Clinical trial · Interventional
Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients
Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients: A Case-matched Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Almost-cCR | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Miles surgery | Procedure | — | UNRESOLVED |
| Preoperative chemoradiotherapy | Drug | — | UNRESOLVED |
| transanal surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- transanal surgery
- description
- To ensure the complete cutting edge with no residual tumor, the tumor with corresponding mesorectal excision was removed by the distance edge of 1cm. The intestinal wall was sutured to ensure the integrity of the bowel.
- interventionNames
- Procedure: transanal surgery
- Drug: Preoperative chemoradiotherapy
- type
- PLACEBO_COMPARATOR
- label
- Miles surgery
- description
- According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed.
- interventionNames
- Procedure: Miles surgery
- Drug: Preoperative chemoradiotherapy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMotamedi MAK, Mak NT, Brown CJ, Raval MJ, Karimuddin AA, Giustini D, Phang PT. Local versus radical surgery for early rectal cancer with or without neoadjuvant or adjuvant therapy. Cochrane Database Syst Rev. 2023 Jun 13;6(6):CD002198. doi: 10.1002/14651858.CD002198.pub3. PMID 37310167