Neoadjuvant Chemotherapy Combined With Cetuximab for EGFR Wild Type Locally Advanced Rectal Cancer

Rectal Cancer Stage III Clinical Trial

Official title:

FOLFOXIRI Combined With Cetuximab as a Neoadjuvant Chemotherapy for EGFR Wild Type Locally Advanced Rectal Cancer:A Phase II Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03391843
• Other study ID #: 2018CRC R-002
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 2, 2018
• Last updated: January 2, 2018
• Start date: December 1, 2017
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2018
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a multicenter, phase II trial to assess the efficacy and safety of triplet regimen (FOLFOXIRI) combined with cetuximab for patients with EGFR wild type LARC. After 4 cycles of FOLFOXIRI+cetuximab and 2 weeks later, the patients will be evaluated by senior radiologist, oncologist and surgeon through pelvic MRI, CT and Positron Emission Computed Tomography (PET-CT). The patients will go to surgery (TME) if the tumor response is good enough to have complete resection under the decision of the multidisciplinary team (MDT),otherwise, the patients will receive pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625 mg/m²,bid po,d1-5,qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m², bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME. All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME.

FOLFOXIRI+Cetuximab Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h + Cetuximab 500 mg/m²,all on day 1 of each 2 weeks cycle for 4-6 cycles,

Other Names:

CPT11，CAMPTO Eloxatin Xelod Erbitux

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age = 18 to 75 years at diagnosis

2. Diagnosis of rectal adenocarcinoma

3. ECOG status: 0~1

4. Clinical stage II (T3-4, N0) or stage III (T1-4, N1-2)

5. 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;

Exclusion Criteria:

1. Patient had received pelvic radiotherapy;

2. Patient had received systemic chemotherapy

3. Pregnant and Nursing women

4. Had metastatic disease

5. Uncontrolled co-morbid illnesses or other concurrent disease

6. Patient had second malignant disease within 5 years

7. Patients refused to signed informed consent.

Related Conditions & MeSH terms

• Rectal Cancer Stage III
• Rectal Neoplasms

Intervention

Drug:
• FOLFOXIRI+Cetuximab regimen
FOLFOXIRI+Cetuximab Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h +Cetuximab 500mg/m²,all on day 1 of each 2 weeks cycle

Locations

Country	Name	City	State
China	Department of Radiation Oncology,Renji Hospital affiliated to Medical School, Shanghai Jiaotong University	Shanghai	S

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic complete resection rate	Pathologic confirmation	Up to 10 weeks
Secondary	The rate of local control	Imaging diagnosis	3 years
Secondary	Disease free survival (DFS)	Imaging diagnosis	Three years
Secondary	Overall survival	Record document	Three years
Secondary	The rate of receive chemoradiation	Record document	Up to 10 weeks
Secondary	The rate of clinical complete response after 4 cycles of FOLFOXIRI	Pathologic confirmation	Up to 10 weeks
Secondary	The incidence of >=3 grade adverse events	Common Terminology Criteria for Adverse Events v3.0 (CTCAE)	Two years