Clinical trial NCT03484195: Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colonic Neoplasms
Drug Therapy
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The ratio of tumor downstaging to stage 0 and stage I
timeFrame: 2 years
Secondary outcomes:
measure: Tumor regression grade (TRG)
timeFrame: 2 years
measure: Disease free survival
timeFrame: 3 years
measure: Overall survival time
timeFrame: 3 years
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 3 years
measure: ctDNA change
timeFrame: 3 years
measure: SUVmax changes
timeFrame: At the begin of Cycle 1 and the end of Cycle 4 (each cycle is 14 days)
measure: Quality of life (QLQ C30)
timeFrame: Every 2 weeks after the first treatment until 3 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
Study officials:
affiliation: Cancer Hospital of China Medical University, Department of Medical Oncology, Liaoning Cancer Hospital & Institute
name: Jingdong Zhang
role: STUDY_CHAIR
References: