Carcinoma, Non-Small-Cell LungNCT06115239
QOL After SURGERY and ADJUVANT Treatment
An observational study of Carcinoma, Non-Small-Cell Lung and Quality of Life, run by University of Salamanca at 1 site in Spain.
Trial summary
The goal of this prospective, observational study is to measure and analyze the effect of adjuvant treatment over the quality of life and recovery of patients undergoing pulmonary resection because of non-small cells lung cancer using the EORTC-LC29 questionnaire. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Quality of Life
- What is being tested?
- Questionnaires
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- May 2024to Jan 2026
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be formed by patients undergoing pulmonary resection because of lung cancer that are candidates of taking adjuvant treatment after surgery. The patients will be collected from the Thoracic Surgery Department of Hospital Clínico Universitario de Salamanca
Who may be able to join
- Age: 50-85 years old
- Patients with any histological type of non-small-cell lung cancer in clinical stage T1C N0M0 or greater
- Patients that understand the purpose of the study, accept collaborate and sign the informed consent.
Who cannot join
- Patients not receiving adjuvant treatment due to complications, bad quality of life or express rejection at any moment of the curse of the process.
- Patients who cannot complete the previous questionnaires to assess their quality of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Changes in Quality of Life in Patients With Non-small Cell Lung Carcinoma Undergoing Lung Resection Before and After Receiving Adjuvant Treatment Using the EORTC-LC29 Questionnaire
The goal of this prospective, observational study is to measure and analyze the effect of adjuvant treatment over the quality of life and recovery of patients undergoing pulmonary resection because of non-small cells lung cancer using the EORTC-LC29 questionnaire. The main question it aims to answer is:
Whether adjuvant systemic treatment affect or not the postoperative QOL of a NSCLC patient that underwent lung resection
Participants will fulfill two questionnaires (EORTC-LC29 and Hospital Anxiety and Depression Scale) in different stages of their treatment.
Read the detailed description
Despite being surgery the preferred radical treatment of NSCLC in early stages, unforseen N2 disease, larger tumors or bad prognosis histological or molecular findings of the tumor will benefit of receiving adjuvant treatment.
As an adjuvant treatment, postoperative platinum-based chemotherapy has demonstrated its efficacy in increasing survival rates and reducing recurrence rates. Postoperative radiotherapy (RT) is limited due to decreased lung tolerance following surgery and conflicting results.
It is clear that lung cancer significantly impacts the quality of life of patients. According to the Lung Cancer Europe (LuCE) association, a survey conducted in 2021 with 515 patients revealed that 91.2% experienced limitations in their daily lives. Fatigue, sleep problems, cognitive difficulties, and significant reductions in physical activity were the main areas where patients reported the most complications. In addition to the inherent complications of cancer, we must consider the complications associated with surgery and systemic treatment.
Module LC29 is an update of the previous module published by the European Organisation for Research and Treatment of Cancer (EORTC), providing a more current perspective on lung cancer. This latest module retains 12 out of the 13 items from LC13 and adds 17 new items, which gather information on the side effects of medical and targeted therapies, as well as emotional problems. Furthermore, it includes 5 specific questions related to lung surgery. This multidisciplinary approach currently makes the LC29 questionnaire the most comprehensive tool for studying the quality of life of lung cancer patients.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Quality of Life
- Being tested
- Questionnaires
- Keywords
- Non-Small-Cell Lung Cancer, EORTC-LC29, Adjuvant Treatment, Pulmonary Resection, Quality of Life
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Also called Surveys
The patients will fulfill the EORTC-LC29 and HADS questionnaires in 5 different moments.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life before and after adjuvant treatment in patients undergoing pulmonary resection
For quality of life assessment, patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC).
Measured: Pre-surgery, seven days after surgery, before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Secondary outcomes (8)
Correlation between the type of surgical procedure performed and postoperative quality of life
Measure and analyze the correlation between the type of surgical procedure performed and postoperative quality of life upon completion of the surgical episode and before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). The type of surgical procedure (segmentectomy, lobectomy or pneumonectomy), will be collected from the post-surgery report.
Measured: Before surgery, seven days after surgery
Correlation between the type of surgical approach performed and postoperative quality of life
Measure and analyze the correlation between the type of surgical approach performed and postoperative quality of life upon completion of the surgical episode and before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). The type of surgical approach (thoracotomy, VATS or RATS), will be collected from the post-surgery report.
