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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат placebo (XLJDOD mimetic agent)
  The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.

Первичные конечные точки

• Two-year disease-free survival (DFS) [Срок оценки: Assess once 24 months after randomization]

Вторичные конечные точки (6)

• Three-year disease-free survival (DFS) [Срок оценки: Assess once 36 months after randomization]
• One, two, three-year relapse rate (RR) [Срок оценки: Assess at month 12, 24, 36 after randomization]
• Three-year survival rate [Срок оценки: Assess once 36 months after randomization]
• Overall survival (OS) [Срок оценки: Observation to the end of the study，assessed up to 24 months]
• Changes in total score on the EORTCQLQ-C30 Scale [Срок оценки: 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) [Срок оценки: Compared with the baseline period, the changes in MDASI-TCM score at month 6, 12 ,18 ,24, 36 will be measured.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Jiangsu Province Hospital of Traditional Chinese Medicine — Нанкин

Публикации

• 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( PMID 37461034

Идентификаторы

NCT: NCT05709249 · 2022NL-203-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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