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Trial record 2 of 247989 for:    ALL

Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III Non-small Cell Lung Cancer (NSCLC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Qidong Gaitianli Medicines Co., Ltd
ClinicalTrials.gov Identifier:
NCT03198117
First received: May 31, 2017
Last updated: June 21, 2017
Last verified: May 2017
  Purpose
This study including two parts,one part is a randomized clinical trial design,another part is a registration study.

Condition Intervention
Non-small Cell Lung Cancer Drug: Huaier Granule Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III NSCLC After Postoperative Adjuvant Chemotherapy: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial, Along With a Registration Study

Resource links provided by NLM:


Further study details as provided by Qidong Gaitianli Medicines Co., Ltd:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 2-year ]
    disease-free survival


Secondary Outcome Measures:
  • overall survivals [ Time Frame: 2-year ]
    overall survivals

  • Quality of Life [ Time Frame: 2-year ]
    Quality of Life-EORTC QLQ-C30

  • KPS [ Time Frame: 2-year ]
    Karnofsky

  • ECOG-PS [ Time Frame: 2-year ]
    ECOG-PS

  • CEA [ Time Frame: 2-year ]
    tumor markers

  • CYFRA21-1 [ Time Frame: 2-year ]
    tumor markers

  • SCC [ Time Frame: 2-year ]
    tumor markers


Estimated Enrollment: 798
Actual Study Start Date: April 25, 2017
Estimated Study Completion Date: June 1, 2022
Estimated Primary Completion Date: June 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Huaier Granule
Huaier Granule
Drug: Huaier Granule
a Chinese traditional medicine
Placebo Comparator: placebo
placebo
Other: placebo
placebo
No Intervention: No-treatment Control
patients refused any treatment

Detailed Description:

This study include a multicenter, randomized, controlled, double-blind, placebo-controlled post-market clinical trial and a registration study.

The randomized clinical trial included subjects (n =798) will be randomly divided into experimental (n = 532) and control groups (n =266) according to a random number table. Patients in the experimental group will receive Huaier Granule (20g/time, 3 times/d). Patients in the control group will receive placebo (20g/time, 3 times/d). The registration study plan to recruitment at least 300 patients.

The primary outcome measures is disease-free survival,secondary outcome measures is 2-year overall survivals, ECOG-performance status, Karnofsky performance score and tumor markers (CEA、CYFRA21-1、SCC).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03198117

Locations
China, Anhui
Du Ying Ying
Hefei, Anhui, China, 230022
Sponsors and Collaborators
Qidong Gaitianli Medicines Co., Ltd
Investigators
Principal Investigator: guoping sun, doctor First Affiliated Hospital of Anhui Medical University
  More Information

Responsible Party: Qidong Gaitianli Medicines Co., Ltd
ClinicalTrials.gov Identifier: NCT03198117     History of Changes
Other Study ID Numbers: HE-201701
Study First Received: May 31, 2017
Last Updated: June 21, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Recurrence
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 23, 2017