Small Cell Lung CarcinomaNCT06529081
Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer
A study testing Palliative Radiotherapy and Radical/Ablative Radiotherapy in people with Small Cell Lung Carcinoma, run by Copernicus Memorial Hospital at 2 sites in Poland.
Trial summary
The purpose of this study is to evaluate the efficacy of radiotherapy as part of the combined treatment approach for patients diagnosed with histopathologically confirmed small cell lung cancer (SCLC) in the advanced stage of extensive disease (ED) who are undergoing chemo-immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Palliative Radiotherapy and Radical/Ablative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Apr 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological confirmation of small cell lung cancer based on histological or cytological examination.
- Primary clinical stage: Extensive stage of the disease according to VASLG classification or stage IV according to TNM classification.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 prior to randomization.
- Partial response (PR) or stable disease (SD) to platinum-based doublet chemotherapy with durvalumab or atezolizumab based on restaging (positron emission tomography [PET]/computed tomography [CT] or CT or magnetic resonance imaging [MRI]).
- Ability to undergo radiotherapy at a total dose of 45 Gy in 15 daily fractions of 3 Gy to the chest area and a total dose of 24 Gy administered in single fractions every 2-3 days of 8 Gy to the metastatic lesions.
- Clinical control of brain metastases (prior whole-brain irradiation at any stage is acceptable before study entry).
Show all 12Show fewer
- Measurable residual disease after chemioimmunotherapy (according to RECIST 1.1 solid tumor response assessment criteria) or in case of CR/PR presence of tumor lesions not classified as measurable.
- Volume and number (up to 10) of metastatic lesions allowing for radiotherapy in doses according to the study protocol.
- Absence of clinically significant and uncontrolled co-morbidities with pharmacological treatment.
- Absence of active autoimmune diseases except for diabetes, hypothyroidism, psoriasis, eczema, lichen planus, and vitiligo.
- Adequate hematopoietic function allowing treatment with atezolizumab or durvalumab, according to the current SmPC (Summary of Product Characteristics).
- Renal and hepatic function allowing treatment according to the current SmPC for atezolizumab or durvalumab.
Who cannot join
- Age under 18 years old.
- Premenopausal women who do not accept the need for effective contraception during radiotherapy and/or chemotherapy/immunotherapy.
- Individuals excluded from participation in a medical experiment based on Article 23A(1) of the Act on the Profession of Physician and Pharmacist.
- Coexistence of other uncontrolled malignant neoplasms.
- Contraindications to the use of atezolizumab or durvalumab as specified in the SmPC.
- Grade 2 or greater CTCAE v.5 pneumonitis secondary to immunotherapy.
Show all 9Show fewer
- Participation in another clinical trial during the study.
- Prior chest radiotherapy that precludes safe administration of radiotherapy according to the study protocol. Prior palliative radiotherapy to metastatic sites is acceptable before study entry if clinically indicated as determined by the physician.
- Contraindications to radiotherapy according to the approved protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Copernicus Memorial Hospital in Łódź
Lodz, Łódź Voivodeship, 93-513
Łukasz Kuncman, PhD, lm.kuncman@kopernik.lodz.pl
- Recruiting
Center of Oncology of the Lublin Region St. Jana z Dukli in Lublin
Lublin
Mateusz Bilski, PhD, +4881 454 13 71, matbilski@gmail.com
Katarzyna Kwiatkowska, kkwiatkowska@cozl.pl
About this study
Official title: Assessment of Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer at the Stage of Extensive Disease - a Research Experiment
The purpose of this study is to evaluate the efficacy of radiotherapy as part of the combined treatment approach for patients diagnosed with histopathologically confirmed small cell lung cancer (SCLC) in the advanced stage of extensive disease (ED) who are undergoing chemo-immunotherapy. The planned study aims to assess the impact of incorporating consolidative radiotherapy into the treatment strategy, focusing on residual changes following chemo-immunotherapy (during immunotherapy) and its effect on progression-free survival.
