Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Capecitabine

Oxaliplatin

Antimetabolites

Cola

Subjects will receive systemic CapeOX chemotherapy both before and after the radical surgery for at most 4 cycles respectively. They shall have rest after the surgery for at least four weeks before the post-operative chemotherapy. CapOX regimen will be administered as follows:

1. Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1
2. Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14
3. Repeat every 3 weeks (Q3W)

capecitabine plus oxaliplatin before and after surgery

Subjects will first receive radical surgery, then have rest for at least four weeks. Thereafter, subjects will receive systemic CapeOX chemotherapy for at most 8 cycles. CapOX regimen will be administered as follows:

1. Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1
2. Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14
3. Q3W

capecitabine plus oxaliplatin after surgery

Sanjun Cai, M.D

Ye Xu, M.D

Adjuvant chemotherapy has been widely adopted worldwide for locally advanced colon cancer. However, more and more studies have found better efficacy and potential advantages of perioperative or neoadjuvant chemotherapy. The sooner the systemic chemotherapy is received, the better suppression it has on activity of tumor growth factors. Pre-operative chemotherapy may eliminate tiny metastases. It may also shrink the invasion of tumor before surgery, and thus reducing operational trauma and expediting recovery. With advances in radiology and tomography, staging before surgery is accurate enough to identify risks and prognosis for patients. The phase II trial conducted by our department has yielded encouraging results (N=47, CapeOX regimen, clinicaltrials.gov NCT02415829): after the neoadjuvant chemotherapy, no subject had disease progression, 68.1% subjects reached complete or partial response. Besides, the toxicity of neoadjuvant CapeOX chemotherapy was acceptable. The present randomized controlled phase III trial will be conducted to further compare efficacy and safety of the neoadjuvant and adjuvant CapeOX chemotherapy for patients with locally advanced resectable colon cancer in China. This study may have two periods, each will last for approximately 5 years. After the first period (n=994), if the results of the test group are better than the control group, the study will be terminated. Otherwise, the study will enter into period 2 (n=376) through selecting out genetically sensitive subjects and repeating the same trial process as period 1.

Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial

Defined as the length of time from the date of randomization until the first documented date of progression or death from any cause, whichever comes first

Defined as the rate of patients whose tumors are completely resected with all the margins being negative

Defined as the TRG staging of tumor after surgery

Defined as the length of time from randomization date until the date of death from any cause

Defined as the length of time from the date of randomization until the first documented date of relapse.

Fudan University

Professor, Chief physician

Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.

3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.

Anders Jakobsen, DMSc

Henrik Jensen, MD, PhD

Olav Dahl, MD

Göran Carlsson, MD

The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy + operation with the standard treatment of locally advanced colon cancer, which is operation + 8 cycles of (adjuvant) chemotherapy.

Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.

Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer

Vejle Hospital

Toripalimab union CAPEOX scheme： Toripalimab 240mg, ivgtt, Q3w Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w

Toripalimab

Ye Feng, Master

Ye feng, Master

According to the 2019NCCN guidelines, immunocheckpoint inhibitors are recommended for first-line treatment of metastatic colon cancer patients with high microsatellite instability (msi-h) or mismatched gene deletion (dMMR) who are not suitable for intensive treatment, and for all patients with second-line or above msi-h /dMMR treatment.This study is a single-center, single-arm phase II study of the use of triplezumab (JS001) combined with CAPEOX regimen in the neoadjuvant therapy of msi-h /dMMR for locally advanced colon cancer. The subjects received neoadjuvant therapy with triplezumab (JS001) combined with CAPEOX regimen, with one treatment cycle every 3 weeks and two cycles of surgery followed by pathological evaluation.

Triplezumab Combined With CAPEOX Regimen in Neoadjuvant Therapy for Locally Advanced Colon Cancer

Triplezumab Combined With CAPEOX Regimen Was Used in a Phase II Clinical Study of Neoadjuvant Therapy for Locally Advanced Colon Cancer With MSI-H /dMMR

The main pathological response rate of neoadjuvant therapy

The First Affiliated Hospital of Xiamen University

Antibodies

Immunomodulating Agents

Immunoglobulins

A total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the surgery.

A total of 60 patients will receive 4 cycles of CAPOX chemotherapy ,then receive the surgery.

Serplulimab

short-term radiotherapy

The study evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. In treatment group, a total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the surgery. In observerment group: a total of 60 patients will receive 4 cycles of CAPOX chemotherapy, then receive the surgery. The rate of pathologic complete response （pCR）, long-term prognosis and adverse effects will be analyzed.

This study is a prospective, randomized controlled, multicenter phase II study, with a design of superior efficacy，to compare the efficacy of neoadjuvant short-course radiotherapy combined with CapOX chemotherapy and PD-1 immunotherapy in locally advanced colon cancer. We will consecutively enrolled patients who were diagnosed with locally advanced colon cancer with T4 stage or bulky nodes. A total of 120 patients will be Randomized 1:1 to the treatment group and observerment group. In observerment group, patients will receive 4 cycles of CAPOX (Capecitabine: 1000mg/m2 d1-14 q3w; Oxaliplatin: 130mg/m2 d1 q3w)chemotherapy, then receive the surgery, followed by 4 cycles of CAPOX. In treatment group, patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOXand PD-1 antibody(Serplulimab,300mg d1 q3w), then receive the surgery,followed by 4 cycles of CAPOX.

Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)

Short-course Radiotherapy Combined With CAPOX and Pd-1 Inhibitor for Locally Advanced Colon Cancer: a Randomized, Prospective, Multicentre, Phase II Trial (TORCH-C)

pCR was defined as the absence, from surgical samples, of malignant cells in the primary site and regional lymph nodes

R0 resection refers to the complete removal of the tumor in the operation with microscopically negative margins

Rate of chemotherapy, radiotherapy and immunotherapy related severe adverse events

Rate of 3 years local recurrence free survival

Rate of surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.

Professor

Patients undergo open CME. A standard midline incision carefully protected is made through the abdominal wall and the abdominal cavity is explored. A colectomy with CME is performed with the removal of the afflicted colon and its accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia.

Patients undergo laparoscopic CME. A small infraumbilical incision is made through the abdominal skin and the abdominal cavity is insufflated with carbon dioxide to allow access and visualization. The abdominal cavity is explored. A colectomy with CME is performed using laparoscopic-assisted techniques. A 6-8cm midline auxiliary incision is made for specimen extraction and anastomosis.

A traditional midline incision is made through the abdominal wall and a colectomy with CME is performed.

Open surgery

3-5 small incisions are made through the abdominal wall for the placement of trocars and the abdominal cavity is insufflated with carbon dioxide to allow access, visualization and operation. A 6-8cm auxiliary incision is made for specimen extraction and anastomosis. Conversion may occur due to technical difficulties or intraoperative complications, which is defined when completion of the dissection of the mesocolon is performed through a traditional open abdominal approach. Patients undergo conversion to laparotomy will be excluded from this study.

Laparoscopic surgery

Yueming Sun, PhD

Yueming Sun

Fumin Zhang, Professor

Randomized, multicenter, phase III trial to compare the short and long outcomes of laparoscopic CME with open CME in treating patients with locally advanced colon cancer.

Laparoscopic complete mesocolic excision (CME) in treating colon cancer has been reported to be feasible and safe and holds many advantages when compared with traditional open surgery, such as reducing preoperative blood loss, alleviating postoperative pain and reducing complications and length of hospital stay. Whether laparoscopic CME could achieve an equivalent oncological outcome, especially for locally advanced malignancy, is still being discussed.

The purpose of this study is to determine the short and long outcomes of open and laparoscopic CME for locally advanced colon cancer patients. The primary endpoint is the 5-year disease-free survival rate. Secondary endpoints include completeness of mesocolon, morbidity and mortality, local recurrence, overall survival, quality of life et al.

In this study, eligible patient will be randomly allocated to receive either open or laparoscopic CME surgery. Randomization will be performed centrally and be stratified for age, gender, T-stage, tumor location. Patients will be randomized in a 2:1 ratio, in favor of the laparoscopic CME.

The extent of resection according to CME principle is identical for both arms. CME involves the removal of the afflicted colon and its accessory lymphvascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Type of anastomosis, location of auxiliary incision and drainage of surgical field are up to the discretion of the surgeon. In laparoscopic surgery, a "medial-to-lateral" approach and a no-touch isolation are required .

Intraoperative pictures were taken at various stages, as were photographs of the postoperative specimen, which will be assessed by a third-party expert to qualify the surgery.

The baseline demographics and conditions as well as the perioperative and postoperative outcomes will be recorded through a prior designed format.

Our study is expected to last seven years, of which two years for recruiting patients, five years for follow-up. Patients are followed up every 3 months for 2 year, every 6 months for 3 years postoperatively.

Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer

A Multicenter, Prospective, Randomized Clinical Trial to Investigate Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer

Length of postoperative hospital stay is defined as a duration between surgery and first discharge. An expected average is 10 days.

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.

A central review by pathologists to define the completeness of the mesocolon to be good, moderate or poor will be performed on the specimen photographs.

Compare the differences in postoperative quality of life of patients treated with these two regimens using EORTC QLQ-C30 questionnaire

West China Hospital

Changhai Hospital

Chinese PLA General Hospital

Peking Union Medical College Hospital

Ruijin Hospital

RenJi Hospital

Shanghai Changzheng Hospital

Wuhan Union Hospital, China

Fujian Medical University

First Affiliated Hospital of Chongqing Medical University

The First Affiliated Hospital with Nanjing Medical University

Director of the Colorectal Surgery Department

Patients receive 6 months of chemotherapy after surgery.

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

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.

Postoperative 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.

Neoadjuvant chemotherapy

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.

Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer	NCT03125980	Locally Advance...	capecitabine pl... capecitabine pl...	18 Years - 75 Years	Fudan University
Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer	NCT01918527	Colon Cancer	Capecitabine Oxaliplatin	18 Years -	Vejle Hospital
Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer	NCT01918527	Colon Cancer	Capecitabine Oxaliplatin	18 Years -	Vejle Hospital
Triplezumab Combined With CAPEOX Regimen in Neoadjuvant Therapy for Locally Advanced Colon Cancer	NCT04389151	Locally Advance...	Toripalimab	18 Years -	The First Affiliated Hospital of Xiamen University
Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)	NCT05732493	Locally Advance...	Serplulimab short-term radi... Oxaliplatin Capecitabine	18 Years -	Fudan University
Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer	NCT02682589	Colon Cancer	Open surgery Laparoscopic su...	18 Years -	The First Affiliated Hospital with Nanjing Medical University
Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer	NCT02682589	Colon Cancer	Open surgery Laparoscopic su...	18 Years -	The First Affiliated Hospital with Nanjing Medical University
Neoadjuvant Chemotherapy for the Treatment of Resectable Locally Advanced Colon Cancer	NCT02882269	Colon Cancer	Postoperative c... Neoadjuvant che...	18 Years - 80 Years	The First Affiliated Hospital with Nanjing Medical University

Spots Global Cancer Trial Database for locally advanced colon cancer