Measured: Before surgery, seven days after surgery
Correlation between the occurrence of postoperative complications and a longer hospital stay
Analyze the correlation between the occurrence of postoperative complications and a longer hospital stay with the quality of life before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). Post-surgery complications will be collected from the patient's medical record, recorded in the Jimena 4 software program. Hospital stay lenght will be collected from the patient´s hospital discharge report.
Measured: Before surgery, seven days after surgery, before the first dose of adjuvant treatment
Effect of complications from adjuvant treatment on the surgical items of the EORTC-LC29
Measure and analyze the effect of complications from adjuvant treatment on the surgical items of the EORTC-LC29 for patients undergoing lung resection for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC), where higher score represents higher level of symptomatology or problems.
Measured: Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Adjuvant chemotherapy/immunotherapy treatment regimen significantly decreases the quality of life
Measure and analyze whether any adjuvant chemotherapy/immunotherapy treatment regimen significantly decreases the quality of life of patients who receive adjuvant treatment after undergoing lung resection compared to others.
Measured: Before the first cycle of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Correlation between the presence of Chronic Obstructive Pulmonary Disease (COPD) and postoperative quality of life
Analyze the correlation between the presence of Chronic Obstructive Pulmonary Disease (COPD) and postoperative quality of life upon completion of the surgical episode before and after receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC).
Measured: Before surgery, seven days after surgery, before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Level of anxiety/depression in patients undergoing lung resection before and after receiving the first cycle of adjuvant treatment
Measure and analyze the level of anxiety/depression in patients undergoing lung resection before and after receiving the first cycle of adjuvant treatment for lung cancer. Patients will be asked to complete the HADS questionnaire.
Measured: Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Effect of Performance Status (PS) and pre-adjuvant treatment ECOG on the quality of life after receiving the first cycle of any treatment modality.
Measure and analyze the effect of Performance Status (PS) and pre-adjuvant treatment ECOG on the quality of life after receiving the first cycle of any treatment modality. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). Performance Status Score and ECOG score data will be collected from the patient's medical record, recorded in the Jimena 4 software program.
Measured: Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study startMay 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Fernandez Salvador, University of Salamanca
- Investigators
- Pablo Fernández Salvador, Nurse, Principal investigator, University of SalamancaNuria M Novoa Valentín, MD, PhD, Study director, University of SalamancaMarta G Fuentes Gago, MD, PhD, Study director, University of SalamancaMaría B García Cenador, MD, PhD, Study chair, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115239
- Sponsor's protocol ID
- PI 2023 05 1296 - TD
- Status last verified
- May 2024
- First submitted
- 16 Oct 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
PubMed 36633525Nicholson AG, Tsao MS, Beasley MB, Borczuk AC, Brambilla E, Cooper WA, Dacic S, Jain D, Kerr KM, Lantuejoul S, Noguchi M, Papotti M, Rekhtman N, Scagliotti G, van Schil P, Sholl L, Yatabe Y, Yoshida A, Travis WD. The 2021 WHO Classification of Lung Tumors: Impact of Advances Since 2015. J Thorac Oncol. 2022 Mar;17(3):362-387. doi: 10.1016/j.jtho.2021.11.003. Epub 2021 Nov 20.
PubMed 34808341Ettinger DS, Wood DE, Aisner DL, Akerley W, Bauman JR, Bharat A, Bruno DS, Chang JY, Chirieac LR, D'Amico TA, DeCamp M, Dilling TJ, Dowell J, Gettinger S, Grotz TE, Gubens MA, Hegde A, Lackner RP, Lanuti M, Lin J, Loo BW, Lovly CM, Maldonado F, Massarelli E, Morgensztern D, Ng T, Otterson GA, Pacheco JM, Patel SP, Riely GJ, Riess J, Schild SE, Shapiro TA, Singh AP, Stevenson J, Tam A, Tanvetyanon T, Yanagawa J, Yang SC, Yau E, Gregory K, Hughes M. Non-Small Cell Lung Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 May;20(5):497-530. doi: 10.6004/jnccn.2022.0025.
PubMed 35545176Shi Y, Wu S, Ma S, Lyu Y, Xu H, Deng L, Chen X. Comparison Between Wedge Resection and Lobectomy/Segmentectomy for Early-Stage Non-small Cell Lung Cancer: A Bayesian Meta-analysis and Systematic Review. Ann Surg Oncol. 2022 Mar;29(3):1868-1879. doi: 10.1245/s10434-021-10857-7. Epub 2021 Oct 6.
