Colorectal NeoplasmsPhase 2HIGH-LIGHTNCT02842580
De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer
A Phase 2 study testing 5 FLUOROURACYL, acide folinique and irinotecan in people with Colorectal Neoplasms, run by Federation Francophone de Cancerologie Digestive at 11 sites in France.
Trial summary
The intensity of tumour response appears to be correlated with the feasibility and the duration of a therapeutic pause or of a reduced maintenance therapy maintained until progression in patients initially controlled by so-called "induction" chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- 5 FLUOROURACYL, acide folinique and irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 11 sitesFrance
- Study dates
- Sep 2016to Oct 2020
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic colorectal cancer, histologically proven (on primary tumour and/or metastases)
- Unresectable and non-pretreated metastases
- BRAF wild-type
- Patient considered able to receive 3 lines of chemotherapy
- At least one measurable target lesion > 1 cm according to RECIST 1.1 (Appendix 4)
- Tumour assessment according to RECIST, performed 4 weeks or less prior to randomization
Show all 15Show fewer
- Age ≥ 18 years
- WHO performance status ≤ 2 (Appendix 5)
- No major surgery within 4 weeks prior to randomisation. Wound healing must be complete
- Life expectancy greater than 3 months
- Laboratory tests: Neutrophils ≥ 1500/mm3, platelets ≥ 100,000/mm3, haemoglobin > 9 g/dL
- Creatinine clearance > 30 mL /min (capecitabine dose modification if the creatinine clearance < 30-50 mL/min), serum creatinine < 1.25 x ULN
- Liver function tests: bilirubin < 1.25 x ULN, AST/ALT < 5 x ULN
- Women of childbearing age and men (who have sexual relations with women of childbearing age) must agree to use effective contraception without interruption throughout the duration of treatment and for 6 months after the last administration
- Signed informed consent
Who cannot join
- Patient with a potentially resectable colorectal cancer; i.e. for whom the goal of chemotherapy would be to make all metastases resectable
- Patients with symptomatic metastases
- Patient with aggressive disease and a large tumour volume
- Active gastroduodenal ulcer, wound or bone fracture
- At least one of the following laboratory values: Neutrophils <1500/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dL, total bilirubin > 1.5 N, alkaline phosphatase > 2.5 N (or > 5 N in case of hepatic involvement), serum creatinine > 1.5 N, 24 hr proteinuria > 1 g
- Chronic inflammatory bowel disease, extensive resection of the small bowel
Show all 18Show fewer
- Clinically significant coronary artery disease or a history of myocardial infraction within the last 6 months. Uncontrolled hypertension while receiving chronic medication
- Abdominal or major extra-abdominal surgical procedure (except diagnostic biopsy) or radiation within 4 weeks before starting treatment
- Previous treatment with an anti-angiogenic or irinotecan
- Known or suspected central nervous system metastasis CNS metastases, or suspected CNS metastases
- Other previous malignancies within 5 years, except for basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix - Peritoneal macro-nodular carcinomatosis
- History of haemoptysis ≥ grade 2 (defined as ≥ 2.5 mL of bright red blood per episode) in the month prior to inclusion
- Known hypersensitivity to any component of bevacizumab or to one of the study treatments
- Active infection requiring intravenous antibiotics at start of treatment
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to treatment start
- Pregnant or breastfeeding women
- Concomitant participation in another clinical study involving a drug during the treatment phase and 30 days before starting the study treatment
- Patient unable to undergo medical treatment for geographical, social, psychological or legal reasons.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Hopital Pierre Oudot - Service de Gastroenterologie
Bourgoin, 38300
Ch de Cholet - Service Maladies de L4Appareil Digestif Du Dr Kaasis
Cholet, 49325
Chd Vendee - Service D'Hge
La Roche-sur-Yon, 85925
Ch Annecy Genevois - Service Hge
Pringy, 74374
CH - Annecy Genevois
Pringy
Chu Robert Debre - Medecine Ambulatoire-Cancerologie
Reims, 51092
CHU Robert DEBRE
Reims
Chu Charles Nicolle - Service D'Hge
Rouen, 76031
Hopital Prive Saint Gregoire - Service de Radiotherapie
Saint-Grégoire, 35768
