Neoadjuvant FOLFOXIRI Chemotherapy in Patients With Locally Advanced Colon Cancer

Phase 2

• Conditions: Colonic Neoplasms; Drug Therapy
• Interventions: Drug: FOLFOXIRI

• Registration Number: NCT03484195
• Lead Sponsor: China Medical University, China

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.

Study Timeline

• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-03-30
• Study Start: 2018-04-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFOXIRI	FOLFOXIRI	Patients received 4 cycles of neoadjuvant FOLFOXIRI chemotherapy before surgical resection.

Primary Outcome Measures

Name	Time	Method
The ratio of tumor downstaging to stage 0 and stage I	2 years	Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Liaoning Cancer Hospital; 🇨🇳 Shenyang, Liaoning, China