Back to resultsXian-Lian-Jie-Du Optimization Decoction as an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer
Primary Purpose
Colon Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
XLJDOD compound granule
placebo (XLJDOD mimetic agent)
Sponsored by
About this trial
This is an interventional prevention trial for Colon Cancer
Eligibility Criteria
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.
Sites / Locations
- Jiangsu Province Hospital of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
intervention group
control group
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Overall survival (OS)
OS is measured from the date of enrollment to the date of death, irrespective of cause.
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).
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.
Full Information
NCT ID
NCT05709249
First Posted
January 17, 2023
Last Updated
January 31, 2023
Sponsor
Jiangsu Famous Medical Technology Co., Ltd.
Collaborators
Jiangsu Province Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05709249
Brief Title
Xian-Lian-Jie-Du Optimization Decoction as an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Famous Medical Technology Co., Ltd.
Collaborators
Jiangsu Province Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
730 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
Subjects in the intervention group will be treated with XLJDOD compound granule.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).
Intervention Type
Drug
Intervention Name(s)
XLJDOD compound granule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo (XLJDOD mimetic agent)
Intervention Description
The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.
Primary Outcome Measure Information:
Title
Two-year disease-free survival (DFS)
Description
2-year DFS is defined as the percentage of patients alive without disease recurrence at 2 years measured from the randomization date.
Time Frame
Assess once 24 months after randomization
Secondary Outcome Measure Information:
Title
One, two-year relapse rate (RR)
Description
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.
Time Frame
Assess once 24 months after randomization
Title
Overall survival (OS)
Description
OS is measured from the date of enrollment to the date of death, irrespective of cause.
Time Frame
Observation to the end of the study，assessed up to 24 months
Title
Changes in total score on the EORTCQLQ-C30 Scale
Description
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).
Time Frame
Measurement will be performed at baseline and month 6, 12 ,18 ,24.
Title
Changes in total score on the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM)
Description
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.
Time Frame
Compared with the baseline period, the changes in MDASI-TCM score at month 6, 12 ,18 ,24 will be measured.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yujia Wang
Phone
18120192802
Email
1217909635@qq.com
Facility Information:
Facility Name
Jiangsu Province Hospital of Traditional Chinese Medicine
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yujia Wang
Phone
18120192802
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Xian-Lian-Jie-Du Optimization Decoction as an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer
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