Chu de Saint Etienne-Hopital Nord - Service Hge
Saint-Priest-en-Jarez, 42270
Centre Hospitalier de St Malo - Service Hepato-Gastro-Enterologie
St-Malo, 35403
About this study
Official title: Randomized Phase II Study Assessing the Efficacy and Safety of 2 Therapeutic Strategies Combining Bevacizumab With Chemotherapy: De-escalation Versus Escalation in Patients With Non-pretreated Unresectable Metastatic Colorectal Cancer
The intensity of tumour response appears to be correlated with the feasibility and the duration of a therapeutic pause or of a reduced maintenance therapy maintained until progression in patients initially controlled by so-called "induction" chemotherapy. Bevacizumab combined with cytotoxic chemotherapy (5-FU, irinotecan and/or oxaliplatin) has shown that it is possible to improve the tumour response rate and patient prognosis in 1st and 2nd lines. With a very favourable safety profile , it is an excellent candidate as induction treatment and also as maintenance treatment. Prospective data from recent trials have actually demonstrated improvement in PFS and/or overall survival with bevacizumab maintenance alone or in combination with 5FU (or capecitabine) after induction chemotherapy (FOLFIRI or FOLFOX + bevacizumab).
At the same time, the maintenance of anti-angiogenic pressure after progression in 1st line metastatic has demonstrated its benefit in terms of PFS and overall survival. Bevacizumab maintenance in 2nd line metastatic, despite progression, thus appears to be a valid strategy.
Read the detailed description
Thus, the objective of this work is to combine continuous blocking of angiogenesis by bevacizumab given on the first 3 metastatic lines in a randomised phase II trial evaluating a "descending" strategy of immediate optimisation by 4 cycles of FOLFOXIRI-bevacizumab and 4 cycles of FOLFIRI-bevacizumab, followed by maintenance treatment with 5FU-bevacizumab until progression (re-introduction of induction in case of progression) and evaluate an "ascending" strategy with 5FU-bevacizumab immediately followed, at progression, by the introduction of irinotecan, then oxaliplatin, with maintenance of blocking of angiogenesis by bevacizumab.
- Conditions
- Colorectal Neoplasms
- Being tested
- 5 FLUOROURACYL, acide folinique, irinotecan, Oxaliplatin, capécitabine
- Keywords
- colorectal, cancer, metastasis
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 FLUOROURACYLDrug
Also called FLUOROURACILE EBEWE
Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion.
The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2).
The cycles will last 14 days. For this 1st line chemotherapy, the investigator has the choice of using capecitabine instead of LV5FU2; in this case the cycle lasts 21 days.
acide foliniqueDrug
Also called ELVORINE
200 mg/m² if Elvorine
irinotecanDrug
Also called CAMPTO
Irinotecan is administered IV at a dose of 180 mg/m² over 90 minutes. Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with irinotecan.
The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2).
The cycles will last 14 days.
OxaliplatinDrug
Also called ELOXATINE 5 mg/ml
Oxaliplatin is administered IV at a dose of 85 mg/m² over 120 minutes. Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with oxaliplatin.
The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2).
The cycles will last 14 days.
capécitabineDrug
Also called XELODA
For this 1st line chemotherapy, the investigator has the choice of using capecitabine instead of LV5FU2; in this case the cycle lasts 21 days.
bevacizumabDrug
Also called AVASTIN
Bevacizumab is administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Standard arm (escalation strategy - arm A) | Active comparator | LV5FU2 (5 FLUOROURACYL)+avastin. After progression: FOLFIRI + avastin. after the 2nd progression:FOLFOX4 (eloxatine)+ avastin. Receives: Drug: 5 FLUOROURACYL; Drug: acide folinique; Drug: irinotecan; Drug: Oxaliplatin; Drug: capécitabine; Drug: bevacizumab |
| Experimental arm (de-escalation strategy -arm B) | Experimental | (4 cycles of FOLFOXIRI (campto) + avastin and 4 cycles of FOLFIRI + avastin) is followed by maintenance with capecitabine Receives: Drug: 5 FLUOROURACYL; Drug: acide folinique; Drug: irinotecan; Drug: Oxaliplatin; Drug: capécitabine; Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Objective Was the Percentage of Patients Without Failure of the Strategy 16 Months After the Randomization.
