NCT03391843Active, not recruitingPhase 2
Neoadjuvant Chemotherapy Combined With Cetuximab for EGFR Wild Type Locally Advanced Rectal Cancer
FOLFOXIRI Combined With Cetuximab as a Neoadjuvant Chemotherapy for EGFR Wild Type Locally Advanced Rectal Cancer:A Phase II Study
Source: ClinicalTrials.gov · Last updated 5 Jan 2018
Brief summary (registry, in English)
A number of pilot studies had shown high rate of complete resection after neoadjuvant chemotherapy alone for local advanced rectal cancer(LARC), but they did not increase the ratio of pathological complete response (pCR) which was associated with improvement of overall survival (OS). On the other hand,some clinical trials show that triple active cytotoxic agents (Fluorouracil, Oxaliplatin, Irinotecan, FOLFOXIRI) combined with cetuximab for EGFR wild type metastatic colorectal cancer had more effective than double agents.Therefore,a hypothesis is the FOLFOXIRI+Cetuximab as the neoadjuvant chemotherapy regimen might improve the patient's ratio of pCR.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 2 Jan 2018
- Start date
- 1 Dec 2017
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT03391843
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 1 Dec 2017 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient had received pelvic radiotherapy;
- Patient had received systemic chemotherapy
- Uncontrolled co-morbid illnesses or other concurrent disease
Other illness
- Had metastatic disease
- Patient had second malignant disease within 5 years
Other
- Pregnant and Nursing women
- Patients refused to signed informed consent.
Who the study is looking for
- Age ≥ 18 to 75 years at diagnosis
- Diagnosis of rectal adenocarcinoma
- ECOG status: 0～1
- Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2)
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
- 1),Leukocytes ≥ 3.0 x109/ L, 2),Absolute neutrophil count (ANC) ≥ 1.5 x109/ L 3),Platelet count ≥ 100 x109/ L, 4),Hemoglobin (Hb) ≥ 9g/ dL. 5),Total bilirubin ≤1.5 x the upper limit of normal (ULN). 6),Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 x ULN. 7),Serum creatinine ≤ 1.5 x the ULN. 8),Signed informed consent;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Radiation Oncology,Renji Hospital affiliated to Medical School, Shanghai Jiaotong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.