Clinical trial NCT03431428: Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Almost-cCR
Surgery
Rectal Cancer
Lead sponsor: Liaoning Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PFS
timeFrame: three years
measure: OS
timeFrame: three years
Secondary outcomes:
measure: carcinoembryonic antigen（CEA）
timeFrame: every 3 months,for 2 years
measure: carbohydrate antigen 19-9（CA-199）
timeFrame: every 3 months,for 2 years
measure: International Index of Erectile Function-15
timeFrame: every 3 months ,for 2 years
measure: International prostate symptom score
timeFrame: every 3 months ,for 2 years
measure: Female sexual function index
timeFrame: every 3 months,for 2 years
measure: Wexner incontinence score
timeFrame: every 3 months,for 2 years
measure: QOL
timeFrame: every 3 months,for 2 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Liaoning cancer Hospital
state: Liaoning
Study officials:
affiliation: Sun Yat-sen University
name: peirong ding, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: ji zhu, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of China Medical University
name: zhenning wang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengjing Hospital
name: hong zhang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: yu han, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Jilin Provincial Tumor Hospital
name: zhaocheng chi, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: quan wang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Dalian Medical University
name: ge liu, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First People's Hospital of Jingzhou
name: hang lu, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: zheng liu, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Liaoning Cancer Hospital & Institute
name: rui Zhang, doctor
role: STUDY_DIRECTOR
References: