Clinical trial NCT05709249: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colon Cancer
Keywords: colon cancer
Traditional Chinese medicine
Lead sponsor: Jiangsu Famous Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2023-02-02
Enrollment: 730
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. Within 3 months after the completion of adjuvant chemotherapy.
4. 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).
5. Aged 20-80 years, men or women.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
7. With no radiographic evidence of tumor recurrence.
8. Sign the informed consent form.

Exclusion Criteria:

1. Presence of other malignancies in the past 5 years except curatively treated basal cell carcinoma or cervical carcinoma in situ.
2. Besides adjuvant chemotherapy, other adjuvant therapy such as radiotherapy, targeted therapy and immunotherapy has been used to treat colon cancer.
3. Antitumor Chinese patent medicine and decoction have been used for more than 3 months after surgery or within 1 month before enrollment.
4. Patients with severe comorbidities such as cardiovascular, cerebrovascular, renal, hepatic, hematopoietic system and other severe primary diseases.
5. Allergic to the ingredients of XLJDOD.
6. 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.).
7. Suspected or confirmed history of alcohol and drug abuse.
8. Patients with other conditions considered by the investigator should not participate in the study.
9. Patients who have recently participated in or are currently participating in other clinical trials of drugs.

Primary outcomes:
measure: Two-year disease-free survival (DFS)
timeFrame: Assess once 24 months after randomization
Secondary outcomes:
measure: Three-year disease-free survival (DFS)
timeFrame: Assess once 36 months after randomization
measure: One, two, three-year relapse rate (RR)
timeFrame: Assess at month 12, 24, 36 after randomization
measure: Three-year survival rate
timeFrame: Assess once 36 months after randomization
measure: Overall survival (OS)
timeFrame: Observation to the end of the study，assessed up to 24 months
measure: Changes in total score on the EORTCQLQ-C30 Scale
timeFrame: Measurement will be performed at baseline and month 6, 12 ,18 ,24, 36.
measure: Changes in total score on the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM)
timeFrame: Compared with the baseline period, the changes in MDASI-TCM score at month 6, 12 ,18 ,24, 36 will be measured.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Traditional Chinese Medicine
Study officials:
References: