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

NCT02360761 | Unknown Phase 3

• 1 other identifier: CTONG1504
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

Lung cancer;Elderly;Sublobar resection;Lobectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Percentage of Participants with Perioperative Complication and Death as a Measure of Safety.

  1 months

• Hospitalization time after surgery in Participants

  1 months

• Intubation time after surgery in Participants

  1 months

• Time To Overall survival Event

  3 years

• Percentage of Participants With Local Recurrence and Metastasis Event

  3 years

Other Outcomes (4)

• The scores of CGA and 4-year mortality index as a measure of predictive factor for the outcome of the elderly.

  3 years

• The total cost as a measure of the cost/benefit analysis

  3 years

• The rate of pathologically noninvasive lung cancer with the radiologic character of C/T>0.5

  1 month

Study Arms (2)

Lobectomy

ACTIVE COMPARATOR

Patients undergo lobectomy by thoracotomy or thoracoscopy/Video assisted thoracoscopic surgery(VATS).

Procedure: VATS; Procedure: Thoracotomy

Sublobar resection

EXPERIMENTAL

Patients undergo sublobar resection(wedge resection or anatomic segmentectomy) by thoracotomy or thoracoscopy/VATS.

Procedure: VATS; Procedure: Thoracotomy

Interventions

VATS PROCEDURE

Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.

Also known as: Thoracoscopy

Lobectomy; Sublobar resection

Thoracotomy PROCEDURE

Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.

Also known as: Open surgery

Lobectomy; Sublobar resection

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 70 years or older
• Preoperative criteria (contrast-enhanced Computed tomography scan)
• Suspected non-small cell lung cancer
• Clinical stage ⅠA, 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (6)

Beijing Haidian Hospital

Beijing, China

RECRUITING

Peking university people's hospital

Beijing, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, China

RECRUITING

Sir Run Run Shaw Hospital

Hangzhao, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

Related Publications (1)

• Yang F, Sui X, Chen X, Zhang L, Wang X, Wang S, Wang J. Sublobar resection versus lobectomy in Surgical Treatment of Elderly Patients with early-stage non-small cell lung cancer (STEPS): study protocol for a randomized controlled trial. Trials. 2016 Apr 7;17:191. doi: 10.1186/s13063-016-1312-6.

  PMID: 27053091 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thoracic Surgery, Video-Assisted; Thoracoscopy; Thoracotomy; Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Jun Wang, M.M.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Wang, M.M.

CONTACT

+8601088326650; Jwangmd@yahoo.com

Fan Yang, M.D.

CONTACT

+86010883266557

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: January 24, 2015
• First Posted: February 11, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

CN (6)