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Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer

Recruiting
Conditions
Rectal Neoplasms
Registration Number
NCT05871762
Lead Sponsor
Peking Union Medical College Hospital
Brief Summary

The purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in China, and to conduct cost utility analysis (CUA) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual need of medical units in each region and at each level. The investigators hope to provide evidence-based medical suggestions for medical quality control of rectal cancer and revision of clinical guidelines, and provides a source of decision making for medical management and medical insurance.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
3705
Inclusion Criteria
  • pathologically confirmed rectal adenocarcinoma
  • located within 12cm below the anal verge
Exclusion Criteria
  • diagnosed with distant metastasis
  • multiple primary colorectal cancers
  • history of previous malignant tumors
  • Pregnant or lactating women

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
3-year OS3 years

3-year overall survival

Secondary Outcome Measures
NameTimeMethod
3-year DFS3 years

3-year disease-free survival

3-year LR3 years

3-year local recurrence rate

adjuvant therapy rateat the time point of 3-year follow up

the percentage of patients who underwent standard adjuvant therapy

EUS/MRI assessment rateat the time point of surgery of the primary lesion

the percentage of patients who underwent standard rectal EUS/MRI assessment

3-year distant metastasis rate3 years

3-year distant metastasis rate

neoadjuvant therapy rateat the time point of surgery of the primary lesion

the percentage of patients who underwent standard neoadjuvant therapy

R0 resection rateat the time point of surgery of the primary lesion

the percentage of patients who underwent R0 resection

CCRimmediately after the completion of neoadjuvant therapy assessment

Clinical Complete Response

pCRimmediately after the completion of surgery

Pathologic Complete Response

30-day mortality30 days after the surgery

death occurring within 30 days of the surgery

Trial Locations

Locations (1)

Peking Union Medical College Hospital

🇨🇳

Beijing, Beijing, China

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