Rectal CancerPhase 2RIANCT02340949

Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer

A Phase 2 study testing Aflibercept, 5-Fluoruracil and Oxaliplatin in people with Rectal Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial compares induction treatment with FOLFOX with or without aflibercept in a high risk population selected by MRI, prior to receiving standard chemoradiation (capecitabine combined with 50.4 Gy in 28 days) and surgery, in order to evaluate the efficacy in terms of pathologic complete response (pCR). Read more about this study

Who is it for?: Ages 18 to 69 years
Conditions the study is for: Rectal Cancer
What is being tested?: Aflibercept, 5-Fluoruracil and Oxaliplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: No sites listed yet
Study dates: Jan 2015to 4 Feb 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 to 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed and dated informed consent, and willing and able to comply with protocol requirement;
Male or female subjects with rectal cancer ≥18 and <70 years of age;
High risk MRI-defined operable rectal cancer (with an inferior margin no more than 12 cm above the anal verge as assessed by MRI). Presence of at least 1 of the following on high resolution, thin-slice MRI (3 mm):
Middle Third Tumors
mr T3
Extramural vascular invasion (EMVI) positive

Show all 23Show fewer

Extramural extension > 5 mms into perirectal fat
Mesorectal fascia (MRF) threatened or involved*
mr T4***
Distal Third Tumors (≤5 cm from anal verge)
mr T3 tumor at or below levators
T4 as above N2**
tumor or lymph node < 1 mm from the mesorectal fascia **≥4 lymph nodes in the mesorectum showing morphological signs on MRI indicating metastatic disease. ≥4 nodes, whether enlarged or not, with a rounded, homogeneous appearance is thus not sufficient.
T4a: overgrowth to an adjacent organ or structure or T4b: peritoneal involvement.
Histologically confirmed adenocarcinoma of the rectum. All other histological types are excluded;
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤1;
Hematological status: neutrophils (ANC) ≥1.5x109/L; platelets ≥100x109/L; hemoglobin ≥9g/dL;
Adequate renal function: serum creatinine level <1.5 x upper limit of normality (ULN);
Adequate liver function: serum bilirubin ≤1.5 x ULN, alkaline phosphatase <5x ULN, AST/ALT < 3 x ULN;
Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour;
Regular follow-up feasible;
For female patients of childbearing potential, negative serum pregnancy test within 1 week (7 days) prior to starting study treatment;
Female patients must commit to using reliable and appropriate methods of contraception until at least three months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another contraceptive method during the trial.

Who cannot join

Prior treatment with aflibercept;
History or evidence upon physical examination of metastasis;
Uncontrolled hypercalcemia;
Pre-existing permanent neuropathy (NCI grade ≥2);
Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy;
Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy);

Show all 13Show fewer

Treatment with any other investigational medicinal product within 28 days prior to study entry;
Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years;
Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days;
Pregnant or breastfeeding women;
Patients with known allergy to any excipient to study drugs;
History of myocardial infarction and/or stroke within 6 months prior to randomization; Previous history of stable angina, uncontrolled arrhythmia, and acute coronary syndrome even if controlled with medication or with myocardial infarction within the last 12 months.
Bowel obstruction.

About this study

Official title: Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer. Phase II Randomized, Multicenter, Open Label Trial

Read the detailed description

This is a randomized trial comparing induction treatment with FOLFOX with or without aflibercept in a high risk population selected by MRI, prior to receiving standard chemoradiation (capecitabine combined with 50.4 Gy in 28 days) and surgery. Once it is confirmed that the subjects fulfill the eligibility criteria (MRI-defined high risk RC), and have signed the informed consent, a central review will be requested to confirm clinical stage, and then they will be randomized to receive mFOLFOX6 + Aflibercept or mFOLFOX6 (without Aflibercept).

Random assignment of treatment will be stratified by T3 versus T4 stage. All the patients enrolled in the study will receive one cycle of study medication (mFOLFOX6 with or without aflibercept) every 14 days for six cycles, unless unacceptable toxicity or progression is detected. After this treatment, patients will receive standard chemo-radiotherapy (CT/RT) (capecitabine 825 mg/m2 twice daily combined with a total dose of 50.4 Gy in 28 days) followed by surgery, provided they have not progressed.

Patients with progression disease during the treatment phase will be withdrawn from the study and will receive their treatment according to the investigator's judgment. If a patient withdraws consent and refuses to receive further treatment, the patient must be followed up for 3 years from randomization or until progression, to evaluate disease-free survival. If a patient withdraws consent and refuses to continue in the study, the follow-up evaluations must be discontinued.

