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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03431428
• Other study ID #: 20171112
• Status: Recruiting
• Phase: Phase 3
• First received: January 13, 2018
• Last updated: February 10, 2018
• Start date: January 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2017
• Source: Liaoning Tumor Hospital & Institute
• Contact: rui zhang, doctor
• Phone: 8613898872185
• Email: zzzrrr1234[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 477
• Est. completion date: December 31, 2022
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Almost-cCR
• Rectal Cancer
• Rectal Neoplasms
• Surgery

Intervention

Procedure:
• transanal surgery
Transanal surgery could Preserve anus to reduce trauma and improve the quality of life
• Miles surgery
Miles surgery cut off the anus, enlarge the trauma and reduce the quality of life.

Drug:
• Preoperative chemoradiotherapy
After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.

Locations

Country	Name	City	State
China	Liaoning cancer Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Zhang Rui

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	The progression-free survival of 3 years	three years
Primary	OS	3 years of overall survival time	three years
Secondary	carcinoembryonic antigen(CEA)	The level of carcinoembryonic antigen in blood	every 3 months,for 2 years
Secondary	carbohydrate antigen 19-9(CA-199)	The level of carbohydrate antigen 19-9 in blood	every 3 months,for 2 years
Secondary	International Index of Erectile Function-15	Describe the function of Erectile ,only for male patients	every 3 months ,for 2 years
Secondary	International prostate symptom score	Describe the function of prostate,only for male patients	every 3 months ,for 2 years
Secondary	Female sexual function index	Describe the function of sexual for female patients	every 3 months,for 2 years
Secondary	Wexner incontinence score	Describe the degree of Anus incontinence	every 3 months,for 2 years
Secondary	QOL	Describe the quality of life for tumor patients	every 3 months,for 2 years