PubMed 34613537Atkins BZ, Harpole DH Jr, Mangum JH, Toloza EM, D'Amico TA, Burfeind WR Jr. Pulmonary segmentectomy by thoracotomy or thoracoscopy: reduced hospital length of stay with a minimally-invasive approach. Ann Thorac Surg. 2007 Oct;84(4):1107-12; discussion 1112-3. doi: 10.1016/j.athoracsur.2007.05.013.
PubMed 17888955Scott WJ, Allen MS, Darling G, Meyers B, Decker PA, Putnam JB, McKenna RW, Landrenau RJ, Jones DR, Inculet RI, Malthaner RA. Video-assisted thoracic surgery versus open lobectomy for lung cancer: a secondary analysis of data from the American College of Surgeons Oncology Group Z0030 randomized clinical trial. J Thorac Cardiovasc Surg. 2010 Apr;139(4):976-81; discussion 981-3. doi: 10.1016/j.jtcvs.2009.11.059. Epub 2010 Feb 20.
PubMed 20172539Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009.
PubMed 19022040Pignon JP, Tribodet H, Scagliotti GV, Douillard JY, Shepherd FA, Stephens RJ, Dunant A, Torri V, Rosell R, Seymour L, Spiro SG, Rolland E, Fossati R, Aubert D, Ding K, Waller D, Le Chevalier T; LACE Collaborative Group. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008 Jul 20;26(21):3552-9. doi: 10.1200/JCO.2007.13.9030. Epub 2008 May 27.
PubMed 18506026Butts CA, Ding K, Seymour L, Twumasi-Ankrah P, Graham B, Gandara D, Johnson DH, Kesler KA, Green M, Vincent M, Cormier Y, Goss G, Findlay B, Johnston M, Tsao MS, Shepherd FA. Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10. J Clin Oncol. 2010 Jan 1;28(1):29-34. doi: 10.1200/JCO.2009.24.0333. Epub 2009 Nov 23.
PubMed 19933915Wang SF, Mao NQ, Zhao WH, Pan XB. Postoperative radiotherapy in pIIIA-N2 non-small cell lung cancer after complete resection and adjuvant chemotherapy: A meta-analysis. Medicine (Baltimore). 2022 Jul 15;101(28):e29550. doi: 10.1097/MD.0000000000029550.
PubMed 35839025Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.
PubMed 29658848Shukla N, Hanna N. Neoadjuvant and Adjuvant Immunotherapy in Early-Stage Non-Small Cell Lung Cancer. Lung Cancer (Auckl). 2021 Jun 28;12:51-60. doi: 10.2147/LCTT.S277717. eCollection 2021.
PubMed 34234606Broderick SR. Adjuvant and Neoadjuvant Immunotherapy in Non-small Cell Lung Cancer. Thorac Surg Clin. 2020 May;30(2):215-220. doi: 10.1016/j.thorsurg.2020.01.001.
PubMed 32327180Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gumus M, Mazieres J, Hermes B, Cay Senler F, Csoszi T, Fulop A, Rodriguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. doi: 10.1056/NEJMoa1810865. Epub 2018 Sep 25.
PubMed 30280635Gabay C, Russo A, Raez LE, Rolfo Cervetto C. Adjuvant therapy in non-small cell lung cancer: is targeted therapy joining the standard of care? Expert Rev Anticancer Ther. 2021 Nov;21(11):1229-1235. doi: 10.1080/14737140.2021.1982387. Epub 2021 Sep 25.
PubMed 34528869
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Quality of Life in Patients With Non-small Cell Lung Carcinoma Undergoing Lung Resection Before and After Receiving Adjuvant Treatment Using the EORTC-LC29 Questionnaire
- ClinicalTrials.gov ID
- NCT06115239
- Acronym / sponsor ID
- PI 2023 05 1296 - TD
- Conditions
- Carcinoma, Non-Small-Cell Lung, Quality of Life
- Keywords
- Non-Small-Cell Lung Cancer, EORTC-LC29, Adjuvant Treatment, Pulmonary Resection, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective, observational study is to measure and analyze the effect of adjuvant treatment over the quality of life and recovery of patients undergoing pulmonary resection because of non-small cells lung cancer using the EORTC-LC29 questionnaire. The main question it aims to answer is:
Whether adjuvant systemic treatment affect or not the postoperative QOL of a NSCLC patient that underwent lung resection
Participants will fulfill two questionnaires (EORTC-LC29 and Hospital Anxiety and Depression Scale) in different stages of their treatment.
