A Phase 2/3 interventional study of Postoperative chemotherapy and Neoadjuvant chemotherapy in Colon Cancer, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-30.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2/3, Interventional, and Treatment
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
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 400 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
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Exclusion Criteria:
Preoperative imaging examination results show:
Patients receive 6 months of chemotherapy after surgery.
Drug: Postoperative chemotherapy
Patients receive 3-4 cycles of chemotherapy before surgery. Preoperative and postoperative chemotherapy will be given for a total of 6 months.
Drug: Neoadjuvant 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.
Also known as: drug combination (FOLFOX, CapeOX or FOLFIRI) or Capecitabine monotherapy
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.
Also known as: drug combination (FOLFOX, CapeOX or FOLFIRI) or Capecitabine monotherapy
disease-free survival
Time frame: 3 years
overall survival
Time frame: 3 years
recurrence-free survival
Time frame: 3 years
local recurrence rate
Time frame: 3 years
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.
Time frame: 30 days
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.
Time frame: 30 days
operative time
Time frame: 1 day
number of lymph nodes retrieved
Time frame: 1 day
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University