Trial record 2 of 2 for:
oncog
Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment (PHRC2003)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00210249 |
|
Recruitment Status :
Completed
First Posted : September 21, 2005
Results First Posted : January 12, 2022
Last Update Posted : February 4, 2022
|
Sponsor:
Institut Bergonié
Collaborators:
Sanofi-Synthelabo
Aventis Pharmaceuticals
Amgen
Chugai Pharmaceutical
Bristol-Myers Squibb
Information provided by (Responsible Party):
Institut Bergonié
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief 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. 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.
| Condition or disease |
|---|
| Lymphoma Digestive System Diseases Ovarian Diseases Pulmonary Disease Prostatic Disease Bladder Disease |
| Study Type : | Observational |
| Actual Enrollment : | 364 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country. |
| Actual Study Start Date : | September 2002 |
| Actual Primary Completion Date : | September 2007 |
| Actual Study Completion Date : | September 2008 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Number of Participant Deaths [ Time Frame: 6 months after inclusion ]Number of participant deaths observed during the course of the study
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Criteria
Inclusion criteria:
- Age ≥ 70 years
- First line of chemotherapy
- Cancer previously mentioned
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210249
Locations
Show 18 study locations
Sponsors and Collaborators
Institut Bergonié
Sanofi-Synthelabo
Aventis Pharmaceuticals
Amgen
Chugai Pharmaceutical
Bristol-Myers Squibb
Investigators
| Principal Investigator: | Pierre SOUBEYRAN, MD, PhD | Institut Bergonié |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Institut Bergonié |
| ClinicalTrials.gov Identifier: | NCT00210249 |
| Other Study ID Numbers: |
IB2002-26 PHRC OncoG ( Other Identifier: Institut Bergonié ) |
| First Posted: | September 21, 2005 Key Record Dates |
| Results First Posted: | January 12, 2022 |
| Last Update Posted: | February 4, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Institut Bergonié:
|
Cancer elderly geriatric evaluation safety chemotherapy |
Additional relevant MeSH terms:
|
Digestive System Diseases Gastrointestinal Diseases Urinary Bladder Diseases Prostatic Diseases Ovarian Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Male Urogenital Diseases Genital Diseases, Male Genital Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases |