Surgical Treatment of Elderly Patients With cT1N0M0 Non-small Cell Lung Cancer Comparison Between Sublobar Resection and Lobectomy

Non-small Cell Lung Cancer Clinical Trial

— STEPS  

Official title:

Surgical Treatment of Elderly Patients With Early Stage Non-small Cell Lung Cancer (STEPS): Comparison Between Sublobar Resection and Lobectomy - an Open, Multicenter, Randomized Phase III Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02360761
• Other study ID #: CTONG1504
• Status: Recruiting
• Phase: Phase 3
• First received: January 24, 2015
• Last updated: September 17, 2016
• Start date: January 2016
• Est. completion date: January 2022

Study information

• Verified date: September 2016
• Source: Peking University People's Hospital
• Contact: Jun Wang, M.M.
• Phone: +8601088326650
• Email: Jwangmd[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The role of sublobar resection(Wedge resection or anatomic segmentectomy) for small(≤ 2cm) early stage non-small cell lung cancer has been studied by Lung Cancer Study Group and is being studied by several ongoing trials. However, elderly patients(aged ≥70 years) in these trials is under-represented, as in most of the ongoing clinical trials. This study focuses on the elderly population of early stage lung cancer, and aims to investigate the outcome of lobectomy versus sublobar resection for peripheral stage I non-small cell lung cancer (NSCLC) in elderly patients.

Description:

This randomized trial is to the best of our knowledge the first one designed to compare sublobar resection and lobectomy for elderly patients, in order to address these open questions:In patients aged 70 years or older and with clinical stage T1N0M0 NSCLC, (1) whether sublobar resection can achieve similar disease-free survival compared to lobectomy, (2) whether sublobar resection can reduce the postoperative mortality and morbidity,(3) whether sublobar resection can reserve better pulmonary function and quality of life for elderly patients of NSCLC?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 339
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Aged 70 years or older

• Preoperative criteria (contrast-enhanced Computed tomography scan)

• Suspected non-small cell lung cancer

• Clinical stage ?A, i.e. T1N0M0 (tumor diameter =3 cm, surrounded by visceral pleura, short-axis of lymph node <1 cm or cold lymph nodes on PET scan)

• The maximum diameter of consolidation of the maximum tumor diameter (consolidation/tumor ratio, C/T ratio) is no less than 0.5 in sub-solid lesions

• Eligible for sublobar resection with sufficient margin

• Intraoperative criteria

• Histologically confirmed invasive NSCLC, i.e. NSCLC other than pre-invasive adenocarcinomas defined by The International Association for the Study of Lung Cancer (adenocarcinoma in situ, and minimally invasive adenocarcinoma)

• Pathological exclusion of suspected lymph nodes involvement

• Feasible to perform sublobar resection in terms of surgical margin requirement

• General criteria

• Must sign informed consent by the patient or his/her entrusted party

• Must complete 4-year mortality index and comprehensive geriatric assessment(CGA) if necessary

• The physiological reservation can tolerate lobectomy

Exclusion Criteria:

• Unable to comply with the study procedure

• Past thoracic surgery history, except for diagnostic thoracoscopy

• Malignant tumor history within the past 5 years, except for the following conditions:

cured skin basal cell carcinoma, superficial bladder carcinoma, and uterine cervix cancer in situ

• Any active systemic diseases including uncontrolled hypertension, unstable angina pectoris, newly onset of angina pectoris within recent 3 months, congestive heart failure (class II or plus of New York Heart Association, NYHA), myocardial infarction within recent 6 months, severe disease in the need of medication such as arrhythmia, liver, renal or metabolic diseases

• Uncontrollable infections

• Coexisting small cell lung cancer

• Psychiatric diseases diagnosed

• Other circumstances which is deemed inappropriate for enrollment by the researchers

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Procedure:
• VATS
Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
• Thoracotomy
Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.

Locations

Country	Name	City	State
China	Beijing Haidian Hospital	Beijing
China	Peking university people's hospital	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha
China	Sir Run Run Shaw Hospital	Hangzhao
China	The Affiliated Hospital of Qingdao University	Qingdao
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The scores of CGA and 4-year mortality index as a measure of predictive factor for the outcome of the elderly.	The scores of prospective CGA and 4-yr mortality index to predict the outcome of the elderly.	3 years	No
Other	The total cost as a measure of the cost/benefit analysis	The cost/benefit analysis of sublobar resection versus lobectomy	3 years	No
Other	The rate of pathologically noninvasive lung cancer with the radiologic character of C/T>0.5	The radiologic character of C/T>0.5 has been considered as a pathologically noninvasive lung cancer. and the rate of pathologically noninvasive lung cancer will be used as a measure for the relation between the radiologic / pathologic character of primary non-small-cell lung cancer and prognosis.	1 month	No
Other	The morbidity rate as a measure between the two different interventions as a Measure of Safety and Tolerability.	The morbidity rate after surgery for participants who underwent video-assisted thoracoscopic or open procedures a Measure of Safety and Tolerability.	3 years	Yes
Primary	Time To Disease free survival Event	The time interval from randomization to the earliest onset of any of the following events: tumor recurrence, metastasis, or death caused by any reason.	3 years	No
Secondary	Percentage of Participants with Perioperative Complication and Death as a Measure of Safety.	Perioperative complication is defined as the complication occurred after surgery and before discharge, or within 30 days postoperatively. Death cases during this period should be recorded as perioperative death.	1 months	Yes
Secondary	Hospitalization time after surgery in Participants	Defined as the time interval from the day of operation to discharge.	1 months	No
Secondary	Intubation time after surgery in Participants	Defined as the time interval from the day of operation to extubation.	1 months	No
Secondary	Time To Overall survival Event	The time interval from randomization to death from any cause.	3 years	No
Secondary	Percentage of Participants With Local Recurrence and Metastasis Event	The ratio of local recurrence and metastasis in 3 years from the day of randomization	3 years	No
Secondary	Postoperative pulmonary function	The Forced expiratory volume in one second and the forced vital capacity at 6-, 12- and 36-month post of the day of randomization.	3 years	No
Secondary	Percentage of Participants With VATS procedure	The ratio of video assisted thoracoscopic surgery in each group.	1 month	No
Secondary	Scores on the quality of life questionaires	The scores of the 6-, 12- and 36-month questionaire on quality of life post of the day of randomization.	3 years	No