel A, Bringuier M, Boudou-Rouquette P, Corsin L, Aregui A, Canovas J, Rautou PE, Soubeyran P, Bellera C, Canoui-Poitrine F, Paillaud E, Poisson J. The Fibrosis-4 score is associated with overall mortality and severe haematological toxicity in older patients with cancer: Analysis of two prospective cohort studies. Int J Cancer. 2025 Dec 15;157(12):2506-2520. doi: 10.1002/ijc.70071. Epub 2025 Aug 6.
PubMed 40767026Hoppe S, Rainfray M, Fonck M, Hoppenreys L, Blanc JF, Ceccaldi J, Mertens C, Blanc-Bisson C, Imbert Y, Cany L, Vogt L, Dauba J, Houede N, Bellera CA, Floquet A, Fabry MN, Ravaud A, Chakiba C, Mathoulin-Pelissier S, Soubeyran P. Functional decline in older patients with cancer receiving first-line chemotherapy. J Clin Oncol. 2013 Nov 1;31(31):3877-82. doi: 10.1200/JCO.2012.47.7430. Epub 2013 Sep 23.
PubMed 24062399
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.
- ClinicalTrials.gov ID
- NCT00210249
- Acronym / sponsor ID
- PHRC2003 / IB2002-26
- Conditions
- Lymphoma, Digestive System Diseases, Ovarian Diseases, Pulmonary Disease, Prostatic Disease, Bladder Disease
- Keywords
- Cancer, elderly, geriatric evaluation, safety, chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Sanofi-Synthelabo, Aventis Pharmaceuticals, Amgen, Chugai Pharmaceutical, Bristol-Myers Squibb
- Study start
- Sep 2002 (actual)
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 12 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Incidence of cancer in 75+ years old is 16,500 new cases per year, more than fifty percent of people with cancerThey are very few therapeutic trials dedicated. Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of breaking down quality of life. Consequently, we decided to launch a protocol with both oncologists and geriatricians which principal aim is to find out if geriatric assessment data can help to better predict for chemotherapy toxicity, loss of autonomy and survival. We plan to accrue 360 patients diagnosed for cancer, including digestive, pulmonary, prostate, lymphoma, bladder, ovary cancer for whom first-line chemotherapy is planned. Patients are initially classified according to usual methods of medical oncology practice into three groups: patients who can receive standard treatment, reduced standard treatment or treatment adapted to the frail condition. Around Aquitaine, , we organised seven teams composed of one geriatrician and one nurse. Two kind of teams were activated: one which cover ten treatment sites in Bordeaux area and six sedentary teams which worked half a day a week in designated hospitals . Geriatric evaluation included test of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL;IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening. Patients have four geriatric evaluations : before treatment, day 1 cycle 2, day 1 cycle 4, day 1 cycle 7 and/or end of chemotherapy. Since September 2002, 177 patients have been included, 112 have finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3% stopped because they were in progression and changed their treatment, 11.6% met administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and 3.6% finished their treatment before. The following results have been obtained: before treatment, 73% of these patients were at risk of undernutrition (MNA< 23.5), about 1/3 had one or more inability or a risk of falls (38% IADL<6, 29% get up and go>20seconds, 27% ADL>1, 34% PS<1), 28% of them had altered cognitive functions (MMS<24), 29% were depressive (GDS-15>6), 25% thought they had poor quality of life (QLQ-C30<4). Protocol will be closed in September 2005.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients greater than 70 year of age (no upper age limit) who were scheduled to receive first-line chemotherapy for various types of cancer (ie, colon, pancreas, stomach, ovary, bladder, prostate, lung cancer, non-Hodgkin's lymphoma [NHL], or cancer of unknown primary origin), excluding breast cancer, were eligible for inclusion. Patients with known CNS metastases were excluded.
Key inclusion criteria (3 listed)
- Age ≥ 70 years
- First line of chemotherapy
- Cancer previously mentioned
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participant Deaths
Time frame: 6 months after inclusion
Number of participant deaths observed during the course of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22508806Soubeyran P, Fonck M, Blanc-Bisson C, Blanc JF, Ceccaldi J, Mertens C, Imbert Y, Cany L, Vogt L, Dauba J, Andriamampionona F, Houede N, Floquet A, Chomy F, Brouste V, Ravaud A, Bellera C, Rainfray M. Predictors of early death risk in older patients treated with first-line chemotherapy for cancer. J Clin Oncol. 2012 May 20;30(15):1829-34. doi: 10.1200/JCO.2011.35.7442. Epub 2012 Apr 16.
- Derived from this study: PubMed 40767026de Salins V, Martinez-Tapia C, Gay P, Morel A, Bringuier M, Boudou-Rouquette P, Corsin L, Aregui A, Canovas J, Rautou PE, Soubeyran P, Bellera C, Canoui-Poitrine F, Paillaud E, Poisson J. The Fibrosis-4 score is associated with overall mortality and severe haematological toxicity in older patients with cancer: Analysis of two prospective cohort studies. Int J Cancer. 2025 Dec 15;157(12):2506-2520. doi: 10.1002/ijc.70071. Epub 2025 Aug 6.
- Derived from this study: PubMed 24062399Hoppe S, Rainfray M, Fonck M, Hoppenreys L, Blanc JF, Ceccaldi J, Mertens C, Blanc-Bisson C, Imbert Y, Cany L, Vogt L, Dauba J, Houede N, Bellera CA, Floquet A, Fabry MN, Ravaud A, Chakiba C, Mathoulin-Pelissier S, Soubeyran P. Functional decline in older patients with cancer receiving first-line chemotherapy. J Clin Oncol. 2013 Nov 1;31(31):3877-82. doi: 10.1200/JCO.2012.47.7430. Epub 2013 Sep 23.
- Individual participant dataSharing planned: No
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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.
Pierre SOUBEYRAN, MD, PhD principal investigator
Institut Bergonié
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Digestive System Diseases, run by Institut Bergonié at 18 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 3 inclusion and 0 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Yes. Results are posted in the registry (first posted 12 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participant Deaths (time frame: 6 months after inclusion). 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 NCT00210249, which also lists 3 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 4 Feb 2022.