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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Surgery; Almost-cCR
• Intervention / Treatment: Procedure: transanal surgery; Drug: Preoperative chemoradiotherapy; Procedure: Miles surgery

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 Type: Interventional
• Enrollment (Anticipated): 477
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: rui zhang, doctor; Phone Number: 8613898872185; Email: zzzrrr1234@sina.com
• Study Contact Backup: Name: xin liu, master; Phone Number: 8618900918981; Email: liuxin5626855@sina.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • Liaoning Cancer Hospital
      • Contact: Rui Zhang, doctor; Phone Number: 13898872185; Email: zzzrrr1234@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: transanal surgery; Transanal surgery could Preserve anus to reduce trauma and improve the quality of life; Drug: Preoperative chemoradiotherapy; After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.
Placebo Comparator: 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.	Drug: Preoperative chemoradiotherapy; After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.; Procedure: Miles surgery; Miles surgery cut off the anus, enlarge the trauma and reduce the quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	The progression-free survival of 3 years	three years
OS	3 years of overall survival time	three years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhang Rui
• Investigators: Principal Investigator: peirong ding, doctor, Sun Yat-sen University; Principal Investigator: ji zhu, doctor, Fudan University; Principal Investigator: zhenning wang, doctor, First Hospital of China Medical University; Principal Investigator: hong zhang, doctor, Shengjing Hospital; Principal Investigator: yu han, doctor, Harbin Medical University; Principal Investigator: zhaocheng chi, doctor, Jilin Provincial Tumor Hospital; Principal Investigator: quan wang, doctor, The First Hospital of Jilin University; Principal Investigator: ge liu, doctor, The First Affiliated Hospital of Dalian Medical University; Principal Investigator: hang lu, doctor, The First People's Hospital of Jingzhou; Principal Investigator: zheng liu, doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Study Director: rui Zhang, doctor, Liaoning Tumor Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 13, 2018
• First Submitted That Met QC Criteria: February 10, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 10, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 20171112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No