Metastatic Colorectal AdenocarcinomaPhase 2Prodige20NCT01900717
Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)
A Phase 2 study testing LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified and LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks in people with Metastatic Colorectal Adenocarcinoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years and older. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Metastatic Colorectal Adenocarcinoma
- What is being tested?
- LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified and LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Mar 2016
- Phase
- Phase 2
- 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
Who may be able to join
- Patients aged 75 years or older
- ECOG ≤2
- histologically proven unresectable metastatic colorectal adenocarcinoma
- Measurable lesion according to RECIST criteria
- Absence of prior chemotherapy for metastatic disease. Adjuvant chemotherapy following resection of the primary tumor is authorized if completed more than 6 months previously
- Patients treated with anticoagulants (coumadin, warfarin) can be included if close surveillance of the INR can be ensured. A change to low-molecular-weight heparin is preferable as long as the indications are respected
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- Completed geriatric self-questionnaire
- Completed "Team" geriatric questionnaire (including Spitzer QoL Index)
- Written informed consent
Who cannot join
- Estimated life expectancy < 3 months
- Non-resolved intestinal occlusion or sub-occlusion
- Cerebral metastasis
- Other evolutive malignant tumor (non-stabilized cancer for less than 2 years)
- Evolutive gastroduodenal ulcer, wound or bone fracture
- Active heart disease: uncontrolled hypertension, myocardial infarction In the previous 6 months, angina, non-compensated congestive heart failure
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- Major surgery, except for biopsy, or irradiation in the 4 weeks preceding the start of treatment
- Polynuclear neutrophils <1500/mm3, platelets <100 000/mm3 or 24-h proteinuria > 1g
- History of arterial thromboembolic event (cerebrovascular accident, transient ischemic attack, subarachnoid hemorrhage) in the 12 months preceding the first dose of bevacizumab
- History of distal or visceral ischemia ≥ grade 2 in the 12 months preceding the first dose of bevacizumab
- History of life-threatening pulmonary embolism in the 6 months preceding the first dose of bevacizumab
- Impossibility to ensure regular follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma
To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years and older.
This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.
- Conditions
- Metastatic Colorectal Adenocarcinoma
- Being tested
- LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified, LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modifiedDrug
LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeksDrug
| Study group | Role | What they receive |
|---|---|---|
| chimiotherapy alone | Active comparator | * LV5FU2 simplified,
* 5-fluorouracil/leucovorin with oxaliplatin 4 (FOLFOX) simplified,
* fluorouracil, leucovorin, and irinotecan(FOLFIRI) modified. Receives: Drug: LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified |
| chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks | Experimental | * LV5FU2 simplified,
* FOLFOX 4 simplified,
* FOLFIRI modified.
* Bevacizumab 5 mg/kg/ 2 weeks Receives: Drug: LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial examination
thoraco-abdomino-pelvic tomodensitometry or thoracic tomodensitometry and abdomino-pelvic MRI with identification and measurement of the target tumors according to RECIST (Response Evaluation Criteria in Solid Tumors
)criteria.
Measured: 21 days before the first course of treatment
Secondary outcomes (1)
Initial examination
Medical history, clinical examination (HR, arterial blood pressure
, temperature, weight, height, Eastern Cooperative Oncology Group performance status),
- measurement of body surface area, ECG
- completion of questionnaire by the patient (annexe 1),
- completion of geriatric questionnaire "team" (annexe 2)
- biological examination including:
- full blood count-platelets
- blood electrolyte panel, creatinemia
- Albumin
- ASAT, ALAT, PAL, GGT, total and conjugated bilirubin
- CEA, CA 19.9, LDH markers
- balanced INR for patients on AVK
- Urinary dip with 24-hour proteinuria if > 1+
- Measurement of creatinine clearance using the Cockcroft formula (in men: (140-age) x weight (kg)/0.814 x creatinemia (μmol), in women: (140-age) x weight (kg)/0.85 x creatinemia (μmol)),
- In the absence of a cardiological examination in the year before or in the case of a history of severe cardiovascular disease: consultation in cardiology.
Measured: 14 days before inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJul 2011
- Primary completionMay 2015
- Study completionMar 2016
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 Metastatic Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900717
- Sponsor's protocol ID
- Bedenne PHRC K 2010.
