Rectal CancerPhase 2INOVANCT00865189
A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer
A Phase 2 study testing Bevacizumab, Oxaliplatin and Folinic Acid in people with Rectal Cancer, run by Hoffmann-La Roche at 40 sites in France.
Trial summary
This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Bevacizumab, Oxaliplatin and Folinic Acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 40 sitesFrance
- Study dates
- 23 Oct 2007to 23 Mar 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed locally advanced rectal cancer;
- measurable disease;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Who cannot join
- prior treatment with bevacizumab;
- prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
- previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
- history or evidence of central nervous system (CNS) disease;
- clinically significant cardiovascular disease;
- chronic treatment with high dose aspirin (more than [>] 325 milligrams per day [mg/day]) or non-steroidal anti-inflammatory drugs.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
France40 sites
ICO Paul Papin; Oncologie Medicale.
Angers, 49055
Study site
Angers, 49055
HOPITAL JEAN MINJOZ; Oncologie
Besançon, 25030
Study site
Besançon, 25030
Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale
Bordeaux, 33075
Study site
Bordeaux, 33075
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079
Study site
Dijon, 21079
Hopital Albert Michallon; Radiotherapie
La Tronche, 38700
Study site
La Tronche, 38700
Centre Oscar Lambret; Radiotherapie
Lille, 59020
Study site
Lille, 59020
Centre Hospitalier Andre Boulloche; Departement D'Oncologie
Montbéliard, 25209
Study site
Montbéliard, 25209
Centre Val Aurelle Paul Lamarque; Radiotherapie
Montpellier, 34928
Study site
Montpellier, 34928
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
Nancy, 54100
Study site
Nancy, 54100
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, 06189
Study site
Nice, 06189
Hopital Saint Louis; Radiotherapie Oncologie
Paris, 75475
Study site
Paris, 75475
Ch Pitie Salpetriere; Oncologie Medicale
Paris, 75651
Study site
Paris, 75651
HOPITAL TENON; Cancerologie Medicale
Paris, 75970
Study site
Paris, 75970
Ch Lyon Sud; Radiotherapie Sct Jules Courmont
Pierre-Bénite, 69495
Study site
Pierre-Bénite, 69495
Chu La Miletrie; Radiotherapie
Poitiers, 86021
Study site
Poitiers, 86021
Ico Rene Gauducheau; Oncologie
Saint-Herblain, 44805
Study site
Saint-Herblain, 44805
Centre Paul Strauss; Oncologie Medicale
Strasbourg, 67065
Study site
Strasbourg, 67065
Polyclinique Du Parc; Centre De Hautes Energies
Toulouse, 31078
Study site
Toulouse, 31078
Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie
Tours, 37044
Study site
Tours, 37044
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, 54511
Study site
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in Locally Advanced Resectable Rectal Cancer: A Randomized, Non-Comparative Phase II Study
This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).
- Conditions
- Rectal Cancer
- Being tested
- Bevacizumab, Oxaliplatin, Folinic Acid, 5-fluorouracil, Preoperative Radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes.
OxaliplatinDrug
Oxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m^2) as a 2-hour IV infusion.
Folinic AcidDrug
Folinic acid will be administered at a dose of 200 mg/m^2 as a 2-hour infusion.
5-fluorouracilDrug
5-fluorouracil will be administered at a dose of 400 mg/m^2 as an IV bolus, then at a dose of 600 mg/m^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2.
Preoperative RadiotherapyRadiation
Radiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days.
SurgeryProcedure or surgery
Radical rectal excision based on the TME technique.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | Experimental | In this arm, participants will undergo 3 phases of treatment. During the Phase 1, participants will receive induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (intravenous [IV] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 will be surgery involving a radical rectal excision using the total mesorectal excision (TME) technique. Receives: Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Folinic Acid; Drug: 5-fluorouracil; Radiation: Preoperative Radiotherapy; Procedure: Surgery |
| Arm B (Bevacizumab, Chemoradiotherapy) | Experimental | In this arm, participants will receive the Phase 2 and Phase 3 treatments only. The phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 will be surgery involving a radical rectal excision using the TME technique. Receives: Drug: Bevacizumab; Drug: 5-fluorouracil; Radiation: Preoperative Radiotherapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Tumor Sterilization Defined by ypT0-N0
Tumor sterilization was defined as the absence of residual tumor cells in the resected specimen including lymph nodes (ypT0-N0). The rate of sterilization of the tumoral specimen was assessed after surgery on the surgical specimen by local review. Analyses were performed for participants who have been operated as defined by the protocol (within the study and TME technique) and for all participants who have been operated. Reported is the percentage of participants with tumor sterilization.
Measured: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Secondary outcomes (10)
Percentage of Participants With Tumor Down-Staging (ypT0-pT2)
A participant with a downstaging was defined as a participant with T3 (T describes the size of the original [primary] tumor) at inclusion and T2 or T1 or T0 after surgery, or with N+ (N describes lymph nodes involvement) at inclusion and N- after surgery and if T is equal at inclusion and after surgery. The clinical tumor-node-metastasis (cTNM) classification was used at inclusion and the pathological staging tumor and nodes (ypTN) classification after surgery. Reported is the percentage of participants with tumor downstaging of the surgical specimen according to the local review and centralized review.
Measured: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Percentage of Participants With Local and Distant Recurrences
The percentage of participants with a recurrence was described by type of recurrence (local and distant recurrence).
Measured: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death
Measured: Baseline up to approximately 6 years
Disease-Free Survival (DFS)
The DFS was defined as the time from the first treatment intake to disease recurrence assessed (second primary cancer, local or distant recurrence, distant metastases) or death from any cause. The DFS was analyzed using Kaplan-Meier method.
Measured: From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)
Percentage of Participants Who Died
Measured: Baseline up to approximately 6 years
Overall Survival
The overall survival was defined as the time from the first treatment intake to death from any cause.
Measured: From the first treatment administration to the date of death (up to approximately 6 years)
Number of Cycles of Induction Chemotherapy
Measured: 6 cycles (12 weeks; cycle length = 14 days)
Number of Cycles of Chemotherapy
Measured: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Number of Cycles of Radiotherapy
Measured: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Percentage of Participants With Surgery
The surgery involving a radical rectal excision using the TME technique.
Measured: Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study start23 Oct 2007
- Primary completion23 Mar 2016
- Study completion23 Mar 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865189
- Sponsor's protocol ID
- ML19202
- Other IDs
- 2006-003472-35
- Acronym
- INOVA
- Status last verified
- Jul 2017
- First submitted
- 18 Mar 2009
- Last updated
- 4 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Borg C, Andre T, Mantion G, Boudghene F, Mornex F, Maingon P, Adenis A, Azria D, Piutti M, Morsli O, Bosset JF. Pathological response and safety of two neoadjuvant strategies with bevacizumab in MRI-defined locally advanced T3 resectable rectal cancer: a randomized, noncomparative phase II study. Ann Oncol. 2014 Nov;25(11):2205-2210. doi: 10.1093/annonc/mdu377. Epub 2014 Aug 13.
PubMed 25122693
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in Locally Advanced Resectable Rectal Cancer: A Randomized, Non-Comparative Phase II Study
- ClinicalTrials.gov ID
- NCT00865189
- Acronym / sponsor ID
- INOVA / ML19202
- Conditions
- Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2007 (actual)
- Primary completion
- 23 Mar 2016 (actual)
- Study completion
- 23 Mar 2016 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Posted 4 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) | Experimental | Drug: Bevacizumab, Drug: Oxaliplatin, Drug: Folinic Acid, Drug: 5-fluorouracil, Radiation: Preoperative Radiotherapy, Procedure: SurgeryIn this arm, participants will undergo 3 phases of treatment. During the Phase 1, participants will receive induction chemotherapy with 6 two-week cycles of bevacizumab + Folfox-4 (5-FU + oxaliplatin + folinic acid) for 12 weeks followed by a treatment-free interval of 3 to 4 weeks. The Phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (intravenous [IV] infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The Phase 3 will be surgery involving a radical rectal excision using the total mesorectal excision (TME) technique. |
| Arm B (Bevacizumab, Chemoradiotherapy) | Experimental | Drug: Bevacizumab, Drug: 5-fluorouracil, Radiation: Preoperative Radiotherapy, Procedure: SurgeryIn this arm, participants will receive the Phase 2 and Phase 3 treatments only. The phase 2 will include 7 weeks of bevacizumab + chemoradiotherapy (IV infusion of bevacizumab alone, 2 weeks before administration of the first cycle of chemoradiotherapy, then 5 one-week cycles of chemoradiotherapy [5-FU + radiotherapy], with administration of bevacizumab every two weeks [Cycles 1, 3 and 5]) followed by a treatment-free interval of 6 to 8 weeks. The phase 3 will be surgery involving a radical rectal excision using the TME technique. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- histologically confirmed locally advanced rectal cancer;
