Clinical trial NCT05279612: Effect Analysis of Neoadjuvant Chemoradiotherapy Combined With Surgery in Laparoscope for Advanced Colon Cancer
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Neoplasm
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of colon neoplasm, 18 years to 70 years, Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2, 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）

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Investigate patients ORR
timeFrame: 7 days after surgery
Secondary outcomes:
measure: neoplasm down-staging status
timeFrame: one month after surgery
measure: Investigate operation safety score
timeFrame: one month after surgery
measure: local recurrent rate of neoplasm
timeFrame: 2 years after surgery
measure: Quality of life score
timeFrame: one month after surgery
measure: Investigate patience pRR (pathologic response rate)
timeFrame: 7 days after surgery
measure: R0 resection
timeFrame: immediately after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University
state: Shanxi
Study officials:
affiliation: General Surgery,Tang-Du of Military Medical University
name: Nan Wang, Doctor
role: STUDY_DIRECTOR
References: