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

January 31, 2023 updated by: Jiangsu Famous Medical Technology Co., Ltd.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

730

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Nanjing, China
        • Recruiting
        • Jiangsu Province Hospital of Traditional Chinese Medicine
        • Contact:
          • Yujia Wang
          • Phone Number: 18120192802

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Colon carcinoma confirmed by pathology.

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Two-year disease-free survival (DFS)
Time Frame: 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.
Assess once 24 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One, two-year relapse rate (RR)
Time Frame: 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.
Assess once 24 months after randomization
Overall survival (OS)
Time Frame: 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.
Observation to the end of the study，assessed up to 24 months
Changes in total score on the EORTCQLQ-C30 Scale
Time Frame: 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).
Measurement will be performed at baseline and month 6, 12 ,18 ,24.
Changes in total score on the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM)
Time Frame: 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.
Compared with the baseline period, the changes in MDASI-TCM score at month 6, 12 ,18 ,24 will be measured.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Famous Medical Technology Co., Ltd.

Collaborators

Jiangsu Province Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ACTUAL)

February 2, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022NL-203-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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