Xian-Lian-Jie-Du Optimization Decoction as an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer

Study Overview
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Brief Summary
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This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Subjects in the intervention group will be treated with XLJDOD compound granule. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).

Detailed Description
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Subjects in the intervention group will be treated with XLJDOD compound granule. Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent). The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.

Official Title
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Efficacy of Xian-Lian-Jie-Du Optimization Decoction as an Adjuvant Treatment for Prevention of Recurrence of Stage IIIB/IIIC Colon Cancer：a Study Protocol for a Randomized Controlled Trial

Conditions
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Colon Cancer

Intervention / Treatment
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* Drug: XLJDOD compound granule
* Drug: placebo (XLJDOD mimetic agent)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colon carcinoma confirmed by pathology. Completion of surgical resection of tumors with negative margins (R0 resection) and at least 3 months of adjuvant chemotherapy based on 5-fluorouracil (5-FU). * *4 cycles of CAPOX (capecitabine and oxaliplatin), 6 cycles of FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or 4 cycles of single agent-5-FU, etc. Within 3 months after the completion of adjuvant chemotherapy. Patients with Stage IIIB or IIIC disease.* *IIIB: T3-T4aN1/N1cM0, T2-T3N2aM0 and T1-T2N2bM0, IIIC: T4aN2aM0, T3-T4aN2bM0 and T4bN1-N2M0, as defined by the American Joint Committee on Cancer (AJCC) 8th edition). Aged 20-80 years, men or women. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. With no radiographic evidence of tumor recurrence. Sign the informed consent form. Exclusion Criteria: Presence of other malignancies in the past 5 years except curatively treated basal cell carcinoma or cervical carcinoma in situ. Besides adjuvant chemotherapy, other adjuvant therapy such as radiotherapy, targeted therapy and immunotherapy has been used to treat colon cancer. Antitumor Chinese patent medicine and decoction have been used for more than 3 months after surgery or within 1 month before enrollment. Patients with severe comorbidities such as cardiovascular, cerebrovascular, renal, hepatic, hematopoietic system and other severe primary diseases. Allergic to the ingredients of XLJDOD. Any condition that is unstable or can jeopardize the safety of the patients and their compliance to the study, including pregnancy, plan to be pregnant, lactation and psychiatric disorders (schizophrenia, depression, and obsessive-compulsive disorder, etc.). Suspected or confirmed history of alcohol and drug abuse. Patients with other conditions considered by the investigator should not participate in the study. Patients who have recently participated in or are currently participating in other clinical trials of drugs.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention group<br>Subjects in the intervention group will be treated with XLJDOD compound granule. | Drug: XLJDOD compound granule<br>* Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses.<br>|
| Placebo Comparator: control group<br>Subjects in the control group will be treated with placebo (XLJDOD mimetic agent). | Drug: placebo (XLJDOD mimetic agent)<br>* The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two-year disease-free survival (DFS) | 2-year DFS is defined as the percentage of patients alive without disease recurrence at 2 years measured from the randomization date. | Assess once 24 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One, two-year relapse rate (RR) | RR is defined as the fraction of followed patients who have disease recurrence. All disease recurrences and deaths from colon cancer are events. Second primary same cancers and other primary cancers will be ignored. | Assess once 24 months after randomization | 
| Overall survival (OS) | OS is measured from the date of enrollment to the date of death, irrespective of cause. | Observation to the end of the study，assessed up to 24 months | 
| Changes in total score on the EORTCQLQ-C30 Scale | The changes of The European O-rganization for Reasearch and Treatment of Cancer score will be compared in the two groups prior to and following XLJDOD compound granule administration. It is a universal scale for all patients with malignant tumors with a total score of 126, ranging from 30 (least severe) to 126 (most severe). | Measurement will be performed at baseline and month 6, 12 ,18 ,24. | 
| Changes in total score on the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM) | The scale is divided into two parts. The first part mainly assesses the severity of 20 common clinical symptoms and TCM-related symptoms of patients with cancer in the past 24 hours. The second part is the evaluation scale of the interference of the above symptoms with daily functioning. It has a total of 26 items, each with a score of 0-10, leading to a total score of 0-260. | Compared with the baseline period, the changes in MDASI-TCM score at month 6, 12 ,18 ,24 will be measured. |