Clinical trial NCT03748485: Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis
Official title: Comparing the Treatment Efficacy in Clinical Local Advanced Colorectal Cancer (cTxN1/2M0) Following Preoperational Adjuvant Therapies and Pathologically Proved StageⅡ(pT0-3N0M0)With or Without Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Adjuvant Chemotherapy
Keywords: local advanced colorectal cancer
adjuvant chemotherapy
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 650
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: Adjuvant chemotherapy was unnecessary in pathological stage Ⅱ colorectal cancer following initial treatment of surgery without high risk factors of recurrences. The treatment efficacy of adjuvant chemotherapy for pT1-3N0M0 colorectal cancer following preoperational chemotherapy or chemoradiotherapy remains unclear. Part of clinical local advanced colorectal cancer(cTxN1-2M0), which turn out to be pT0-3N0M0 after preoperational chemotherapy or chemoradiotherapy, might not really need adjuvant chemotherapy due to the down-stage efficacy of the preoperational treatments, or the misleading by lymph nodes false-positive imaging diagnosis.

Detailed description: Colorectal cancer(CRC) nowadays rank the 3rd incidence and the 4th mortality in all cancers worldwide(ref). Although the coloscopy or liquid biopsy screen has improved the early diagnosis of CRC, about 26.5-36.0% of the patients were diagnosed local advanced CRC at the first visit. Part of clinical local advanced colorectal cancer(cTxN1-2M0), which turn out to be pT1-3N0M0 after preoperational chemotherapy or chemoradiotherapy, might not really need adjuvant chemotherapy due to the down-stage efficacy of the preoperational treatments, or the misleading by lymph nodes false-positive imaging diagnosis. Adjuvant chemotherapy was been admitted unnecessary in the pathological stage ⅡA (pT0-3N0M0) CRC following initial treatment of surgery without high risk factors of recurrences. The treatment efficacy of adjuvant chemotherapy for pT1-3N0M0 CRC following preoperational chemotherapy or chemoradiotherapy remains unclear. The aim of this study is to evaluate the efficacy/safety of adjuvant chemotherapy in clinical local advanced CRC (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved pT0-3N0M0 CRC. Patients are randomized to control group(down-staged pT0-3N0M0 CRC with 6 to 8 periods adjuvant chemotherapy) and experimental group(watch group, down-staged pT0-3N0M0 CRC without adjuvant chemotherapy). The primary endpoint is the 3-years disease-free survival after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular overall survival and side effect of chemotherapy.

Eligibility criteria: Inclusion Criteria:

* preoperative clinical tumor stage III （TxN1-2M0）CRC
* pathological proved CRC adenocarcinoma by endoscopic biopsy
* Post operational pathological T0-3N0M0 without high risk factors of recurrence
* Patient able to understand and sign written informed consent

Exclusion Criteria:

* Other malignant tumors history.
* Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses).
* Colorectal tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
* Non resectable lymph node metastasis.
* American Society of Anesthesiologists (ASA) grading≥ IV and/or, Eastern Cooperative Oncology Group(ECOG) score≥ 2.
* Physical or psychological dependence.
* Pregnant or breast feeding women.
* Not controlled pre-operational infection.
* Enrolled in other clinical trials within 4 weeks.
* Other clinical or laboratorial condition not recommended by investigators.

Primary outcomes:
measure: disease free survival
timeFrame: 3years
Secondary outcomes:
measure: overall survival
timeFrame: 5years
measure: adverse reaction of adjuvant therapies
timeFrame: 3years
measure: remission rate of adjuvant therapies
timeFrame: 1year
measure: death rate within 30 days post surgery
timeFrame: 30days
measure: complication in 30 days post surgery
timeFrame: 30days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: sixth affiliate hospital of Sun yatsen Hospital
name: Jianping Wang, MD/PHD
role: STUDY_CHAIR
References: