Comparison of Lobectomy and Segmentectomy for cT1aN0M0 Peripheral NSCLC
NCT ID: NCT02481661
Last Updated: 2015-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
610 participants
INTERVENTIONAL
2015-07-31
2022-07-31
Brief Summary
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Detailed Description
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Outline: This is a multicenter, prospective, randomized open phase III study of anatomic segmentectomy vs lobectomy for the patients with peripheral stage IA (≤ 2cm) non-small cell lung cancer (NSCLC). According to completely random block design, the patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.
* Arm II: Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.
Patients will be followed up every 3 months for the first year and then every 6 months for the subsequent 2 years and annually for 5 years postoperatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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segmentectomy
Patients undergo anatomic segmentectomy by minimal incision thoracotomy or thoracoscopy/VATS.
segmentectomy
segmentectomy in Arm I and lobectomy in Arm II
lobectomy
Patients undergo lobectomy by minimal incision thoracotomy or thoracoscopy/VATS.
segmentectomy
segmentectomy in Arm I and lobectomy in Arm II
Interventions
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segmentectomy
segmentectomy in Arm I and lobectomy in Arm II
Eligibility Criteria
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Inclusion Criteria
2. Preoperative criteria:
ⅰ)Center of tumor is located in the outer third of the lung field, and the maximal diameter ≤ 2 cm(including coronal, traverse and sagittal view) confirmed by 1mm thin layer contrast-enhanced CT scan.
ⅱ)no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS.
3. Intraoperative criteria:
ⅰ)Adenocarcinama or squamous cell carcinoma of lung confirmed by frozen section.
ⅱ)Lobectomy, single segmentectomy or combined segmentectomy is feasible.
ⅲ)Confirmation of N0 status by frozen section examination of nodal levels 10 and 13 for segmentectomy, and 10 for lobectomy.
4. ECOG performance status 0-2.
5. No other malignancy within the past 3 years( except for well prognostic malignancy such as basal cell carcinoma of skin, superficial bladder cancer, or carcinoma in situ of the cervix).
6. No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
7. No prior chemotherapy or radiation therapy.
8. Lobectomy is tolerated.
9. Sufficient organ functions.
10. Written informed consent.
Exclusion Criteria
2. Simultaneous or metachronous (within the past 5 years) multiple cancers.
3. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy.
4. Psychosis.
5. Uncontrollable diabetes mellitus.
6. History of severe heart disease.
7. The maximal diameter of GGO≤5mm.
8. N1, N2, or M1a is confirmed postoperatively.
9. Postoperative adjuvant therapy (chemotherapy ,radiotherapy or targeted therapy).
10. Other types of lung cancer such as small cell lung cancer, large cell lung cancer, etc.
11. Confirmation of benign disease by postoperative pathologic examination.
12. Lesion located in the middle lobe.
18 Years
70 Years
ALL
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZhejiangCH
Identifier Type: -
Identifier Source: org_study_id
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