Solid Tumor Regardless of Localization and StagePhase 4OLDNCT00664911
Combination Chemotherapy in Treating Older Patients With Solid Tumour,
A Phase 4 study testing chemotherapy in people with Solid Tumor Regardless of Localization and Stage, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 29 sites in France.
Trial summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Solid Tumor Regardless of Localization and Stage
- What is being tested?
- chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 29 sitesFrance
- Study dates
- Mar 2008to Oct 2013
- Phase
- Phase 4
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumour regardless of localization or stage
PATIENT CHARACTERISTICS:
- > or = 75 years
- patient planned to receive > or = 2/3 of standard dose of the first cycle
PRIOR CONCURRENT THERAPY:
Chemonaive patient.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
France29 sites
Centre Radiotherapie Oncologie Moyenne Garonne
Agen, 47000
Centre Hospitalier de Castelluccio
Ajaccio, 20176
Centre Hospitalier d'Ardeche Meridionale
Aubenas, 07205
Centre Hospitalier d'Auxerre
Auxerre, 89011
Institut Sainte Catherine
Avignon, 84000
Hopital Duffaut
Avignon, 84902
Centre Hospitalier de Beauvais
Beauvais, 60021
Clinique des Cedres
Cornebarrieu, 31700
Centre Medico-Chirurgical et Obstetrique d'Evry
Évry, 91000
Hopital Clarac
Fort de France Cedex, 97261
Centre Hospitalier Intercommunal des Alpes du Sud
Gap, 05007
Centre Hospitalier de Lagny
Lagny-sur-Marne, 77405
Centre Hospitalier St. Joseph St. Luc
Lyon, 69007
Hopital Prive Jean Mermoz
Lyon, 69008
Centre Hospitalier Chanaux
Mâcon, 71018
Centre Hospitalier de Montelimar
Montélimar, 26200
Hopital Bichat - Claude Bernard
Paris, 75018
Hopital de la Croix St. Simon
Paris, 75020
Hopital Saint Antoine
Paris, 75571
Hopital Tenon
Paris, 75970
Hopital Rene Dubos
Pontoise, 95300
Institut Jean Godinot
Reims, 51056
Centre Hospitalier Prive Saint-Gregoire
Saint-Grégoire, 35768
Centre Hospitalier de Saint-Quentin
Saint-Quentin, 02321
Centre Hospitalier de Semur en Auxois
Semur-en-Auxois, 21140
C.H. Senlis
Senlis, 60309
Hopital Foch
Suresnes, 92151
Centre hospitalier de Tonnerre
Tonnerre, 89700
Centre Hospitalier Villeneuve Saint Georges
Villeneuve-Saint-Georges, 94195
About this study
Official title: Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Solid Tumour
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating older patients with solid tumour.
Read the detailed description
OBJECTIVES:
Primary
- To determine a prognostic scale of the feasibility of chemotherapy (at least two-thirds of the dose intensity usually administered) in patients aged 75 years or older with solid tumour.
Secondary
- To evaluate the efficacy, in terms of clinical and/or biological response, of treatments administered.
- To evaluate the incidence of severe (grade 3-4) toxicity.
OUTLINE: This is a multicenter study. Patients receive one of the following regimens according to cancer diagnosis and principal investigator preference. All regimens last 3 months.
- Being tested
- chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Other | chemotherapy regimen Receives: Other: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
chemotherapy feasibility
ability to deliver at least 3 months of the planned regimen therapy.
Measured: from inclusion to 3 months
Number of patients receiving therapeutic dose-intensive therapy (doses must be at least equivalent to two-thirds the dose that is usually administered according to AMM recommendations)
dose reduction < 33%
Measured: 3 months
Secondary outcomes (1)
Grade 3-4 toxicities according to NCI-CTCAE version 3
Measured: from inclusion to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor Regardless of Localization and StageStudies 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
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Carola, MD, Study chair, C.H. Senlis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664911
- Sponsor's protocol ID
- CDR0000593133
- Other IDs
- GERCOR-OLD, EudraCT-2007004103-36
- Acronym
- OLD
- Status last verified
- Oct 2013
- First submitted
- 22 Apr 2008
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Solid Tumour
- ClinicalTrials.gov ID
- NCT00664911
- Acronym / sponsor ID
- OLD / CDR0000593133
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Apr 2008 (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.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating older patients with solid tumour.
Detailed description
OBJECTIVES:
Primary
- To determine a prognostic scale of the feasibility of chemotherapy (at least two-thirds of the dose intensity usually administered) in patients aged 75 years or older with solid tumour.
Secondary
- To evaluate the efficacy, in terms of clinical and/or biological response, of treatments administered.
- To evaluate the incidence of severe (grade 3-4) toxicity.
OUTLINE: This is a multicenter study. Patients receive one of the following regimens according to cancer diagnosis and principal investigator preference. All regimens last 3 months.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Other | Other: chemotherapychemotherapy regimen |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| chemotherapy | Other | Chemotherapy |
Primary outcome
chemotherapy feasibility
Time frame: from inclusion to 3 months
ability to deliver at least 3 months of the planned regimen therapy.
Number of patients receiving therapeutic dose-intensive therapy (doses must be at least equivalent to two-thirds the dose that is usually administered according to AMM recommendations)
Time frame: 3 months
dose reduction < 33%
1 secondary outcome
Grade 3-4 toxicities according to NCI-CTCAE version 3
Time frame: from inclusion to 3 months
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 16 Oct 2013.
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.
Elisabeth Carola, MD study chair
C.H. Senlis
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing chemotherapy in people with Solid Tumor Regardless of Localization and Stage, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 29 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?
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 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
chemotherapy feasibility (time frame: from inclusion to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2013; AzTrials last refreshed its copy on 3 Nov 2026.