Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis

Colorectal Cancer Clinical Trial

— CANWATCH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03748485
• Other study ID #: L2018ZSLYEC-162
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: December 30, 2027

Study information

• Verified date: February 2024
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Jianping Wang, MD/PHD
• Phone: +86 13808874808
• Email: wangjpgz[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adjuvant Chemotherapy
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• wait and watch
clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stage?(pT0-3N0M0),without(wait and watch) adjuvant chemotherapy

Drug:
• adjuvant chemotherapy
clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stage?(pT0-3N0M0),with adjuvant chemotherapy

Locations

Country	Name	City	State
China	Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival	3years disease-free survival rate	3years
Secondary	overall survival	5years overall survival rate	5years
Secondary	adverse reaction of adjuvant therapies	Rate of participants with myelosuppression, gastrointestinal reaction, infection, lose hair	3years
Secondary	remission rate of adjuvant therapies	CRC remission evaluation using RECIST after adjuvant therapies	1year
Secondary	death rate within 30 days post surgery	death related directly with operation within 30 days	30days
Secondary	complication in 30 days post surgery	Rate of participants with complications such as bleeding,infection,anastomotic fistula,etc	30days