This research experiment will be conducted as a randomized multi-center study, comprising the following treatment arms:
Read more
- Arm I: Continuation of standard of care - PDL1/PD1 immunotherapy (durvalumab or atezolozumab) after chemo-immunotherapy based on platinum compounds;
- Arm II: Standard of care, followed by consolidating radiotherapy of the chest area and possibly metastases (if indicated) in doses and for palliative indications (total dose of 30 Gy in 10 daily doses of 3 Gy each);
- Arm III: Standard of care, followed by consolidating radiotherapy in the radical/ablative doses (total dose of 45 Gy delivered in 15 daily fractions of 3 Gy for the chest area, and total dose of 24 Gy in single fractions of 8 Gy administered every 2-3 days for the metastatic lesions) of the chest area and all metastatic lesions.
Additionally, as part of routine weekly blood collections, an extra volume of 10 ml of blood will be collected. This additional blood sample will be obtained before starting radiotherapy, during each week of radiotherapy (maximum three collections), and at the time of disease progression (one collection), resulting in a total of five extra samples. The collected blood will be prepared, stored and used for circulating tumor DNA (ctDNA) testing, according to the protocol. The ctDNA analysis data will be utilized as a potential marker to determine the time to progression and assess the benefits derived from the administered radiotherapy.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Palliative Radiotherapy, Radical/Ablative Radiotherapy
- Keywords
- Small Cell Lung Carcinoma, Extensive Disease, Chemo-immunotherapy, Radiotherapy, Durvalumab, Atezolizumab, Immunotherapy
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative RadiotherapyRadiation
Standard treatment with added consolidative radiotherapy to the chest area and possibly metastatic lesions (if indicated) in doses and for palliative indications (total dose of 30 Gy in 10 daily doses of 3 Gy each).
Radical/Ablative RadiotherapyRadiation
Standard treatment with added radical/ablative radiotherapy (total dose of 45 Gy in 15 daily fractions of 3 Gy to the chest area and total dose of 24 Gy administered in single fractions of 8 Gy every 2-3 days to the metastatic lesions) to the chest area and all metastatic lesions.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | No intervention | PDL1/PD1 immunotherapy (durvalumab or atezolozumab - according to the SmPC) after chemo-immunotherapy based on platinum compounds. |
| Standard Treatment with Palliative Radiotherapy | Experimental | Not described Receives: Radiation: Palliative Radiotherapy |
| Standard Treatment with Radical/Ablative Radiotherapy | Experimental | Not described Receives: Radiation: Radical/Ablative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) according to RECIST 1.1 imaging criteria or patient death.
The assessment of the impact of consolidative (radical/palliative) radiotherapy on residual post-chemoimmunotherapy (during immunotherapy) lesions on progression-free survival (PFS).
Measured: 12 months after last patient entry
Secondary outcomes (5)
Overall survival.
Measured: At the end of the study (an average of 1 year after last patient entry).
Treatment toxicity (incidence of Grade 3 toxicity according to CTCAE v.5).
Measured: At the end of the study (an average of 1 year after last patient entry).
Site of progression (primary lesions [present at baseline]/new lesions).
Measured: At the end of the study (an average of 1 year after last patient entry).
Objective response rate (ORR).
Measured: At the end of the study (an average of 1 year after last patient entry).
Response rate in nonirradiated lesions.
Measured: At the end of the study (an average of 1 year after last patient entry).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copernicus Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Principal investigator, Łukasz Kuncman, Copernicus Memorial Hospital
- Investigators
- Łukasz Kuncman, PhD, Principal investigator, Department of Radiotherapy, Copernicus Memoriał Hospital in Łódź, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529081
- Sponsor's protocol ID
- 2023/ABM/01/00040
- Status last verified
- Aug 2025
- First submitted
- 26 Jul 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125. doi: 10.1016/S1470-2045(17)30318-2. Epub 2017 Jun 20.