Detailed description
Despite being surgery the preferred radical treatment of NSCLC in early stages, unforseen N2 disease, larger tumors or bad prognosis histological or molecular findings of the tumor will benefit of receiving adjuvant treatment.
As an adjuvant treatment, postoperative platinum-based chemotherapy has demonstrated its efficacy in increasing survival rates and reducing recurrence rates. Postoperative radiotherapy (RT) is limited due to decreased lung tolerance following surgery and conflicting results.
It is clear that lung cancer significantly impacts the quality of life of patients. According to the Lung Cancer Europe (LuCE) association, a survey conducted in 2021 with 515 patients revealed that 91.2% experienced limitations in their daily lives. Fatigue, sleep problems, cognitive difficulties, and significant reductions in physical activity were the main areas where patients reported the most complications. In addition to the inherent complications of cancer, we must consider the complications associated with surgery and systemic treatment.
Module LC29 is an update of the previous module published by the European Organisation for Research and Treatment of Cancer (EORTC), providing a more current perspective on lung cancer. This latest module retains 12 out of the 13 items from LC13 and adds 17 new items, which gather information on the side effects of medical and targeted therapies, as well as emotional problems. Furthermore, it includes 5 specific questions related to lung surgery. This multidisciplinary approach currently makes the LC29 questionnaire the most comprehensive tool for studying the quality of life of lung cancer patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be formed by patients undergoing pulmonary resection because of lung cancer that are candidates of taking adjuvant treatment after surgery. The patients will be collected from the Thoracic Surgery Department of Hospital Clínico Universitario de Salamanca
Key inclusion criteria (3 listed)
- Age: 50-85 years old
- Patients with any histological type of non-small-cell lung cancer in clinical stage T1C N0M0 or greater
- Patients that understand the purpose of the study, accept collaborate and sign the informed consent.
Key exclusion criteria (2 listed)
- Patients not receiving adjuvant treatment due to complications, bad quality of life or express rejection at any moment of the curse of the process.
- Patients who cannot complete the previous questionnaires to assess their quality of life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: SurveysThe patients will fulfill the EORTC-LC29 and HADS questionnaires in 5 different moments. | Other | – |
Primary outcome
Quality of life before and after adjuvant treatment in patients undergoing pulmonary resection
Time frame: Pre-surgery, seven days after surgery, before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
For quality of life assessment, patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC).
8 secondary outcomes
Correlation between the type of surgical procedure performed and postoperative quality of life
Time frame: Before surgery, seven days after surgery
Correlation between the type of surgical approach performed and postoperative quality of life
Time frame: Before surgery, seven days after surgery
Correlation between the occurrence of postoperative complications and a longer hospital stay
Time frame: Before surgery, seven days after surgery, before the first dose of adjuvant treatment
Effect of complications from adjuvant treatment on the surgical items of the EORTC-LC29
Time frame: Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Adjuvant chemotherapy/immunotherapy treatment regimen significantly decreases the quality of life
Time frame: Before the first cycle of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Correlation between the presence of Chronic Obstructive Pulmonary Disease (COPD) and postoperative quality of life
Time frame: Before surgery, seven days after surgery, before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Level of anxiety/depression in patients undergoing lung resection before and after receiving the first cycle of adjuvant treatment
Time frame: Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Effect of Performance Status (PS) and pre-adjuvant treatment ECOG on the quality of life after receiving the first cycle of any treatment modality.
Time frame: Before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 36633525Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
- Background: PubMed 34808341Nicholson AG, Tsao MS, Beasley MB, Borczuk AC, Brambilla E, Cooper WA, Dacic S, Jain D, Kerr KM, Lantuejoul S, Noguchi M, Papotti M, Rekhtman N, Scagliotti G, van Schil P, Sholl L, Yatabe Y, Yoshida A, Travis WD. The 2021 WHO Classification of Lung Tumors: Impact of Advances Since 2015. J Thorac Oncol. 2022 Mar;17(3):362-387. doi: 10.1016/j.jtho.2021.11.003. Epub 2021 Nov 20.
