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New treatment option for Rectal Cancer
Official title Neoadjuvant mFOLFOXIRI Plus Bevacizumab in Patients With High-Risk Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT04215731
What this study is testing
What is Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab?
Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rectal cancer.
Also referred to as Oxaliplatin, Irinotecan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Multimodality treatment that comprises preoperative fluoropyrimidine with concurrent radiotherapy followed by total mesorectal excision (TME) surgery and adjuvant fluoropyrimidine-based chemotherapy is recommended as a standard treatment of patients with stage II/III rectal cancer. However, the main target of radiotherapy is local control but no improvement in disease-free survival (DFS) or overall survival (OS) has been shown with this treatment strategy, which leaves approximately 30% of patients in whom distant metastases will develop.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Willing and able to provide written informed consent.
- Male or female people \> 18 years \< 70 of age.
- Histological or cytological documentation of adenocarcinoma of the rectal (\<12 cm from the anal verge).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Evaluated by pelvic contrast-enhanced MRI as having high-risk locally advanced disease: cT3 with mesorectal fascia involvement, or cT4a/b, or...
You likely can't join if
- Evidence of distant metastasis (M1) confirmed by systemic CT, MRI, or PET-CT (at minimum including chest, abdomen, and pelvis).
- Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
- Complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.
- Tumor invasion into the small intestine, or presence of intestinal fistula (including but not limited to rectovesical or rectovaginal fistula), or...
- Previous or concurrent other active malignancies, except for malignancies treated with curative intent and disease-free for \>5 years, or adequately...
- Prior pelvic radiotherapy, or any anti-cancer therapy (chemotherapy, targeted therapy, hormonal therapy, immunotherapy, biologic therapy, etc.)...
See the full eligibility criteria
- Willing and able to provide written informed consent.
- Male or female people \> 18 years \< 70 of age.
- Histological or cytological documentation of adenocarcinoma of the rectal (\<12 cm from the anal verge).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Evaluated by pelvic contrast-enhanced MRI as having high-risk locally advanced disease: cT3 with mesorectal fascia involvement, or cT4a/b, or positive lateral lymph nodes (TNM staging reference provided).
- No prior systemic anti-cancer therapy for colorectal cancer, including cytotoxic drugs, immune checkpoint inhibitors, molecular targeted therapy, or endocrine therapy.
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment
- Willing and able to comply with the study protocol and visit schedule.
- Evidence of distant metastasis (M1) confirmed by systemic CT, MRI, or PET-CT (at minimum including chest, abdomen, and pelvis).
- Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
- Complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.
- Tumor invasion into the small intestine, or presence of intestinal fistula (including but not limited to rectovesical or rectovaginal fistula), or abscess.
- Previous or concurrent other active malignancies, except for malignancies treated with curative intent and disease-free for \>5 years, or adequately treated carcinoma in situ.
- Prior pelvic radiotherapy, or any anti-cancer therapy (chemotherapy, targeted therapy, hormonal therapy, immunotherapy, biologic therapy, etc.) within 12 months prior to enrollment.
- History of thromboembolic events within 12 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or deep vein thrombosis.
- Any of the following within 12 months prior to enrollment: myocardial infarction, severe/unstable angina, NYHA Class II or greater cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmia...
- Diagnosis of dMMR or MSI-High tumor by immunohistochemistry or PCR testing.
- Current or within 2 weeks prior to enrollment: therapeutic antiplatelet therapy or high-dose anticoagulant therapy.
- Major surgery (e.g., laparotomy, thoracotomy, visceral resection via laparoscopy) or severe trauma within 2 months prior to enrollment (except for colostomy performed prior to enrollment; surgical incision must be fully...
- Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Presence of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia, aneurysm, coagulation disorders, etc.).
- Untreated active hepatitis (Hepatitis B, defined as HBV-DNA ≥500 IU/mL; Hepatitis C, defined as HCV-RNA above the lower limit of detection of the assay) or co-infection with HBV and HCV.
- people with known allergy to the study drugs or to any of its excipients.
- Breast- feeding or pregnant women.
- Any other severe physical or mental illness or abnormal laboratory finding that may increase the risk associated with study participation, interfere with study results, or make the patient unsuitable for the study in...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.