PubMed 28642008Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
PubMed 30280641Slotman BJ, van Tinteren H, Praag JO, Knegjens JL, El Sharouni SY, Hatton M, Keijser A, Faivre-Finn C, Senan S. Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial. Lancet. 2015 Jan 3;385(9962):36-42. doi: 10.1016/S0140-6736(14)61085-0. Epub 2014 Sep 14.
PubMed 25230595Goldman JW, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Garassino MC, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Thiyagarajah P, Jiang H, Paz-Ares L; CASPIAN investigators. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):51-65. doi: 10.1016/S1470-2045(20)30539-8. Epub 2020 Dec 4.
PubMed 33285097Gore EM, Hu C, Sun AY, Grimm DF, Ramalingam SS, Dunlap NE, Higgins KA, Werner-Wasik M, Allen AM, Iyengar P, Videtic GMM, Hales RK, McGarry RC, Urbanic JJ, Pu AT, Johnstone CA, Stieber VW, Paulus R, Bradley JD. Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extracranial Irradiation for Extensive-Disease Small Cell Lung Cancer (ED SCLC): NRG Oncology RTOG 0937. J Thorac Oncol. 2017 Oct;12(10):1561-1570. doi: 10.1016/j.jtho.2017.06.015. Epub 2017 Jun 23.
PubMed 28648948Timmerman R. A Story of Hypofractionation and the Table on the Wall. Int J Radiat Oncol Biol Phys. 2022 Jan 1;112(1):4-21. doi: 10.1016/j.ijrobp.2021.09.027. No abstract available.
PubMed 34919882Herbreteau G, Langlais A, Greillier L, Audigier-Valette C, Uwer L, Hureaux J, Moro-Sibilot D, Guisier F, Carmier D, Madelaine J, Otto J, Souquet PJ, Gounant V, Merle P, Molinier O, Renault A, Rabeau A, Morin F, Denis MG, Pujol JL. Circulating Tumor DNA as a Prognostic Determinant in Small Cell Lung Cancer Patients Receiving Atezolizumab. J Clin Med. 2020 Nov 27;9(12):3861. doi: 10.3390/jcm9123861.
PubMed 33261056Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.
PubMed 6354290Kuncman L, Fijuth J, Tworek D, Sierko E, Cisek P, Maslowski M, Lisik-Habib M, Orzechowska M, Galwas-Kliber K, Antczak A, Chmielewska I, Ziolkowska B, Kurczewska-Michalak M, Kuznicki W, Jedrzejczak N, Ranoszek K, Bilski M. Radiotherapy(R) Integration(I) Strategy for Small(S)-Cell Lung Cancer in Extensive(E) Stage (RISE) with up to 10 metastases- a study protocol of a randomized phase II trial. BMC Cancer. 2025 Jan 24;25(1):142. doi: 10.1186/s12885-025-13552-y.
PubMed 39856583
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer at the Stage of Extensive Disease - a Research Experiment
- ClinicalTrials.gov ID
- NCT06529081
- Acronym / sponsor ID
- 2023/ABM/01/00040
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- Small Cell Lung Carcinoma, Extensive Disease, Chemo-immunotherapy, Radiotherapy, Durvalumab, Atezolizumab, Immunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Copernicus Memorial HospitalUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 31 Jul 2024 (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 purpose of this study is to evaluate the efficacy of radiotherapy as part of the combined treatment approach for patients diagnosed with histopathologically confirmed small cell lung cancer (SCLC) in the advanced stage of extensive disease (ED) who are undergoing chemo-immunotherapy. The planned study aims to assess the impact of incorporating consolidative radiotherapy into the treatment strategy, focusing on residual changes following chemo-immunotherapy (during immunotherapy) and its effect on progression-free survival.
