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| Name | Class |
|---|---|
| Jiangsu Province Hospital of Traditional Chinese Medicine | OTHER |
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Active Comparator | Subjects in the intervention group will be treated with XLJDOD compound granule. |
|
| control group | Placebo Comparator | Subjects in the control group will be treated with placebo (XLJDOD mimetic agent). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XLJDOD compound granule | Drug | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Three-year disease-free survival (DFS) | 3-year DFS is defined as the percentage of patients alive without disease recurrence at 3 years measured from the randomization date. | Assess once 36 months after randomization |
| One, two, three-year relapse rate (RR) |
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Inclusion Criteria:
Colon carcinoma confirmed by pathology.*
*Preoperative endoscopy showed that the distal end of the tumor was ≥12cm from the anal margin. If the patient did not undergo endoscopic examination before surgery, the distance of the tumor from the anal margin was ≥12cm according to the results of intraoperative examination or preoperative imaging examination.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujia Wang | Contact | 18120192802 | 1217909635@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital of Traditional Chinese Medicine | Recruiting | Nanjing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37461034 | Derived | Geng X, Wang Z, Feng L, Gu Y, Wang R, Yao Q, Xu Y, Wu J, Jiang Z, Chen K, Hu W, Tang D, Huo J, Li L, Bu Q, Zhao S, Zhang B, Cheng H. Efficacy and safety of Xian-Lian-Jie-Du optimization decoction as an adjuvant treatment for prevention of recurrence in patients with stage IIIB/IIIC colon cancer: study protocol for a multicentre, randomized controlled trial. BMC Complement Med Ther. 2023 Jul 17;23(1):239. doi: 10.1186/s12906-023-04052-2. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| placebo (XLJDOD mimetic agent) | Drug | The course of placebo in control group will be in accordance with that of XLJDOD in intervention group. |
|
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 at month 12, 24, 36 after randomization |
| Three-year survival rate | 3-year survival rate is defined as the percentage of patients alive at 3 years measured from the randomization date. | Assess once 36 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, 36. |
| 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, 36 will be measured. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |