Xian-Lian-Jie-Du Optimization Decoction as an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: intervention group Subjects in the intervention group will be treated with XLJDOD compound granule. |
Drug: 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.
|
| Placebo Comparator: control group Subjects in the control group will be treated with placebo (XLJDOD mimetic agent). |
Drug: placebo (XLJDOD mimetic agent)
The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.
|
Outcome Measures
Primary Outcome Measures
- Two-year disease-free survival (DFS) [Assess once 24 months after randomization]
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) [Assess once 24 months after randomization]
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) [Observation to the end of the study，assessed up to 24 months]
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 [Measurement will be performed at baseline and month 6, 12 ,18 ,24.]
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) [Compared with the baseline period, the changes in MDASI-TCM score at month 6, 12 ,18 ,24 will be measured.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Colon carcinoma confirmed by pathology.
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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.
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Within 3 months after the completion of adjuvant chemotherapy.
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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).
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Aged 20-80 years, men or women.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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With no radiographic evidence of tumor recurrence.
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Sign the informed consent form.
Exclusion Criteria:
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Presence of other malignancies in the past 5 years except curatively treated basal cell carcinoma or cervical carcinoma in situ.
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Besides adjuvant chemotherapy, other adjuvant therapy such as radiotherapy, targeted therapy and immunotherapy has been used to treat colon cancer.
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Antitumor Chinese patent medicine and decoction have been used for more than 3 months after surgery or within 1 month before enrollment.
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Patients with severe comorbidities such as cardiovascular, cerebrovascular, renal, hepatic, hematopoietic system and other severe primary diseases.
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Allergic to the ingredients of XLJDOD.
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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.).
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Suspected or confirmed history of alcohol and drug abuse.
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Patients with other conditions considered by the investigator should not participate in the study.
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Patients who have recently participated in or are currently participating in other clinical trials of drugs.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jiangsu Province Hospital of Traditional Chinese Medicine | Nanjing | China |
Sponsors and Collaborators
- Jiangsu Famous Medical Technology Co., Ltd.
- Jiangsu Province Hospital of Traditional Chinese Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022NL-203-02