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Patient Outcome AssessmentSRaITNCT04092465

Outcomes of Surgical Resection After Induction Treatment in Non-Small Cell Lung Cancer (SRaIT)

An observational study of Patient Outcome Assessment and Morbidity, run by AHEPA University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Surgery still remains the main treatment option for Non-Small Cell Lung Cancer (NSCLC) which is limited within the lung parenchyma and possibly invades the intrapulmonary or hilar nodes. Read more about this study

Who is it for?
Any age
Conditions the study is for
Patient Outcome Assessment, Morbidity, Mortality
What is being tested?
Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomy
Type of treatment
Surgery or procedure
How many people
42 participants
Where
No sites listed yet
Study dates
30 Sep 2011to 31 Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients who underwent resection with curative intent of their locally advanced NSCLC after induction treatment in a single Academic Center from September 2011 to August 2019 (8 years). Surgery was applied either in downstaged tumors os as salvage extended surgery in patients not responding to induction treatment.

Who may be able to join

  • Patients who underwent surgery for NSCLC after induction treatment

Who cannot join

  • Patients who underwent surgery fo NSCLC located in the superior sulcus and Pancoast syndrome.

About this study

Official title: Short and Long Term Outcomes of Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Pulmonary Parenchyma Resection After Induction Treatment.

Surgery still remains the main treatment option for Non-Small Cell Lung Cancer (NSCLC) which is limited within the lung parenchyma and possibly invades the intrapulmonary or hilar nodes. The role of surgery in locally advanced NSCLC with the form of invasion of adjacent strictures or mediastinal nodes is a 30-year point of discussion and debate among thoracic surgeons, clinical and radiation oncologists, chest physicians and other related specialties. Despite the continuous debate the management of locally advanced NSCLC varies between different countries and different institutions.We try to investigate the short and long term outcomes of surgery after induction treatment performed for locally advanced NSCLC.

Read the detailed description

All patients who underwent surgery with curative intent or salvage after induction treatment during a 8-year time period (2011-2019). Induction treatment with the form either of chemotherapy or chemoradiotherapy was delivered according to the thoracic multidisciplinary team decision which it was based on primary tumor histology and stage. Patients with Pancoast tumors were excluded from the study design, because these tumors have different clinical characteristics and represent a separate category of NSCLC with a well recognized specific treatment plan worldwide.

Overall 42 patients are included in the study and the recorded parameters in each patient are:

  1. Age, gender, comorbidities, histology, location in the lung and stage of tumor at presentation, tools used for preoperative staging in each case, any previous surgical procedures of other treatments performed before elsewhere, type of induction treatment, tools used for tumor restaging.
  2. In each patient were recorded any specific technical details concerning the applied surgical procedures, time of surgery and one-lung ventilation (OLV), postoperative complications and their management, mortality, pos-resection staging (ypTNM), the number of resected lymph nodes in each patient.
  3. Concerning the long term outcomes, overall and disease-free survival, kind of recurrence (local, distant, combination) and treatment of recurrences were recorded.

Interpretation fo the results will include the correlation of surgical details, kind and dose of induction treatment with postoperative complications, especially infectious complications and prolonged air leaks. Radicality of the resection and response of the tumor to induction treatment (ypTNM stage) as it is recorded in histology reports are the two important clinical parameters to be studied for their effect on long term survival and recurrences.

Surgery was applied as salvage surgery in not well responded tumors or as resection of downstaged tumors.

Being tested
Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomy
Keywords
NSCLC, Locally Advanced NSCLC, Induction treatment, Induction chemotherapy, Induction chemoradiotherapy, Pulmonary Parenchyma Resection, Surgical Outcomes, Survival, Morbidity, Thoracotomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomyProcedure or surgery

    Also called induction chemotherapy, induction chemoradiotherapy

    Resection of the downstaged locally advanced NSCLC through formal thoracotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality-Morbidity

    Mortality and morbidity of the pulmonary parenchyma resection for NSCLC after induction treatment

    Measured: From date of surgery until 12 weeks after surgery

  2. Long term survival of patients and correlation of long term survival with the post-resection stage of tumor (ypTNM stage)

    Close clinical follow-up by clinical oncologists and surgeons to detect and treat

    Measured: From the date of surgery to up to 96 months after surgery

  3. Recurrence of tumor - Disease free survival

    Close clinical follow-up by clinical oncologists and surgeons to detect and treat recurrences. Correlation of recurrences with post-resection (ypTNM) stage of tumor, completeness of resection, type of surgical procedure

    Measured: From date of surgery to up to 96 months after surgery

Secondary outcomes (3)

  1. Specific details concerning the surgical procedures and correlation with morbidity

    Extended procedures, intrapericardial procedures, pneumonectomy

    Measured: From time of surgery to up to 12 weeks after surgery

  2. Respiratory complications

    Correlation of the overall time required for the procedure and of the time of one lung ventilation with the rate and kind of respiratory complications and ICU stay

    Measured: From time of surgery to up to 12 weeks after surgery

  3. Postoperative complications

    Correlation of kind and overall dose of the delivered chemotherapy or radiotherapy with the development of postoperative complications, especially prolonged air leak and infectious complications

    Measured: From time of surgery to up to 12 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2019
  2. Study start30 Sep 2011
  3. Primary completion31 Aug 2019
  4. Study completion31 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04092465
Sponsor's protocol ID
425/12-9-2019
Acronym
SRaIT
Status last verified
Sep 2019
First submitted
31 Aug 2019
Last updated
17 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shepherd FA. Induction chemotherapy for locally advanced non-small cell lung cancer. Ann Thorac Surg. 1993 Jun;55(6):1585-92. doi: 10.1016/0003-4975(93)91123-5.

    PubMed 8390231

  • Rusch VW, Albain KS, Crowley JJ, Rice TW, Lonchyna V, McKenna R Jr, Livingston RB, Griffin BR, Benfield JR. Surgical resection of stage IIIA and stage IIIB non-small-cell lung cancer after concurrent induction chemoradiotherapy. A Southwest Oncology Group trial. J Thorac Cardiovasc Surg. 1993 Jan;105(1):97-104; discussion 104-6.

    PubMed 8380477

  • Albain KS, Rusch VW, Crowley JJ, Rice TW, Turrisi AT 3rd, Weick JK, Lonchyna VA, Presant CA, McKenna RJ, Gandara DR, et al. Concurrent cisplatin/etoposide plus chest radiotherapy followed by surgery for stages IIIA (N2) and IIIB non-small-cell lung cancer: mature results of Southwest Oncology Group phase II study 8805. J Clin Oncol. 1995 Aug;13(8):1880-92. doi: 10.1200/JCO.1995.13.8.1880.

    PubMed 7636530

  • Sonett JR, Suntharalingam M, Edelman MJ, Patel AB, Gamliel Z, Doyle A, Hausner P, Krasna M. Pulmonary resection after curative intent radiotherapy (>59 Gy) and concurrent chemotherapy in non-small-cell lung cancer. Ann Thorac Surg. 2004 Oct;78(4):1200-5; discussion 1206. doi: 10.1016/j.athoracsur.2004.04.085.

    PubMed 15464470

  • Kumar P, Herndon J 2nd, Langer M, Kohman LJ, Elias AD, Kass FC, Eaton WL, Seagren SL, Green MR, Sugarbaker DJ. Patterns of disease failure after trimodality therapy of nonsmall cell lung carcinoma pathologic stage IIIA (N2). Analysis of Cancer and Leukemia Group B Protocol 8935. Cancer. 1996 Jun 1;77(11):2393-9. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-Q.

    PubMed 8635112

Questions about this trial

What is this clinical trial studying?

An observational study of Patient Outcome Assessment and Morbidity, run by AHEPA University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality-Morbidity (time frame: From date of surgery until 12 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04092465, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.

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