Study Stopped
Difficulty in patient recruitment
Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III Non-small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
6
1 country
1
Brief Summary
This study including two parts，one part is a randomized clinical trial design，another part is a registration study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable nonsmall-cell-lung-cancer
Started Apr 2017
Shorter than P25 for not_applicable nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2017
CompletedFirst Submitted
Initial submission to the registry
May 31, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2017
CompletedMarch 9, 2020
March 1, 2020
7 months
May 31, 2017
March 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
disease-free survival
disease-free survival
2-year
Secondary Outcomes (7)
overall survivals
2-year
Quality of Life
2-year
KPS
2-year
ECOG-PS
2-year
CEA
2-year
- +2 more secondary outcomes
Study Arms (3)
Huaier Granule
EXPERIMENTALHuaier Granule
placebo
PLACEBO COMPARATORplacebo
No-treatment Control
NO INTERVENTIONpatients refused any treatment
Interventions
Eligibility Criteria
You may qualify if:
- Patients with complete resection who are at TNM (primary tumor, regional nodes, metastasis) stage II-Ⅲa, postoperative pathology confirmed for non-small cell lung cancer;
- Has completed four cycle standard solution of adjuvant chemotherapy, or refused to accept the postoperative adjuvant chemotherapy;
- Patients between 18 and 70 years old, no gender restriction;
- Eastern Cooperative Oncology Group (ECOG) PS of two or less;
- Before the start of the study, patient fully understands the study and is willing to sign the informed consent form;
You may not qualify if:
- Receiving adjuvant chemotherapy patients started greater than 24 weeks from surgical resection;
- Refused adjuvant chemotherapy patients started greater than 8 weeks from surgical resection;
- Suspected malignant pleural effusion;
- There is no clear pathological diagnosis;
- Combined with other cancer;
- Patient have a positive surgical margin;
- Accept other treatment for lung cancer of postoperative；
- Combined with severe idiopathic disease of liver, kidney and hematopoietic system;
- Combined psychosis or AIDS;
- Allergy to the test drug;
- Pregnant or lactating women;
- Participation in any other clinical trial within three months;
- Conditions that are considered not suitable for this study investigators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Du Ying Ying
Hefei, Anhui, 230022, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
guoping sun, doctor
The First Affiliated Hospital of Anhui Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2017
First Posted
June 23, 2017
Study Start
April 25, 2017
Primary Completion
November 23, 2017
Study Completion
November 23, 2017
Last Updated
March 9, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share