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

Phase 3

• Conditions: Almost-cCR; Surgery; Rectal Cancer
• Interventions: Procedure: transanal surgery; Procedure: Miles surgery; Drug: Preoperative chemoradiotherapy

• Registration Number: NCT03431428
• Lead Sponsor: Zhang Rui

Brief 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.

Detailed Description

Patients with low rectal cancer were treated with neoadjuvant radiotherapy, and two cycles of XELOX at the interval. All almost-cCRs after neoadjuvant treatment were randomly divided into minimal operation group or Mile's group. All cCRs were treated with "watch and wait". Patients after local recurrence were randomly divided into minimal operation group or Mile's group. If pathological result was pathological staging 3 after neoadjuvant therapy（ypT3） in minimal operation group or local postoperative recurrence occurred, patients need supplement of abdominoperineal resection (APR). With 3 years follow-up，the main research goals are 3 years of progression-free survival(PFS) and overall survival(OS). Secondary endpoints are side effects of chemotherapy, assessment of quality of life, surgical complications, adverse prognostic factors and so on.

Study Timeline

• Status Verified: 2017-12
• Study Start: 2018-01-01
• Study First Submitted: 2018-01-13
• Study First Submitted QC: 2018-02-10
• Last Update Submitted: 2018-02-10
• Study First Posted: 2018-02-13
• Last Update Posted: 2018-02-13
• Primary Completion: 2020-01-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 477

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transanal surgery	transanal surgery	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.
transanal surgery	Preoperative chemoradiotherapy	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.
Miles surgery	Miles surgery	According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed.
Miles surgery	Preoperative chemoradiotherapy	According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed.

Primary Outcome Measures

Name	Time	Method
PFS	three years	The progression-free survival of 3 years
OS	three years	3 years of overall survival time

Secondary Outcome Measures

Name	Time	Method
carcinoembryonic antigen（CEA）	every 3 months,for 2 years	The level of carcinoembryonic antigen in blood
carbohydrate antigen 19-9（CA-199）	every 3 months,for 2 years	The level of carbohydrate antigen 19-9 in blood
International Index of Erectile Function-15	every 3 months ,for 2 years	Describe the function of Erectile ,only for male patients
International prostate symptom score	every 3 months ,for 2 years	Describe the function of prostate,only for male patients
Female sexual function index	every 3 months,for 2 years	Describe the function of sexual for female patients
Wexner incontinence score	every 3 months,for 2 years	Describe the degree of Anus incontinence
QOL	every 3 months,for 2 years	Describe the quality of life for tumor patients

Trial Locations

Locations (1)

Liaoning cancer Hospital; 🇨🇳 Shenyang, Liaoning, China