The failure of the strategy is defined by the following events:
- Progression (under certain condition) using RECIST version 1.1 and defined as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a nontarget lesion, or the appearance of new lesions
- Death (all causes)
- Toxicity leading to definitive stop of chemotherapy (oxaliplatine and/or irinotecan).
Measured: 16 months after randomization
Secondary outcomes (3)
Best Response Rate (Using RECIST Version 1.1)
Best response derived from all the CT scans performed during treatment and based on RECIST 1.1 definition of response.
Measured: At 16 months
Overall Survival (OS)
Overall survival was defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news was taken into account
Measured: Up to 3 years after the treatment start
Progression Free Survival (PFS)
The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a nontarget lesion, or the appearance of new lesions
Measured: up to 24 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2020
- Study completionOct 2020
Why it stopped: Inclusion rythm too slow.
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.
- Other trials for Colorectal NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Marc PHELIP, MD-PhD, Principal investigator, CHU St Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842580
- Sponsor's protocol ID
- PRODIGE 45
- Acronym
- HIGH-LIGHT
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2016
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study Assessing the Efficacy and Safety of 2 Therapeutic Strategies Combining Bevacizumab With Chemotherapy: De-escalation Versus Escalation in Patients With Non-pretreated Unresectable Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02842580
- Acronym / sponsor ID
- HIGH-LIGHT / PRODIGE 45
- Conditions
- Colorectal Neoplasms
- Keywords
- colorectal, cancer, metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion rythm too slow.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intensity of tumour response appears to be correlated with the feasibility and the duration of a therapeutic pause or of a reduced maintenance therapy maintained until progression in patients initially controlled by so-called "induction" chemotherapy. Bevacizumab combined with cytotoxic chemotherapy (5-FU, irinotecan and/or oxaliplatin) has shown that it is possible to improve the tumour response rate and patient prognosis in 1st and 2nd lines. With a very favourable safety profile , it is an excellent candidate as induction treatment and also as maintenance treatment. Prospective data from recent trials have actually demonstrated improvement in PFS and/or overall survival with bevacizumab maintenance alone or in combination with 5FU (or capecitabine) after induction chemotherapy (FOLFIRI or FOLFOX + bevacizumab).
At the same time, the maintenance of anti-angiogenic pressure after progression in 1st line metastatic has demonstrated its benefit in terms of PFS and overall survival. Bevacizumab maintenance in 2nd line metastatic, despite progression, thus appears to be a valid strategy.
