Phase 2
N=180
Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer
Rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02340949 ↗Enrolled (actual)
180
Serious AEs
33.9%
Results posted
May 2021
Primary outcome: Primary: Number of Patients Achieving Pathologic Complete Response (pCR). — 25; 9; 90; 56 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aflibercept (Drug); 5-Fluoruracil (Drug); Oxaliplatin (Drug); Leucovorin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Achieving Pathologic Complete Response (pCR). |
25; 9; 90; 56 | — |
| SECONDARY Number of Patients Achieving Pathological Parameters of Efficacy: R0 Resection, Tumor Regression Grade, and Circular Radial Margin Rate |
101; 60; 2; 2; 12; 3 | — |
| SECONDARY Number of Participants With Significant MRI Changes Post Intervention, as Defined by T Downstaging |
68; 46; 47; 19 | — |
| SECONDARY Number of Patients Reporting Adverse Events (AEs) |
115; 65; 0; 0; 83; 31 | — |
| SECONDARY Number of Patients Reporting Surgical Complications |
3; 1; 112; 64; 2; 0 | — |
| SECONDARY Disease Free Survival (DFS) Rate at 3 Years |
75.2; 81.5 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Signed and dated informed consent, and willing and able to comply with protocol requirement;
- Male or female subjects with rectal cancer ≥18 and 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 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);
- 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.
Data sourced from ClinicalTrials.gov (NCT02340949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.