Clinical trial NCT02882269: Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer
Official title: A Randomized Controlled Clinical Trial to Investigate the Effect of Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Colon Cancer
Keywords: locally advanced colon cancer
neoadjuvant chemotherapy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 3 years
measure: recurrence-free survival
timeFrame: 3 years
measure: local recurrence rate
timeFrame: 3 years
measure: length of postoperative hospital stay
timeFrame: 30 days
measure: early complication rate
timeFrame: 30 days
measure: operative time
timeFrame: 1 day
measure: number of lymph nodes retrieved
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
name: Fumin Zhang, Professor
role: STUDY_DIRECTOR
References: