Colon Neoplasm Clinical Trial
Official title:
Effect Analysis of Neoadjuvant Chemoradiotherapy Combined With Radical Surgery ( CME + D3 ) for Advanced Colon Cancer : Prospective, a Single-arm, Single Central, Clinical Trial Research
Verified date | November 2022 |
Source | Tang-Du Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In this study, a randomized controlled trial was conducted on advanced colon cancer patients with preoperative tumor staging T1-4/N1-2/M0 or T4/N0/M0 to determine the effectiveness of preoperative short-term radiotherapy combined with chemotherapy and whether it can effectively reduce the postoperative local recurrence rate, so as to provide better treatment for colon cancer patients and improve the oncological treatment effect of colon cancer.
Status | Active, not recruiting |
Enrollment | 177 |
Est. completion date | May 31, 2025 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Diagnosis of colon neoplasm - 18 years to 70 years - Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2 - ECOGS score=2 - thoraco-abdomina CT showed no obvious metastasis(The CT of liver and lung show uncertainty tubercle,suggestive performed PET-CT) cT4,cN0-2,M0 radiography Inclusion Criteria(according postoperative enhanced CT or MRI) - progress tubercle penetrate peritoneotome base - progress tubercle penetrate serous surface of neighboring organ - progress tubercle development by late mesentery or side abdominis Exclusion Criteria: - Appeared other system cancer - Patient with postoperative recurrent of colon cancer - Patient with malignancies history in recent 5 years - Pregnant or female of suckle period - The patient have adjuvant radiotherapy record in other system cancer before this time treatment,and Patient with surgical contraindications. - The patient have accepted adjuvant chemoradiotherapy before this time treatment. - Distant metastasis found during surgery - Patients with poor radiotherapy compliance and difficulty in coordination - Patients with mental disorders |
Country | Name | City | State |
---|---|---|---|
China | General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University | Xi'an | Shanxi |
Lead Sponsor | Collaborator |
---|---|
Tang-Du Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Investigate patients ORR | Investigate patients ORR(objective response rate ) include CR(complete response) and PR(partial response) | 7 days after surgery | |
Secondary | neoplasm down-staging status | Observation of neoplasm down-staging status in patients according to RECIST 1.1 | one month after surgery | |
Secondary | Investigate operation safety score | Operation safety reference Clavien degree of postoperative complication | one month after surgery | |
Secondary | local recurrent rate of neoplasm | Observation local recurrent rate of neoplasm in patients | 2 years after surgery | |
Secondary | Quality of life score | Investigate postoperative Quality of life in patients after surgery | one month after surgery | |
Secondary | Investigate patience pRR (pathologic response rate) | According to the English version of the Japanese Gastric Cancer Classification (JCGC) 3rd edition, pRR is defined as survival of tumor cells remaining in less than 2/3 of the tumor area (level Ib or higher) | 7 days after surgery | |
Secondary | R0 resection | R0 resection indicates a microscopically margin-negative resection,in which no gross or microscopic tumor remains in the primary tumor bed | immediately after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Terminated |
NCT04555135 -
A Clinical Study To Measure The Effect Of Use Of Artificial Intelligence (AI) Enabled Computer Aided Detection (CADe) Assistance Software In Detecting Colon Polyps During Standard Colonoscopy Procedures
|
N/A | |
Terminated |
NCT00249301 -
A Study of MLN8054 in Patients With Advanced Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT04369053 -
Prevention of Colorectal Cancer Through Multiomics Blood Testing
|
||
Recruiting |
NCT05345613 -
Tranexamic Acid During Colonic Endoscopic Resection Procedures
|
Phase 4 | |
Recruiting |
NCT05411783 -
Low Tie Versus High Tie of the Inferior Mesenteric Vein During Colorectal Cancer Surgery: A Randomized Clinical Trial
|
N/A | |
Recruiting |
NCT03803891 -
Endoscopic Full-Thickness Resection In Colon
|
||
Completed |
NCT04799080 -
Chemotherapy-induced Peripheral Neuropathy (CIPN) on Motor and Sensory Function
|
||
Recruiting |
NCT04920149 -
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
|
Phase 2 | |
Recruiting |
NCT05034692 -
Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy
|
N/A | |
Not yet recruiting |
NCT00295035 -
Phase III Trial of Gemcitabine, Curcumin and Celebrex in Patients With Metastatic Colon Cancer
|
Phase 3 | |
Recruiting |
NCT03065257 -
Endoscopic Resection Multicenter Registry
|
N/A | |
Recruiting |
NCT03198338 -
Ultrasound Guided Transversus Abdominis Plane(TAP) Block in Intensive Care Unit
|
N/A | |
Completed |
NCT05497726 -
Fluorescent Sentinel Lymph Node Identification in Colon Carcinoma Using Intravenous Bevacizumab-800CW
|
N/A | |
Completed |
NCT03723720 -
Calculating of Correlations Between ADR, PDR, MAP
|
||
Completed |
NCT03730441 -
Correlation Between ADR of Screening and All Colonoscopies
|
||
Recruiting |
NCT05446558 -
Long-term Results in Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy
|
N/A | |
Recruiting |
NCT03458689 -
Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Patients Undergoing Left Hemicolectomy
|
N/A | |
Completed |
NCT03719573 -
Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer
|
N/A | |
Completed |
NCT01535326 -
Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy
|
N/A |