Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

NCT ID: NCT02882269

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2021-12-31

Brief Summary

A randomized controlled clinical trial to compare the short and long outcomes of Neoadjuvant chemotherapy with postoperative chemotherapy in patients with resectable locally advanced colon cancer

Detailed Description

For resectable locally advanced colon cancer, the preferred treatment is colectomy with en bloc removal of the regional lymph nodes followed by chemotherapy of about 6 months. However, surgery may postpone the administration of chemotherapy due to postoperative complications such as anastomosis leakage, abdominal infection, thus leads to a poor survival. Some scholars suggested that for patients with locally advanced colon cancer, chemotherapy given before surgery might shrink or downstage tumor, facilitate surgery and promote a better oncological outcome. Whether adjuvant chemotherapy benefits these patients with better outcome still remains controversial.

In this study, eligible patients will be randomly allocated to receive either adjuvant chemotherapy or not. For patients receiving adjuvant chemotherapy, surgery will be performed 3-4 weeks later. Preoperative and postoperative chemotherapy will be given for a total of about 6 months. For patients receiving no preoperative chemotherapy, chemotherapy will be given for about 6 months postoperatively. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Postoperative chemotherapy

Patients receive 6 months of chemotherapy after surgery.

Group Type: ACTIVE_COMPARATOR

Postoperative chemotherapy

Intervention Type: DRUG

Locally advanced colon cancer patients will receive surgery first, followed by 6 months of chemotherapy. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.

Neoadjuvant chemotherapy

Patients receive 3-4 cycles of chemotherapy before surgery. Preoperative and postoperative chemotherapy will be given for a total of 6 months.

Group Type: EXPERIMENTAL

Neoadjuvant chemotherapy

Intervention Type: DRUG

Neoadjuvant chemotherapy will be given to locally advanced colon cancer patients for 3-4 cycles. Surgery will be performed between 3 to 4 weeks subsequent to the last cycle of chemotherapy. After surgery, additional chemotherapy will be given. Preoperative and postoperative chemotherapy will be given for a total of 6 months. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.

Interventions

Postoperative chemotherapy

Locally advanced colon cancer patients will receive surgery first, followed by 6 months of chemotherapy. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.

Intervention Type: DRUG

Neoadjuvant chemotherapy

Neoadjuvant chemotherapy will be given to locally advanced colon cancer patients for 3-4 cycles. Surgery will be performed between 3 to 4 weeks subsequent to the last cycle of chemotherapy. After surgery, additional chemotherapy will be given. Preoperative and postoperative chemotherapy will be given for a total of 6 months. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.

Intervention Type: DRUG

Other Intervention Names

drug combination (FOLFOX, CapeOX or FOLFIRI) or Capecitabine monotherapy; drug combination (FOLFOX, CapeOX or FOLFIRI) or Capecitabine monotherapy

Eligibility Criteria

Inclusion Criteria

• Patients suitable for curative surgery between 18 to 80 years old;
• American Society of Anesthesiologists(ASA) grade I-III;
• Pathological diagnosis of adenocarcinoma;
• Tumor located between the cecum and sigmoid colon;
• Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
• Informed consent;
• No preoperative chemoradiotherapy;
• No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion Criteria

• Pregnant patient;
• History of psychiatric disease;
• Use of systemic steroids;
• Simultaneous multiple primary colorectal cancer;
• Preoperative imaging examination results show:

1. distant metastasis;

2. unable to perform R0 resection;

• Postoperative pathology of T1-T2 N0;
• History of any other malignant tumor in recent 5 years;
• Patients need emergency operation: mechanic ileus, perforation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fumin Zhang, Professor

Role: STUDY_DIRECTOR

Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital

Central Contacts

Yueming Sun, PhD

Role: CONTACT

jssym@vip.sina.com

02568136026

Other Identifiers

CRSYM201608

Identifier Type: -

Identifier Source: org_study_id