Detailed description
Thus, the objective of this work is to combine continuous blocking of angiogenesis by bevacizumab given on the first 3 metastatic lines in a randomised phase II trial evaluating a "descending" strategy of immediate optimisation by 4 cycles of FOLFOXIRI-bevacizumab and 4 cycles of FOLFIRI-bevacizumab, followed by maintenance treatment with 5FU-bevacizumab until progression (re-introduction of induction in case of progression) and evaluate an "ascending" strategy with 5FU-bevacizumab immediately followed, at progression, by the introduction of irinotecan, then oxaliplatin, with maintenance of blocking of angiogenesis by bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm (escalation strategy - arm A) | Active comparator | Drug: 5 FLUOROURACYL, Drug: acide folinique, Drug: irinotecan, Drug: Oxaliplatin, Drug: capécitabine, Drug: bevacizumabLV5FU2 (5 FLUOROURACYL)+avastin. After progression: FOLFIRI + avastin. after the 2nd progression:FOLFOX4 (eloxatine)+ avastin. |
| Experimental arm (de-escalation strategy -arm B) | Experimental | Drug: 5 FLUOROURACYL, Drug: acide folinique, Drug: irinotecan, Drug: Oxaliplatin, Drug: capécitabine, Drug: bevacizumab(4 cycles of FOLFOXIRI (campto) + avastin and 4 cycles of FOLFIRI + avastin) is followed by maintenance with capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Metastatic colorectal cancer, histologically proven (on primary tumour and/or metastases)
- Unresectable and non-pretreated metastases
- BRAF wild-type
- Patient considered able to receive 3 lines of chemotherapy
- At least one measurable target lesion > 1 cm according to RECIST 1.1 (Appendix 4)
Key exclusion criteria (18 listed)
- Patient with a potentially resectable colorectal cancer; i.e. for whom the goal of chemotherapy would be to make all metastases resectable
- Patients with symptomatic metastases
- Patient with aggressive disease and a large tumour volume
- Active gastroduodenal ulcer, wound or bone fracture
- At least one of the following laboratory values: Neutrophils <1500/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dL, total bilirubin > 1.5 N, alkaline phosphatase > 2.5 N (or > 5 N in case of hepatic involvement), serum creatinine > 1.5 N, 24 hr proteinuria > 1 g
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 |
|---|---|---|
| 5 FLUOROURACYLAlso: FLUOROURACILE EBEWEFolinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). The cycles will last 14 days. For this 1st line chemotherapy, the investigator has the choice of using capecitabine instead of LV5FU2; in this case the cycle lasts 21 days. | Drug | Experimental arm (de-escalation strategy -arm B), Standard arm (escalation strategy - arm A) |
| acide foliniqueAlso: ELVORINE200 mg/m² if Elvorine | Drug | Experimental arm (de-escalation strategy -arm B), Standard arm (escalation strategy - arm A) |
| irinotecanAlso: CAMPTOIrinotecan is administered IV at a dose of 180 mg/m² over 90 minutes. Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with irinotecan. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). The cycles will last 14 days. | Drug | Experimental arm (de-escalation strategy -arm B), Standard arm (escalation strategy - arm A) |
| OxaliplatinAlso: ELOXATINE 5 mg/mlOxaliplatin is administered IV at a dose of 85 mg/m² over 120 minutes. Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with oxaliplatin. The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2). The cycles will last 14 days. | Drug | Experimental arm (de-escalation strategy -arm B), Standard arm (escalation strategy - arm A) |
| capécitabineAlso: XELODAFor this 1st line chemotherapy, the investigator has the choice of using capecitabine instead of LV5FU2; in this case the cycle lasts 21 days. | Drug | Experimental arm (de-escalation strategy -arm B), Standard arm (escalation strategy - arm A) |
| bevacizumabAlso: AVASTINBevacizumab is administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy | Drug | Experimental arm (de-escalation strategy -arm B), Standard arm (escalation strategy - arm A) |
Primary outcome
The Primary Objective Was the Percentage of Patients Without Failure of the Strategy 16 Months After the Randomization.
Time frame: 16 months after randomization
The failure of the strategy is defined by the following events: * Progression (under certain condition) using RECIST version 1.1 and defined as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a nontarget lesion, or the appearance of new lesions * Death (all causes) * Toxicity leading to definitive stop of chemotherapy (oxaliplatine and/or irinotecan).
3 secondary outcomes
Best Response Rate (Using RECIST Version 1.1)
Time frame: At 16 months
Overall Survival (OS)
Time frame: Up to 3 years after the treatment start
Progression Free Survival (PFS)
Time frame: up to 24 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Jean Marc PHELIP, MD-PhD principal investigator
CHU St Etienne
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5 FLUOROURACYL, acide folinique and irinotecan in people with Colorectal Neoplasms, run by Federation Francophone de Cancerologie Digestive at 11 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 15 inclusion and 18 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: stopped early, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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?
Yes. Results are posted in the registry (first posted 10 Jul 2024). 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?
The Primary Objective Was the Percentage of Patients Without Failure of the Strategy 16 Months After the Randomization. (time frame: 16 months after randomization). 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 10 Jul 2024.