Intraoperative Intraportal Chemotherapy Combined With Adjuvant Chemotherapy for Stage II and III Colorectal Cancer

Xu jianmin

Status and phase: Unknown; Phase 4

Conditions: Liver Neoplasms; Neoplasm Metastasis; Colorectal Neoplasms

Treatments: Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6); Drug: 5-FU and oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01972503

Octree Study

Details and patient eligibility

About

In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis in patients receiving curative colorectal cancer resection.

Full description

In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis and improve survival in patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation.

Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms.Arm A: 5-FU 1g and oxaliplatin 100mg + curative resection (study group, n=132). Arm B: curative resection alone (control group, n=132).Follow-up: X-ray, US, CT, blood test, colonoscopy,every 3months.

The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Age ≥ 18 and ≤ 75 years and with histologically proven adenocarcinoma of the colon or rectum
2. WHO performance status of 0 or 1
3. Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan
4. Written informed consent for participation in the trial.

Exclusion criteria

1. has prior other malignant cancer
2. has severe major organ dysfunction
3. has prior cancer therapy before surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

ARM A

Experimental group

Description:

Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In ARM A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg + curative resection+mFOLFOX6.

Treatment:

Drug: 5-FU and oxaliplatin

Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)

ARM B

Active Comparator group

Description:

Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In arm B, patients accepted curative resection + mFOLFOX6 alone.

Treatment:

Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)