Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer

Colonic Neoplasms Clinical Trial

Official title:

Neoadjuvant FOLFOXIRI (Irinotecan, Oxaliplatin and Fluorouracil) Chemotherapy in Patients With Locally Advanced Colon Cancer：an Open-label, Single-arm, Multicenter Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03484195
• Other study ID #: LGIOG-2017-01
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2021
• Source: China Medical University, China
• Contact: Jingdong Zhang
• Phone: +86-13804027878
• Email: zhangjingdong[@]cancerhosp-ln-cmu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer.

Description:

For the patients with locally advanced colon cancer, adjuvant FOLFOX and XELOX chemotherapy have become standard treatment. However, 30% - 40% patients suffered from local recurrence or distant metastasis after this standard treatment. Neoadjuvant chemotherapy could shrink tumors, eliminate micrometastasis, reduce surgical trauma and accelerate recovery. Hence, we evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy in treating patients with locally advanced colon cancer.

In this prospective study, 30 patients with locally advanced colon cancer will be treated with 4 cycles of neoadjuvant FOLFOXIRI chemotherapy followed by surgical resection. PET-CT scanning will be performed before and after the neoadjuvant FOLFOXIRI chemotherapy to assess SUVmax changes. The ctDNA in peripheral blood before and after each cycle of neoadjuvant FOLFOXIRI chemotherapy will be detected. In the course of treatment, safety evaluation will be carried out according to adverse reaction classification (CTCAE) 4. 0.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Age: 18-75years old

• Primary and pathological diagnosis of colon adenocarcinoma

• Radiographic evaluation of initial resectable colon cancer

• T4b colon cancer

• ECOG status: 0~1

• Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:

Neutrophil count=1.5×10^9/L Platelet count=90×10^9/L Hemoglobin=90g/L Total bilirubin (TBI) = 1.5 * ULN Alanine aminotransferase (ALT)=2.5 * ULN Aspartate aminotransferase (AST)=2.5 * ULN Alkaline phosphatase (ALP)=2.5 * ULN

• Signed informed consent; able to comply with study and/or follow- up procedures

Exclusion Criteria:

• Previous treatment with oxaliplatin, irinotecan or fluorouracil

• Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.

• With distant metastasis

• Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia uncontrolled hypertension. Unexplained syncope occurred within 3 months

• Digestive system diseases that would preclude study treatment or follow-up within the past 6 months

• Gastric ulcers or duodenal ulcers for the treatment of resistance;

• 3 or 4 grade gastrointestinal bleeding / bleeding;

• Gastrointestinal perforation / fistula;

• abdominal abscess;

• Infectious or inflammatory bowel disease

• HIV infection and/or active hepatitis B virus infection

• Pregnant or lactating women. Fertile patients must use effective contraception

• Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study

• Other intervention clinical trials were combined at the same time.

• Nerve or mental abnormality affecting cognitive ability

• Other malignancy except effectively treated squamous cell or basal cell skin cancer,

• Other situations that the researchers think should be excluded

Related Conditions & MeSH terms

• Colonic Neoplasms
• Drug Therapy

Intervention

Drug:
• FOLFOXIRI
Irinotecan 150 mg/m^2 IV over 1h, day 1 + Oxaliplatin 85 mg/m^2 IV over 2h, day 1 + L-Leucovorin 200 mg/m^2 IV over 2h, day 1 + 5-Fluorouracil 2800 mg/m^2 IV 48h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months)

Locations

Country	Name	City	State
China	Liaoning Cancer Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ratio of tumor downstaging to stage 0 and stage I	Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I	2 years
Secondary	Tumor regression grade (TRG)	The level of tumor regression under pathological examination	2 years
Secondary	Disease free survival	Estimated from the date of surgery to the date of recurrence	3 years
Secondary	Overall survival time	Estimated from the date of enrollment to death from any cause	3 years
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	The grade of toxicity will be assessed using the NCI-CTCAE version 4.0	3 years
Secondary	ctDNA change	The relationship between ctDNA and survival will be evaluated	3 years
Secondary	SUVmax changes	Tumor metabolic response through FDG-PET examination before and after 4 cycles of neoadjuvant FOLFOXIRI chemotherapy	At the begin of Cycle 1 and the end of Cycle 4 (each cycle is 14 days)
Secondary	Quality of life (QLQ C30)	Scores according to EORTC QLQ-C30 scoring manual	Every 2 weeks after the first treatment until 3 years