- Other IDs
- 2010-022080-34
- Acronym
- Prodige20
- Status last verified
- Dec 2018
- First submitted
- 12 Jul 2013
- Last updated
- 27 Dec 2018
- Results posted
- No
Publications
Dohan A, Gallix B, Guiu B, Le Malicot K, Reinhold C, Soyer P, Bennouna J, Ghiringhelli F, Barbier E, Boige V, Taieb J, Bouche O, Francois E, Phelip JM, Borel C, Faroux R, Seitz JF, Jacquot S, Ben Abdelghani M, Khemissa-Akouz F, Genet D, Jouve JL, Rinaldi Y, Desseigne F, Texereau P, Suc E, Lepage C, Aparicio T, Hoeffel C; PRODIGE 9 Investigators and PRODIGE 20 Investigators. Early evaluation using a radiomic signature of unresectable hepatic metastases to predict outcome in patients with colorectal cancer treated with FOLFIRI and bevacizumab. Gut. 2020 Mar;69(3):531-539. doi: 10.1136/gutjnl-2018-316407. Epub 2019 May 17.
PubMed 31101691
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01900717
- Acronym / sponsor ID
- Prodige20 / Bedenne PHRC K 2010.
- Conditions
- Metastatic Colorectal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Jul 2013 (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.
To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years and older.
This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chimiotherapy alone | Active comparator | Drug: LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified* LV5FU2 simplified, * 5-fluorouracil/leucovorin with oxaliplatin 4 (FOLFOX) simplified, * fluorouracil, leucovorin, and irinotecan(FOLFIRI) modified. |
| chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks | Experimental | Drug: LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks* LV5FU2 simplified, * FOLFOX 4 simplified, * FOLFIRI modified. * Bevacizumab 5 mg/kg/ 2 weeks |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Patients aged 75 years or older
- ECOG ≤2
- histologically proven unresectable metastatic colorectal adenocarcinoma
- Measurable lesion according to RECIST criteria
- Absence of prior chemotherapy for metastatic disease. Adjuvant chemotherapy following resection of the primary tumor is authorized if completed more than 6 months previously
Key exclusion criteria (12 listed)
- Estimated life expectancy < 3 months
- Non-resolved intestinal occlusion or sub-occlusion
- Cerebral metastasis
- Other evolutive malignant tumor (non-stabilized cancer for less than 2 years)
- Evolutive gastroduodenal ulcer, wound or bone fracture
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 |
|---|---|---|
| LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified | Drug | chimiotherapy alone |
| LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks | Drug | chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks |
Primary outcome
Initial examination
Time frame: 21 days before the first course of treatment
thoraco-abdomino-pelvic tomodensitometry or thoracic tomodensitometry and abdomino-pelvic MRI with identification and measurement of the target tumors according to RECIST (Response Evaluation Criteria in Solid Tumors )criteria.
1 secondary outcome
Initial examination
Time frame: 14 days before inclusion
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 27 Dec 2018.
- Derived from this study: PubMed 31101691Dohan A, Gallix B, Guiu B, Le Malicot K, Reinhold C, Soyer P, Bennouna J, Ghiringhelli F, Barbier E, Boige V, Taieb J, Bouche O, Francois E, Phelip JM, Borel C, Faroux R, Seitz JF, Jacquot S, Ben Abdelghani M, Khemissa-Akouz F, Genet D, Jouve JL, Rinaldi Y, Desseigne F, Texereau P, Suc E, Lepage C, Aparicio T, Hoeffel C; PRODIGE 9 Investigators and PRODIGE 20 Investigators. Early evaluation using a radiomic signature of unresectable hepatic metastases to predict outcome in patients with colorectal cancer treated with FOLFIRI and bevacizumab. Gut. 2020 Mar;69(3):531-539. doi: 10.1136/gutjnl-2018-316407. Epub 2019 May 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified and LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks in people with Metastatic Colorectal Adenocarcinoma, run by Centre Hospitalier Universitaire Dijon 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 9 inclusion and 12 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 27 Dec 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Initial examination (time frame: 21 days before the first course of treatment). 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 NCT01900717, 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 27 Dec 2018.