Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almost-cCRs) were entered into two groups randomly. The estimated sample size of the minimal operation group was 221, and 221 in the Mile's group. Three years' progression-free survival(PFS) and overall survival(OS) were compared.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhang Rui

Criteria

Inclusion Criteria:

1. Histology is confirmed as rectal adenocarcinoma.

2. 18 to 75 years old.

3. Preoperative staging is lower than clinical stage primary tumor grade 3, regional lymph node grade 1, and metastasis was grade 0（cT3cN1M0）.

4. The anus couldn't be retained after TME.

5. Almost-cCR or cCR recurrence during observation.

Exclusion Criteria:

1. Patients were unable to tolerate the operation.

2. Preoperative stage: T4b or progress during the treatment.

3. HIV infection stage or chronic hepatitis B.

4. Active clinical severe infections.

5. Evil liquid state or decompensation of organ function.

6. Other malignant tumor history in five years.

7. Other primary carcinoma.

8. Unstable condition and incompliance of the patient