Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

Colon Cancer Clinical Trial

Official title:

A Randomized Controlled Clinical Trial to Investigate the Effect of Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02882269
• Other study ID #: CRSYM201608
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: August 24, 2016
• Last updated: August 28, 2016
• Start date: December 2016
• Est. completion date: December 2021

Study information

• Verified date: August 2016
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Yueming Sun, PhD
• Phone: 02568136026
• Email: jssym[@]vip.sina.com
• Is FDA regulated: No
• Health authority: China: Jiangsu Province Health Department
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival		3 years	No
Secondary	overall survival		3 years	No
Secondary	recurrence-free survival		3 years	No
Secondary	local recurrence rate		3 years	No
Secondary	length of postoperative hospital stay	Length of postoperative hospital stay is defined as a duration between surgery and first discharge. An expected average is 10 days.	30 days	No
Secondary	early complication rate	Early complication is defined as a complication that occurred between the finish of the surgery and postoperative day 30. Complications includes anastomotic leakage, anastomotic bleeding, chyle leakage, wound infection, pulmonary embolism, myocardial infarction et al.The Clavien-Dindo Classification of Surgical Complications will be applied to access the degree of severity of postoperative complications.	30 days	Yes
Secondary	operative time		1 day	No
Secondary	number of lymph nodes retrieved		1 day	No