Effect Analysis of Neoadjuvant Chemoradiotherapy Combined With Surgery in Laparoscope for Advanced Colon Cancer

• Sponsor: Tang-Du Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05279612
• Collaborator: (none)
• Enrollment: 177
• Location: 1
• Anticipated Duration (Months): 44
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Neoplasm	Radiation: Short-term neoadjuvant chemoradiotherapy

Detailed Description

This is prospective,a single-arm, single center, clinical trail study.The patient entered the study after meeting that criteria.The ORR, R0 resection, OS and DFS of patients and neoplasm down-staging status,etc would be compared.

Study Design

• Study Type: Observational
• Actual Enrollment: 177 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Oct 30, 2024
• Anticipated Study Completion Date: May 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
neoadjuvant chemoradiotherapy group preoperative 1 circle chemotherapy(CapeOX) combined with short-course radiotherapy ，Surgical treatment(CME+D3) after four weeks of 2 circle chemotherapy(CapeOX).	Radiation: Short-term neoadjuvant chemoradiotherapy; Short-term radiotherapy ( 25 Gy, 5f ) + XELOX regimen was performed before operation for two cycles. After the condition was evaluated by enhanced CT, whether the patients belonged to PD, SD, PR and CR was analyzed (reference RECIST 1.1). Surgery was performed four weeks after chemotherapy.
neadjuvant chemotherapy group preoperative 3 circle chemotherapy(CapeOX) combined with surgical treatment(CME+D3)

Outcome Measures

Primary Outcome Measures

1. Investigate patients ORR [7 days after surgery]

   Investigate patients ORR(objective response rate ) include CR(complete response) and PR(partial response)

Secondary Outcome Measures

1. neoplasm down-staging status [one month after surgery]

   Observation of neoplasm down-staging status in patients according to RECIST 1.1

2. Investigate operation safety score [one month after surgery]

   Operation safety reference Clavien degree of postoperative complication

3. local recurrent rate of neoplasm [2 years after surgery]

   Observation local recurrent rate of neoplasm in patients

4. Quality of life score [one month after surgery]

   Investigate postoperative Quality of life in patients after surgery

5. Investigate patience pRR (pathologic response rate) [7 days after surgery]

   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)

6. R0 resection [immediately after surgery]

   R0 resection indicates a microscopically margin-negative resection,in which no gross or microscopic tumor remains in the primary tumor bed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University	Xi'an	Shanxi	China

Sponsors and Collaborators

• Tang-Du Hospital

Investigators

• Study Director: Xianli He, Doctor, General Surgery,Tang-Du of Military Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tang-Du Hospital
• ClinicalTrials.gov Identifier: NCT05279612
• Other Study ID Numbers: K202012-12
• First Posted: Mar 15, 2022
• Last Update Posted: Apr 5, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

No Results Posted as of Apr 5, 2022