This research experiment will be conducted as a randomized multi-center study, comprising the following treatment arms:
- Arm I: Continuation of standard of care - PDL1/PD1 immunotherapy (durvalumab or atezolozumab) after chemo-immunotherapy based on platinum compounds;
- Arm II: Standard of care, followed by consolidating radiotherapy of the chest area and possibly metastases (if indicated) in doses and for palliative indications (total dose of 30 Gy in 10 daily doses of 3 Gy each);
- Arm III: Standard of care, followed by consolidating radiotherapy in the radical/ablative doses (total dose of 45 Gy delivered in 15 daily fractions of 3 Gy for the chest area, and total dose of 24 Gy in single fractions of 8 Gy administered every 2-3 days for the metastatic lesions) of the chest area and all metastatic lesions.
Additionally, as part of routine weekly blood collections, an extra volume of 10 ml of blood will be collected. This additional blood sample will be obtained before starting radiotherapy, during each week of radiotherapy (maximum three collections), and at the time of disease progression (one collection), resulting in a total of five extra samples. The collected blood will be prepared, stored and used for circulating tumor DNA (ctDNA) testing, according to the protocol. The ctDNA analysis data will be utilized as a potential marker to determine the time to progression and assess the benefits derived from the administered radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | No intervention | –PDL1/PD1 immunotherapy (durvalumab or atezolozumab - according to the SmPC) after chemo-immunotherapy based on platinum compounds. |
| Standard Treatment with Palliative Radiotherapy | Experimental | Radiation: Palliative Radiotherapy |
| Standard Treatment with Radical/Ablative Radiotherapy | Experimental | Radiation: Radical/Ablative Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histopathological confirmation of small cell lung cancer based on histological or cytological examination.
- Primary clinical stage: Extensive stage of the disease according to VASLG classification or stage IV according to TNM classification.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 prior to randomization.
- Partial response (PR) or stable disease (SD) to platinum-based doublet chemotherapy with durvalumab or atezolizumab based on restaging (positron emission tomography [PET]/computed tomography [CT] or CT or magnetic resonance imaging [MRI]).
- Ability to undergo radiotherapy at a total dose of 45 Gy in 15 daily fractions of 3 Gy to the chest area and a total dose of 24 Gy administered in single fractions every 2-3 days of 8 Gy to the metastatic lesions.
Key exclusion criteria (9 listed)
- Age under 18 years old.
- Premenopausal women who do not accept the need for effective contraception during radiotherapy and/or chemotherapy/immunotherapy.
- Individuals excluded from participation in a medical experiment based on Article 23A(1) of the Act on the Profession of Physician and Pharmacist.
- Coexistence of other uncontrolled malignant neoplasms.
- Contraindications to the use of atezolizumab or durvalumab as specified in the SmPC.
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 |
|---|---|---|
| Palliative RadiotherapyStandard treatment with added consolidative radiotherapy to the chest area and possibly metastatic lesions (if indicated) in doses and for palliative indications (total dose of 30 Gy in 10 daily doses of 3 Gy each). | Radiation | Standard Treatment with Palliative Radiotherapy |
| Radical/Ablative RadiotherapyStandard treatment with added radical/ablative radiotherapy (total dose of 45 Gy in 15 daily fractions of 3 Gy to the chest area and total dose of 24 Gy administered in single fractions of 8 Gy every 2-3 days to the metastatic lesions) to the chest area and all metastatic lesions. | Radiation | Standard Treatment with Radical/Ablative Radiotherapy |
Primary outcome
Progression-free survival (PFS) according to RECIST 1.1 imaging criteria or patient death.
Time frame: 12 months after last patient entry
The assessment of the impact of consolidative (radical/palliative) radiotherapy on residual post-chemoimmunotherapy (during immunotherapy) lesions on progression-free survival (PFS).
5 secondary outcomes
Overall survival.
Time frame: At the end of the study (an average of 1 year after last patient entry).
Treatment toxicity (incidence of Grade 3 toxicity according to CTCAE v.5).
Time frame: At the end of the study (an average of 1 year after last patient entry).
Site of progression (primary lesions [present at baseline]/new lesions).
Time frame: At the end of the study (an average of 1 year after last patient entry).
Objective response rate (ORR).
Time frame: At the end of the study (an average of 1 year after last patient entry).
Response rate in nonirradiated lesions.
Time frame: At the end of the study (an average of 1 year after last patient entry).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 28642008Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125. doi: 10.1016/S1470-2045(17)30318-2. Epub 2017 Jun 20.
- Background: PubMed 30280641Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
- Background: PubMed 25230595Slotman BJ, van Tinteren H, Praag JO, Knegjens JL, El Sharouni SY, Hatton M, Keijser A, Faivre-Finn C, Senan S. Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial. Lancet. 2015 Jan 3;385(9962):36-42. doi: 10.1016/S0140-6736(14)61085-0. Epub 2014 Sep 14.
- Background: PubMed 33285097Goldman JW, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Garassino MC, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Thiyagarajah P, Jiang H, Paz-Ares L; CASPIAN investigators. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):51-65. doi: 10.1016/S1470-2045(20)30539-8. Epub 2020 Dec 4.
- Background: PubMed 28648948Gore EM, Hu C, Sun AY, Grimm DF, Ramalingam SS, Dunlap NE, Higgins KA, Werner-Wasik M, Allen AM, Iyengar P, Videtic GMM, Hales RK, McGarry RC, Urbanic JJ, Pu AT, Johnstone CA, Stieber VW, Paulus R, Bradley JD. Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extracranial Irradiation for Extensive-Disease Small Cell Lung Cancer (ED SCLC): NRG Oncology RTOG 0937. J Thorac Oncol. 2017 Oct;12(10):1561-1570. doi: 10.1016/j.jtho.2017.06.015. Epub 2017 Jun 23.
- Background: PubMed 34919882Timmerman R. A Story of Hypofractionation and the Table on the Wall. Int J Radiat Oncol Biol Phys. 2022 Jan 1;112(1):4-21. doi: 10.1016/j.ijrobp.2021.09.027. No abstract available.
- Background: PubMed 33261056Herbreteau G, Langlais A, Greillier L, Audigier-Valette C, Uwer L, Hureaux J, Moro-Sibilot D, Guisier F, Carmier D, Madelaine J, Otto J, Souquet PJ, Gounant V, Merle P, Molinier O, Renault A, Rabeau A, Morin F, Denis MG, Pujol JL. Circulating Tumor DNA as a Prognostic Determinant in Small Cell Lung Cancer Patients Receiving Atezolizumab. J Clin Med. 2020 Nov 27;9(12):3861. doi: 10.3390/jcm9123861.
- Background: PubMed 6354290Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.
- Derived from this study: PubMed 39856583Kuncman L, Fijuth J, Tworek D, Sierko E, Cisek P, Maslowski M, Lisik-Habib M, Orzechowska M, Galwas-Kliber K, Antczak A, Chmielewska I, Ziolkowska B, Kurczewska-Michalak M, Kuznicki W, Jedrzejczak N, Ranoszek K, Bilski M. Radiotherapy(R) Integration(I) Strategy for Small(S)-Cell Lung Cancer in Extensive(E) Stage (RISE) with up to 10 metastases- a study protocol of a randomized phase II trial. BMC Cancer. 2025 Jan 24;25(1):142. doi: 10.1186/s12885-025-13552-y.
- Individual participant dataSharing planned: No
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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.
Łukasz Kuncman, PhD principal investigator
Department of Radiotherapy, Copernicus Memoriał Hospital in Łódź, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Radiotherapy and Radical/Ablative Radiotherapy in people with Small Cell Lung Carcinoma, run by Copernicus Memorial Hospital at 2 sites in Poland.
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 12 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Łukasz Kuncman, PhD (+4842 689 55 55, lm.kuncman@kopernik.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) according to RECIST 1.1 imaging criteria or patient death. (time frame: 12 months after last patient entry). 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 NCT06529081, which also lists 9 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 28 Aug 2025.