Conditions: Rectal Cancer
Being tested: Aflibercept, 5-Fluoruracil, Oxaliplatin, Leucovorin
Medical subject headings: Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AfliberceptDrug
Also called ZALTRAP
Administered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml
5-FluoruracilDrug
Also called 5-FU
Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2
OxaliplatinDrug
Also called Any marketed
Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU
LeucovorinDrug
Also called Any marketed
Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU

Study groups in NCT02340949
Study group	Role	What they receive
mFOLFOX6 + Aflibercept	Experimental	- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme: Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m². - Aflibercept, will be administered intravenously (I.V.) at doses of 4 mg/Kg on Day 1 every 14 days. Aflibercept will be supplied to sites by the study Sponsor as 4 ml vials at a concentration of 25 mg/ml. Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs. Receives: Drug: Aflibercept; Drug: 5-Fluoruracil; Drug: Oxaliplatin; Drug: Leucovorin
mFOLFOX6	Active comparator	- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme: Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m². Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs. Receives: Drug: 5-Fluoruracil; Drug: Oxaliplatin; Drug: Leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Achieving Pathologic Complete Response (pCR).
The number of patients achieving pCR after induction therapy with mFOLFOX6 +/- aflibercept followed by chemotherapy (CT)/radiotherapy (RT). pCR will be defined as the absence of viable tumor cells in the primary tumor and in the lymph nodes (T0N0)
Measured: From baseline until 2 years and 2 months

Secondary outcomes (5)

Number of Patients Achieving Pathological Parameters of Efficacy: R0 Resection, Tumor Regression Grade, and Circular Radial Margin Rate
R0 resection is defined as complete tumor removal, and correlates with good prognosis.
Tumor regression grade (TRG) is defined as presence of residual tumor after preoperative therapy. This was assessed by magnetic resonance imaging (MRI) according to the 5-point regression grading scale established by Mandard: TRG1 (complete response with no residual cancer), TRG2 (rare residual cancer), TRG3 (fibrosis outgrowing residual cancer), TRG4 (residual cancer outgrowing fibrosis) and TRG5 (absence of regression).
Circular Radial Margin (CRM) is defined as the distance from the margin of normal tissue to the edge of tumor tissue in the resected primary tumor the measured by histopathology study after surgery. A margin of ≤1 mm is considered to be a negative prognostic factor for local recurrence.
Measured: From baseline until 2 years and 2 months
Number of Participants With Significant MRI Changes Post Intervention, as Defined by T Downstaging
Tumor size is assessed by MRI to determine the T stage. T Downstaging: defined as a lower pathologic T stage compared to pre-treatment T stage.
Measured: From baseline until 2 years and 2 months
Number of Patients Reporting Adverse Events (AEs)
The safety and tolerability of the study therapy were assessed by means of AEs and changes in laboratory data. AEs were coded and evaluated using the NCI-CTCAE v4.0 toxicity criteria (if NCI-CTCAE are not applicable, MedDRA was used).
Measured: From baseline until 2 years and 2 months
Number of Patients Reporting Surgical Complications
Surgical complications will be assessed by means of AEs reported during 30 days post surgery.
Measured: From surgical intervention up to 30 days post-surgery, within a general time frame of 2 years and 2 months per study protocol
Disease Free Survival (DFS) Rate at 3 Years
DFS rate is defined as the percentage of participants without local recurrences at 3-years post study treatment. Here we report the DFS rate at 3-years after completing the Study treatment.
Measured: At 3 years after study treatment completion, within a general time frame of 5 years and two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 20154 Feb 2020

First posted19 Jan 2015 (estimated)
Study startJan 2015
Primary completion15 Jul 2019
Study completion4 Feb 2020

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.
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: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02340949
Sponsor's protocol ID: GEMCAD-1402
Acronym: RIA
Status last verified: Apr 2021
First submitted: 9 Jan 2015
Last updated: 3 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Fernandez-Martos C, Pericay C, Losa F, Garcia-Carbonero R, Layos L, Rodriguez-Salas N, Martin-Richard M, Alonso-Orduna V, Vera R, Gallego J, Capdevila J, Salud A, Nogue M, Maurel J, Guash I, Montagut C, Lopez C, Macias I, Jain RK, Garcia-Albeniz X. Effect of Aflibercept Plus Modified FOLFOX6 Induction Chemotherapy Before Standard Chemoradiotherapy and Surgery in Patients With High-Risk Rectal Adenocarcinoma: The GEMCAD 1402 Randomized Clinical Trial. JAMA Oncol. 2019 Nov 1;5(11):1566-1573. doi: 10.1001/jamaoncol.2019.2294.
PubMed 31465088

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer. Phase II Randomized, Multicenter, Open Label Trial
ClinicalTrials.gov ID: NCT02340949
Acronym / sponsor ID: RIA / GEMCAD-1402
Conditions: Rectal Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Grupo Espanol Multidisciplinario del Cancer DigestivoUniversity, hospital or other
Collaborators: Pivotal S.L.
Study start: Jan 2015
Primary completion: 15 Jul 2019 (actual)
Study completion: 4 Feb 2020 (actual)
First posted: 19 Jan 2015 (estimated)
Results: Posted 3 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
mFOLFOX6 + Aflibercept	Experimental	Drug: Aflibercept, Drug: 5-Fluoruracil, Drug: Oxaliplatin, Drug: Leucovorin- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme: Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m². - Aflibercept, will be administered intravenously (I.V.) at doses of 4 mg/Kg on Day 1 every 14 days. Aflibercept will be supplied to sites by the study Sponsor as 4 ml vials at a concentration of 25 mg/ml. Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.
mFOLFOX6	Active comparator	Drug: 5-Fluoruracil, Drug: Oxaliplatin, Drug: Leucovorin- mFOLFOX-6 scheme: 5-Fluoruracil [5-FU], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme: Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m². Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.

