NCT05871762
Recruiting
Not Applicable
Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer-a National Multi-center, Prospective, Real World Study
ConditionsRectal Neoplasms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Neoplasms
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 3705
- Locations
- 1
- Primary Endpoint
- 3-year OS
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
3-year OS
Time Frame: 3 years
3-year overall survival
Secondary Outcomes
- 3-year DFS(3 years)
- 3-year LR(3 years)
- adjuvant therapy rate(at the time point of 3-year follow up)
- EUS/MRI assessment rate(at the time point of surgery of the primary lesion)
- 3-year distant metastasis rate(3 years)
- neoadjuvant therapy rate(at the time point of surgery of the primary lesion)
- R0 resection rate(at the time point of surgery of the primary lesion)
- CCR(immediately after the completion of neoadjuvant therapy assessment)
- pCR(immediately after the completion of surgery)
- 30-day mortality(30 days after the surgery)
Study Sites (1)
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