Non Small Cell Lung Cancer Clinical Trial
Official title:
Dynamic Observational Strategy for Stage IB-IIIA Non-Small Cell Lung Cancer Patients After Complete Resection Based on Longitudinal Undetectable Molecular Residual Disease: Prospective, Multicenter, Single-Arm Study
NCT number | NCT05457049 |
Other study ID # | CTONG 2201 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2022 |
Est. completion date | August 1, 2025 |
Molecular residual disease (MRD) has strong relationship with clinical outcome in multiple solid tumors. Here, the investigators try to verify the negative predictive value of undetectable MRD, which is considered as a superior prognostic factor for resected NSCLC patients, and not requiring excessive adjuvant therapy. Stage IB-IIIA resected NSCLC patients with landmark and longitudinal undetectable MRD are enrolled and under close surveillance in this study.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | August 1, 2025 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Stage IB-IIIA non-small cell cancer patients who after complete resection. - =18 years. - Two-round MRD tests confirm landmark undetectable MRD. - Expected survival =12 weeks. - Expected survival =12 weeks. - ECOG PS 1-2. - Willing to accept MRD monitoring every 3 months for a total of 2 years after operation. Exclusion Criteria: - Patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy. - Patients with a history of other malignancies in the past 5 years. - Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.). |
Country | Name | City | State |
---|---|---|---|
China | Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong Association of Clinical Trials |
China,
Zhang JT, Liu SY, Gao W, Liu SM, Yan HH, Ji L, Chen Y, Gong Y, Lu HL, Lin JT, Yin K, Jiang BY, Nie Q, Liao RQ, Dong S, Guan Y, Dai P, Zhang XC, Yang JJ, Tu HY, Xia X, Yi X, Zhou Q, Zhong WZ, Yang XN, Wu YL. Longitudinal Undetectable Molecular Residual Disease Defines Potentially Cured Population in Localized Non-Small Cell Lung Cancer. Cancer Discov. 2022 Jul 6;12(7):1690-1701. doi: 10.1158/2159-8290.CD-21-1486. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Two-years disease free survival rates for patients with longitudinal undetectable MRD | The 2-year DFS rate of patients who maintain 2-years undetectable MRD. | 2 year | |
Secondary | Two-years disease free survival rates for patients with six months longitudinal undetectable MRD | The 2-year DFS rate of patients who maintain 6-months undetectable MRD. | 2 year | |
Secondary | Two-years disease free survival rates for patients with 12-months longitudinal undetectable MRD | The 2-year DFS rate of patients who maintain 12-months undetectable MRD. | 2 year | |
Secondary | Two-years disease free survival rates for patients with 18-months longitudinal undetectable MRD | The 2-year DFS rate of patients who maintain 18-months undetectable MRD. | 2 year | |
Secondary | Two-years event-free survival rates for enrolled patients in two years | The events are defined as disease recurrence or detectable MRD. | 2 year |
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