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

NCT ID: NCT02402972

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2022-02-28

Brief 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.

Conditions

Colorectal Cancer; Metastasis

Keywords

adjuvant chemotherapy; intraportal chemotherapy; prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IPC plus AC

patients treated with intraoperative intraportal chemotherapy (IPC) plus adjuvant chemotherapy (AC; mFOLFOX6).; IPC: During the operation, one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein within 5 minutes just before ligation.

AC: All patients received mFOLFOX6 adjuvant chemotherapy, consisting of a 2-h infusion of 85 mg/m2 oxaliplatin given simultaneously with a 2-h infusion of 400 mg/m2 LV, followed by a bolus of 400 mg/m2 5-FU, and then a continuous infusion of 2000 mg/m2 5-FU given on 2 consecutive days by intravenous pumping every 14 days for 12 cycles.[1] Adverse events were categorized according to National Cancer Institute Common Toxicity Criteria, version 3.0.

Group Type: EXPERIMENTAL

FUDR +oxaliplatin

Intervention Type: DRUG

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

Intervention Type: DRUG

Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU

AC

patients treated with adjuvant chemotherapy (AC; mFOLFOX6) alone after surgery; Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy, consisting of a 2-h infusion of 85 mg/m2 oxaliplatin given simultaneously with a 2-h infusion of 400 mg/m2 LV, followed by a bolus of 400 mg/m2 5-FU, and then a continuous infusion of 2000 mg/m2 5-FU given on 2 consecutive days by intravenous pumping every 14 days for 12 cycles.\[1\] Adverse events were categorized according to National Cancer Institute Common Toxicity Criteria, version 3.0.

Group Type: ACTIVE_COMPARATOR

oxaliplatin+Leucovorin+5-FU

Intervention Type: DRUG

Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU

Interventions

FUDR +oxaliplatin

IPC: one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein

Intervention Type: DRUG

oxaliplatin+Leucovorin+5-FU

Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU

Intervention Type: DRUG

Other Intervention Names

fluorodeoxyuridine (FUDR); Leucovorin (LV)

Eligibility Criteria

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 β-HCG) or breast-feeding

5. Known drug abuse/ alcohol abuse

6. Legal incapacity or limited legal capacity

7. Pre-existing peripheral neuropathy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Xu jianmin

OTHER

Sponsor Role: lead

Responsible Party

Xu jianmin

Deputy director of the colorectal cancer center, Fudan University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hong Jiang, MD

Role: STUDY_DIRECTOR

Fudan University

Locations

Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianmin Xu, MD

Role: CONTACT

Phone: 86-13764476150

Email: xujmin@aliyun.com

Facility Contacts

Wenju Chang, MD

Role: primary

Other Identifiers

82345432

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IICCAC

Identifier Type: -

Identifier Source: org_study_id