Almost-cCR, Surgery, Rectal Cancer
Conditions
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.
Interventions
PROCEDUREtransanal surgery
Transanal surgery could Preserve anus to reduce trauma and improve the quality of life
PROCEDUREMiles surgery
Miles surgery cut off the anus, enlarge the trauma and reduce the quality of life.
After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.
Sponsors
Zhang Rui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | three years | The progression-free survival of 3 years |
| OS | three years | 3 years of overall survival time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Wexner incontinence score | every 3 months,for 2 years | Describe the degree of Anus incontinence |
| Female sexual function index | every 3 months,for 2 years | Describe the function of sexual for female patients |
| QOL | every 3 months,for 2 years | Describe the quality of life for tumor patients |
| International prostate symptom score | every 3 months ,for 2 years | Describe the function of prostate,only for male patients |
| carcinoembryonic antigen（CEA） | every 3 months,for 2 years | The level of carcinoembryonic antigen in blood |
Countries
China
Contacts
Primary Contactrui zhang, doctor
Backup Contactxin liu, master
Outcome results
None listed