- measurable disease;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Key exclusion criteria (6 listed)
- prior treatment with bevacizumab;
- prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
- previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
- history or evidence of central nervous system (CNS) disease;
- clinically significant cardiovascular disease;
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 |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab will be administered at the fixed dose of 5 milligrams per kilogram (mg/kg) as an IV infusion over 30 to 90 minutes. | Drug | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy), Arm B (Bevacizumab, Chemoradiotherapy) |
| OxaliplatinOxaliplatin will be administered at a dose of 85 milligrams per square meter (mg/m^2) as a 2-hour IV infusion. | Drug | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) |
| Folinic AcidFolinic acid will be administered at a dose of 200 mg/m^2 as a 2-hour infusion. | Drug | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy) |
| 5-fluorouracil5-fluorouracil will be administered at a dose of 400 mg/m^2 as an IV bolus, then at a dose of 600 mg/m^2 as a continuous infusion for 22 hours in Phase 1, and will be administered at a dose of 225 mg/m^2 as a 24-hour infusion, 5 days a week, for 5 weeks in Phase 2. | Drug | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy), Arm B (Bevacizumab, Chemoradiotherapy) |
| Preoperative RadiotherapyRadiotherapy will be delivered in fraction of 1.8 gray per day (Gy/day), 5 days a week for 5 weeks, i.e., a total dose of 45 Gy will be administered in 25 fractions over a period of 33 days. | Radiation | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy), Arm B (Bevacizumab, Chemoradiotherapy) |
| SurgeryRadical rectal excision based on the TME technique. | Procedure or surgery | Arm A (Bevacizumab, Induction Chemotherapy, Chemoradiotherapy), Arm B (Bevacizumab, Chemoradiotherapy) |
Primary outcome
Percentage of Participants With Tumor Sterilization Defined by ypT0-N0
Time frame: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Tumor sterilization was defined as the absence of residual tumor cells in the resected specimen including lymph nodes (ypT0-N0). The rate of sterilization of the tumoral specimen was assessed after surgery on the surgical specimen by local review. Analyses were performed for participants who have been operated as defined by the protocol (within the study and TME technique) and for all participants who have been operated. Reported is the percentage of participants with tumor sterilization.
10 secondary outcomes
Percentage of Participants With Tumor Down-Staging (ypT0-pT2)
Time frame: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Percentage of Participants With Local and Distant Recurrences
Time frame: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)
Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death
Time frame: Baseline up to approximately 6 years
Disease-Free Survival (DFS)
Time frame: From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)
Percentage of Participants Who Died
Time frame: Baseline up to approximately 6 years
Overall Survival
Time frame: From the first treatment administration to the date of death (up to approximately 6 years)
Number of Cycles of Induction Chemotherapy
Time frame: 6 cycles (12 weeks; cycle length = 14 days)
Number of Cycles of Chemotherapy
Time frame: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Number of Cycles of Radiotherapy
Time frame: Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7
Percentage of Participants With Surgery
Time frame: Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25122693Borg C, Andre T, Mantion G, Boudghene F, Mornex F, Maingon P, Adenis A, Azria D, Piutti M, Morsli O, Bosset JF. Pathological response and safety of two neoadjuvant strategies with bevacizumab in MRI-defined locally advanced T3 resectable rectal cancer: a randomized, noncomparative phase II study. Ann Oncol. 2014 Nov;25(11):2205-2210. doi: 10.1093/annonc/mdu377. Epub 2014 Aug 13.
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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.
Clinical Trials study chair
Hoffmann-La Roche
40 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 Bevacizumab, Oxaliplatin and Folinic Acid in people with Rectal Cancer, run by Hoffmann-La Roche at 40 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 3 inclusion and 6 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 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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 4 Aug 2017). 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?
Percentage of Participants With Tumor Sterilization Defined by ypT0-N0 (time frame: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation 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 NCT00865189, 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 4 Aug 2017.