An observational study in Lymphoma, Digestive System Diseases and Ovarian Diseases, sponsored by Institut Bergonié. Completed at 18 sites in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2022-02-04.
Sponsored by Institut Bergonié · Observational
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.
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's enrollment of 364 is above the median of 167 across 393 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Number of Participant Deaths
Number of participant deaths observed during the course of the study
Time frame: 6 months after inclusion
| Milestone | Eligible Patients |
|---|---|
| Started | 364 |
| Completed | 348 |
| Not completed | 16 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Protocol violation | 11 |
Number of participant deaths observed during the course of the study
| Participants | Eligible Patients |
|---|---|
| Number of Participant Deaths | 56 |
Collected over Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eligible Patients | 56/348 (16.1%) | — | — |
| Age, Continuous(years) | Eligible Patients |
|---|---|
| Median | 77.45 (70 to 99.4) |
| Sex: Female, Male(Participants) | Eligible Patients |
|---|---|
| Female | 157 |
| Male | 207 |
| Region of Enrollment(participants) | Eligible Patients |
|---|---|
| France | 364 |
Plan to share: No
Ran from Sep 2002 to primary completion in Sep 2007, 60 months.
Results were first posted in Jan 2022, 14 years 4 months after primary completion.
Of 140 non-industry observational studies under Lymphoma, half reached primary completion within 90 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 269. This study's 60 months is below that.
Counting every sponsor, half of 159 studies reached it within 82 months; a quarter within 39 and three quarters within 269.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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