NCT05709249RecruitingPhase 3
Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer
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
Source: ClinicalTrials.gov · Last updated 30 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 730 (estimated)
- First submitted
- 17 Jan 2023
- Start date
- 1 Dec 2022
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Diseases
- Colorectal cancer
- NCT number
- NCT05709249
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 730
- From 1 Dec 2022 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antitumor Chinese patent medicine and decoction have been used for more than 3 months after surgery or within 1 month before enrollment.
- Patients who have recently participated in or are currently participating in other clinical trials of drugs.
Other illness
- 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.
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jiangsu Province Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.