- Background: PubMed 35545176Ettinger DS, Wood DE, Aisner DL, Akerley W, Bauman JR, Bharat A, Bruno DS, Chang JY, Chirieac LR, D'Amico TA, DeCamp M, Dilling TJ, Dowell J, Gettinger S, Grotz TE, Gubens MA, Hegde A, Lackner RP, Lanuti M, Lin J, Loo BW, Lovly CM, Maldonado F, Massarelli E, Morgensztern D, Ng T, Otterson GA, Pacheco JM, Patel SP, Riely GJ, Riess J, Schild SE, Shapiro TA, Singh AP, Stevenson J, Tam A, Tanvetyanon T, Yanagawa J, Yang SC, Yau E, Gregory K, Hughes M. Non-Small Cell Lung Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 May;20(5):497-530. doi: 10.6004/jnccn.2022.0025.
- Background: PubMed 34613537Shi Y, Wu S, Ma S, Lyu Y, Xu H, Deng L, Chen X. Comparison Between Wedge Resection and Lobectomy/Segmentectomy for Early-Stage Non-small Cell Lung Cancer: A Bayesian Meta-analysis and Systematic Review. Ann Surg Oncol. 2022 Mar;29(3):1868-1879. doi: 10.1245/s10434-021-10857-7. Epub 2021 Oct 6.
- Background: PubMed 17888955Atkins BZ, Harpole DH Jr, Mangum JH, Toloza EM, D'Amico TA, Burfeind WR Jr. Pulmonary segmentectomy by thoracotomy or thoracoscopy: reduced hospital length of stay with a minimally-invasive approach. Ann Thorac Surg. 2007 Oct;84(4):1107-12; discussion 1112-3. doi: 10.1016/j.athoracsur.2007.05.013.
- Background: PubMed 20172539Scott WJ, Allen MS, Darling G, Meyers B, Decker PA, Putnam JB, McKenna RW, Landrenau RJ, Jones DR, Inculet RI, Malthaner RA. Video-assisted thoracic surgery versus open lobectomy for lung cancer: a secondary analysis of data from the American College of Surgeons Oncology Group Z0030 randomized clinical trial. J Thorac Cardiovasc Surg. 2010 Apr;139(4):976-81; discussion 981-3. doi: 10.1016/j.jtcvs.2009.11.059. Epub 2010 Feb 20.
- Background: PubMed 19022040Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009.
- Background: PubMed 18506026Pignon JP, Tribodet H, Scagliotti GV, Douillard JY, Shepherd FA, Stephens RJ, Dunant A, Torri V, Rosell R, Seymour L, Spiro SG, Rolland E, Fossati R, Aubert D, Ding K, Waller D, Le Chevalier T; LACE Collaborative Group. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008 Jul 20;26(21):3552-9. doi: 10.1200/JCO.2007.13.9030. Epub 2008 May 27.
- Background: PubMed 19933915Butts CA, Ding K, Seymour L, Twumasi-Ankrah P, Graham B, Gandara D, Johnson DH, Kesler KA, Green M, Vincent M, Cormier Y, Goss G, Findlay B, Johnston M, Tsao MS, Shepherd FA. Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10. J Clin Oncol. 2010 Jan 1;28(1):29-34. doi: 10.1200/JCO.2009.24.0333. Epub 2009 Nov 23.
- Background: PubMed 35839025Wang SF, Mao NQ, Zhao WH, Pan XB. Postoperative radiotherapy in pIIIA-N2 non-small cell lung cancer after complete resection and adjuvant chemotherapy: A meta-analysis. Medicine (Baltimore). 2022 Jul 15;101(28):e29550. doi: 10.1097/MD.0000000000029550.
- Background: PubMed 29658848Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.
- Background: PubMed 34234606Shukla N, Hanna N. Neoadjuvant and Adjuvant Immunotherapy in Early-Stage Non-Small Cell Lung Cancer. Lung Cancer (Auckl). 2021 Jun 28;12:51-60. doi: 10.2147/LCTT.S277717. eCollection 2021.
- Individual participant dataSharing planned: Yes
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Lung Cancer
RecruitingPhase 2
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Fernández Salvador, Nurse principal investigator
University of Salamanca
Nuria M Novoa Valentín, MD, PhD study director
University of Salamanca
Marta G Fuentes Gago, MD, PhD study director
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung and Quality of Life, run by University of Salamanca at 1 site in Spain.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo Fernández Salvador, Nurse (+34 689147857, pfs45@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life before and after adjuvant treatment in patients undergoing pulmonary resection (time frame: Pre-surgery, seven days after surgery, before the first dose of adjuvant treatment, 2 days after the first dose of adjuvant treatment, 2 days after finishing the whole cycle of adjuvant treatment). 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 NCT06115239, which also lists 21 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 7 May 2024.