Who may qualify

Ages: 18 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Signed and dated informed consent, and willing and able to comply with protocol requirement;
Male or female subjects with rectal cancer ≥18 and <70 years of age;
High risk MRI-defined operable rectal cancer (with an inferior margin no more than 12 cm above the anal verge as assessed by MRI). Presence of at least 1 of the following on high resolution, thin-slice MRI (3 mm):
Middle Third Tumors
Distal Third Tumors (≤5 cm from anal verge)

Key exclusion criteria (13 listed)

Prior treatment with aflibercept;
History or evidence upon physical examination of metastasis;
Uncontrolled hypercalcemia;
Pre-existing permanent neuropathy (NCI grade ≥2);
Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy;

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
AfliberceptAlso: ZALTRAPAdministered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml	Drug	mFOLFOX6 + Aflibercept
5-FluoruracilAlso: 5-FUOnce every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2	Drug	mFOLFOX6, mFOLFOX6 + Aflibercept
OxaliplatinAlso: Any marketedOnce every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU	Drug	mFOLFOX6, mFOLFOX6 + Aflibercept
LeucovorinAlso: Any marketedOnce every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU	Drug	mFOLFOX6, mFOLFOX6 + Aflibercept

Primary outcome

Number of Patients Achieving Pathologic Complete Response (pCR).
Time frame: From baseline until 2 years and 2 months
The number of patients achieving pCR after induction therapy with mFOLFOX6 +/- aflibercept followed by chemotherapy (CT)/radiotherapy (RT). pCR will be defined as the absence of viable tumor cells in the primary tumor and in the lymph nodes (T0N0)

5 secondary outcomes

Number of Patients Achieving Pathological Parameters of Efficacy: R0 Resection, Tumor Regression Grade, and Circular Radial Margin Rate
Time frame: From baseline until 2 years and 2 months
Number of Participants With Significant MRI Changes Post Intervention, as Defined by T Downstaging
Time frame: From baseline until 2 years and 2 months
Number of Patients Reporting Adverse Events (AEs)
Time frame: From baseline until 2 years and 2 months
Number of Patients Reporting Surgical Complications
Time frame: From surgical intervention up to 30 days post-surgery, within a general time frame of 2 years and 2 months per study protocol
Disease Free Survival (DFS) Rate at 3 Years
Time frame: At 3 years after study treatment completion, within a general time frame of 5 years and two months

Results and safety

Results posted to the registry on 3 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
mFOLFOX6 + Aflibercept	115	99
mFOLFOX6	65	61

Primary outcome: Number of Patients Achieving Pathologic Complete Response (pCR).

Time frame: From baseline until 2 years and 2 months. Count of participants. Unit: Participants

Measure	mFOLFOX6 + Aflibercept n = 115	mFOLFOX6 n = 65
Yes	25	9
No	90	56

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline to study completion, within an general time frame of 3 years per study protocol. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
mFOLFOX6 + Aflibercept	45 of 115 (39.1%)	115 of 115 (100%)	12 of 115
mFOLFOX6	16 of 65 (24.6%)	65 of 65 (100%)	7 of 65

Limitations and caveats (from the sponsor): There are no overall limitations and caveats. In detail: There were 6 patients that received treatment doses that did not matched protocol specifications. These were notified as protocol major deviations to the competent authorities and ethics committees. The effect of these deviations on results is not significant.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31465088Fernandez-Martos C, Pericay C, Losa F, Garcia-Carbonero R, Layos L, Rodriguez-Salas N, Martin-Richard M, Alonso-Orduna V, Vera R, Gallego J, Capdevila J, Salud A, Nogue M, Maurel J, Guash I, Montagut C, Lopez C, Macias I, Jain RK, Garcia-Albeniz X. Effect of Aflibercept Plus Modified FOLFOX6 Induction Chemotherapy Before Standard Chemoradiotherapy and Surgery in Patients With High-Risk Rectal Adenocarcinoma: The GEMCAD 1402 Randomized Clinical Trial. JAMA Oncol. 2019 Nov 1;5(11):1566-1573. doi: 10.1001/jamaoncol.2019.2294.
Individual participant dataSharing planned: No

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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.

Carlos Fernández-Martos, MD study director

Fundación Instituto Valenciano de Oncología

Antonieta Salud Salvia, MD principal investigator

Hospital Universitari Arnau de Vilanova de Lleida

Carles Pericay Pijaume, MD principal investigator

Hospital de Sabadell - Parc Taulí

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aflibercept, 5-Fluoruracil and Oxaliplatin in people with Rectal Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo.

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 23 inclusion and 13 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 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

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 3 May 2021). 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?

Number of Patients Achieving Pathologic Complete Response (pCR). (time frame: From baseline until 2 years and 2 months). 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 NCT02340949, 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 3 May 2021.