Status:
NOT_YET_RECRUITING
Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy
Lead Sponsor:
Tang-Du Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
(1) To evaluate the oncological effects of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode on TRG, Anal sphincter preservation surg...
Eligibility Criteria
Inclusion
- Aged between 18 and 70;
- Histologically confirmed adenocarcinoma of rectum;
- The distance from the lower edge of the tumor to the anus is ≤ 10cm;
- ECOG score ≤ 1;
- Have not received any anti-tumor treatment before;
- Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2; M0 chest and abdomen CT showed no obvious metastasis. (Note: PET-CT is recommended when small nodules can not be identified by liver or lung CT, and can still be included in the group when considering the possibility of metastasis)
- Hematological indicators and liver and kidney function within 7 days are within the normal range;
- Sign the informed consent form and be able to follow the research and /or follow-up procedures.
Exclusion
- Have serious basic diseases, such as heart disease, renal failure, severe liver failure or liver failure, coagulation dysfunction, etc; Postoperative recurrence of colorectal cancer;
- The patient had a history of malignant tumor within 5 years;
- Pregnant or lactating women;
- The patient has a history of adjuvant radiotherapy for other system diseases, and surgical contraindications, so it is not suitable for surgery;
- The patient has had radiotherapy and chemotherapy records before this visit;
- Distant metastasis was found during operation;
- Patients with poor radiotherapy compliance and difficult cooperation;
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 10 2027
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT06035133
Start Date
November 10 2023
End Date
November 10 2027
Last Update
September 13 2023
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