A Multi-center Randomized Controlled Trial of Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer

Colorectal Cancer Clinical Trial

Official title:

A Multi-center Randomized Controlled Trial: Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02402972
• Other study ID #: IICCAC
• Secondary ID: 82345432
• Status: Recruiting
• Phase: Phase 3
• First received: March 20, 2015
• Last updated: March 25, 2015
• Start date: February 2015
• Est. completion date: February 2022

Study information

• Verified date: January 2015
• Source: Fudan University
• Contact: Jianmin Xu, MD
• Phone: 86-13764476150
• Email: xujmin[@]aliyun.com
• Is FDA regulated: No
• Health authority: Fudan university; Shanghai: China
• Study type: Interventional

Clinical Trial Summary

To investigate whether intraoperative intraportal chemotherapy combined with adjuvant chemotherapy as treatment could improve disease-free survival (DFS) in patients with curative colorectal cancer resection compared with adjuvant chemotherapy alone.

This is a prospective, blind (doctors who done outcome measures were masked), multi-center, 2-arm randomized controlled trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: February 2022
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age = 18 and = 75 years;

2. Primary tumor has undergone histologically confirmed colon adenocarcinoma; Colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin).

3. Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2007 revision of the International Union Against Cancer TNM staging system)

4. Performance status (ECOG) 0~1

5. Adequate hematological function: Neutrophils=1.5 x109/l and platelet count=100 x109/l; Hb =9g/dl (within 1 week prior to randomization)

6. Adequate hepatic and renal function: Serum bilirubin=1.5 x upper limit of normal (ULN), alkaline phosphatase =5x ULN, and serum transaminase (either AST or ALT) = 5 x ULN(within 1 week prior to randomization);

7. Written informed consent for participation in the trial.

Exclusion Criteria:

1. Previous exposure to prior cancer therapy (chemotherapy, radiotherapy or intervention therapy) for colon cancer.

2. Patients with known hypersensitivity reactions to any of the components of the study treatments.

3. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

4. Pregnancy (absence confirmed by serum/urine ß-HCG) or breast-feeding

5. Known drug abuse/ alcohol abuse

6. Legal incapacity or limited legal capacity

7. Pre-existing peripheral neuropathy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Metastasis

Intervention

Drug:
• FUDR +oxaliplatin
IPC: one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein
• oxaliplatin+Leucovorin+5-FU
Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Xu jianmin	Ruijin Hospital, The Second Affiliated Hospital of Harbin Medical University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause.	up to 5 year	No
Secondary	overall survival	OS was measured from the date of randomization to the date of death from any cause.	3 year and 5 year	No
Secondary	metastasis-free survival	MFS was defined as the time from randomization to metastasis if metastasis was the first event.	3 year and 5 year	No
Secondary	adverse events of Chemotherapy and IPC	toxicity (using NCI CTC 3.0) compared with mFOLFOX6 alone.	6 months	Yes