Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma (CTCs detection)

Third Military Medical University

Status: Unknown

Conditions: Lung Adenocarcinoma, Stage I; Treatment; Diagnoses Diseases; Circulating Tumor Cells

Treatments: Drug: chemotherapy（pemetrexed+CISPLATIN）; Other: CanPatrolTM to detect CTCs; Procedure: lobectomy; Procedure: Lymphadenectomy; Procedure: segmentecomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02951897

TMMU-DP-2016-4-25

Details and patient eligibility

About

In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases, 83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical treatment, will have a relapse or progression.

Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far, CTCs-detection technologies can be divided into epithelial cell adhesion molecule (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung Adenocarcinoma cases.

The investigator aim to explore whether CTCs detection prior to surgery can be contributive to the early diagnosis, or may help to predict the prognosis and guide the treatment strategy of early stage lung Adenocarcinoma.

Enrollment: 120 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stage I lung adenocarcinoma

Exclusion criteria

• cases with any new adjuvant treatment prior to surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 6 patient groups, including a placebo group

IA-CTC-High-enhance

Active Comparator group

Description:

IA lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.

Treatment:

Other: CanPatrolTM to detect CTCs

Procedure: lobectomy

Drug: chemotherapy（pemetrexed+CISPLATIN）

Procedure: Lymphadenectomy

IA-CTC-High-controls

Placebo Comparator group

Description:

IA lung adenocarcinoma cases with high abundant CTCs prior to operation will only undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.

Treatment:

Other: CanPatrolTM to detect CTCs

Procedure: lobectomy

Procedure: Lymphadenectomy

IA-CTC-low-controls

Placebo Comparator group

Description:

IA lung adenocarcinoma cases with low abundant CTCs prior to operation will only undergo segmentectomy. Postoperative CTC monitoring will be conducted.

Treatment:

Other: CanPatrolTM to detect CTCs

Procedure: segmentecomy

IB-CTC-High-enhance

Active Comparator group

Description:

IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.

Treatment:

Other: CanPatrolTM to detect CTCs

Procedure: lobectomy

Drug: chemotherapy（pemetrexed+CISPLATIN）

Procedure: Lymphadenectomy

IB-CTC-High-controls

Placebo Comparator group

Description:

IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.

Treatment:

Other: CanPatrolTM to detect CTCs

Procedure: lobectomy

Procedure: Lymphadenectomy

IB-CTC-low-controls

Placebo Comparator group

Description:

IB lung adenocarcinoma cases with low abundant CTCs prior to operation will undergo lobectomy\&lymphadenectomy. Postoperative CTC monitoring will be conducted.

Treatment:

Other: CanPatrolTM to detect CTCs

Procedure: lobectomy

Procedure: Lymphadenectomy