Clinical trial NCT03712969: Shenlingcao Oral Liquid for Patients With Stage II or IIIA NSCLC
Official title: Shenlingcao Oral Liquid for Patients With Stage II or IIIA Non-small Cell Lung Cancer Receiving Radical Resection: A Pragmatic, Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carcinoma, Non-Small-Cell Lung
Chemotherapy, Adjuvant
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, a pragmatic, open labelled, multi-center randomized controlled trial will be conducted. The study population are stage II and IIIA NSCLC patients undergoing R0 resection and will be scheduled for adjuvant chemotherapy. Potentially eligible patients will be screened by the research clinicians and requested to complete and sign a consent form before enrolment. Eligible patients who consent to participate will be randomly assigned to the intervention group (patients receive conventional treatment and Shenlingcao oral liquid) and the control group (patients only receive conventional treatment) designed dynamic stratified block randomized algorithm via a central randomization system for clinical research using 1:1 ratio.

The intervention and control group will be enrolled before the first chemoradiation. Non-allelic follow-up will be conducted in this study and terminated when the last enrolled patient follow up to 24 months. Prospectively collected information from patients, including baseline, chemoradiation, use of Shenlingcao Oral Liquid and the other complementary drugs, and various outcome measures (the questionnaire of EORTC QLQ, death, tumor recurrence, tumor metastasis, and chemotherapy-induced side effects of the blood system, etc.). Follow-up points included: Baseline (before giving chemotherapy), 2-3 days after each chemotherapy cycle, and 6,12,18,24,30,36 months after enrollment.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older;
* Pathological diagnosis of patients with stage II, III A primary NSCLC;
* R0 resection has been accepted;
* Received adjuvant chemotherapy or adjuvant chemotherapy for the first time after surgery;
* Informed consent has been signed.

Exclusion Criteria:

* Incorporation of other malignant tumors (such as leukemia, liver cancer, etc.);
* Patients with unclear pathological types;
* Patients with unclear pathological staging;
* Preserved Shenlingcao Oral Liquid before R0 resection surgery;
* Received immunotherapy or targeted therapy before R0 resection surgery;
* Radiotherapy and chemotherapy before R0 resection surgery.

Primary outcomes:
measure: The quality of life assessed by Research and Treatment of Cancer Quality of Life Questionnaire
timeFrame: 2-3 days after the fourth chemotherapy cycle
Secondary outcomes:
measure: The completion rate of chemotherapy
timeFrame: 2-3 days after the fourth chemotherapy cycle
measure: Disease-free survival
timeFrame: 24 months after enrollment
measure: Remission of hematological toxicity caused by chemotherapeutic drugs
timeFrame: 2-3 days after the fourth chemotherapy cycle
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: The West China Hospital of Sichuan university
name: Xin Sun, PhD
role: STUDY_DIRECTOR
References: