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A prospective study on the key diagnosis and treatment techniques of local advanced rectal cancer invading sacrum

A prospective study on the key diagnosis and treatment techniques of local advanced rectal cancer invading sacrum

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034713
Enrollment
Unknown
Registered
2020-07-16
Start date
2020-08-03
Completion date
Unknown
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

experimental group:Transabdominal combined with posterior sacral approach for surgical treatment
control group:Non operative treatment

Sponsors

Peking University Shougang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patients were older than 18 and less than 75 years old; 2. The patients whose lower edge of tumor is less than 5cm away from anal margin and can be expected to be resected, but the anus can not be preserved; 3. Pathological diagnosis of rectal cancer; Patients with T4 tumor confirmed by preoperative MRI staging; 4. Patients voluntarily accept this study, sign informed consent, and can cooperate with clinical follow-up.

Exclusion criteria

Exclusion criteria: 1. Rectal cancer with acute complications (complete intestinal obstruction, perforation and massive hemorrhage); 2. Pregnant or lactating female patients; 3. Patients with definite distant metastasis (including isolated liver and lung metastases), extensive intraperitoneal metastasis or cancerous ascites; 4. Patients with contraindication of operation; 5. Patients with cognitive impairment or mental illness; 6. The patients with urogenital dysfunction before operation; 7. Severe hepatic and renal insufficiency was defined as: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times of the upper limit of normal value, and serum creatinine > the upper limit of normal value; 8. Patients with allergic constitution or known allergy to allogeneic protein; 9. Other situations in which the doctor could not participate in the trial as judged by the doctor; 10. ASA grade IV or V; 11. Severe emphysema, interstitial pneumonia or ischemic heart disease can not tolerate surgery.

Design outcomes

Primary

MeasureTime frame
location and size of tumor;tumor grades and stages;CEA;MMR;

Secondary

MeasureTime frame
MSI;RAS;BRAF;PIK3CA;SMAD4;ß-catenin;PTEN;

Countries

China

Contacts

Public ContactGu Jin

Peking University Shougang Hospital

zIgujin@126.com+86 13801180717

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026