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Small Cell Lung CarcinomaPhase 3ESCALADORNCT07015892

Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial

A Phase 3 study testing Thoracic Radiotherapy 45 Gy BID, Thoracic Radiotherapy 60 Gy BID and Thoracic Radiotherapy SIB 45-54 Gy BID in people with Small Cell Lung Carcinoma, run by Instituto de Investigación Biomédica de Salamanca at 13 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase III clinical trial that aims to evaluate whether increasing the dose of radiotherapy given twice a day can improve treatment outcomes in patients with localized small cell lung cancer (SCLC). 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?
Thoracic Radiotherapy 45 Gy BID, Thoracic Radiotherapy 60 Gy BID and Thoracic Radiotherapy SIB 45-54 Gy BID
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
13 sitesSpain
Study dates
1 Mar 2026to 31 Dec 2028
Phase
Phase 3
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

  • Histologically confirmed diagnosis of small cell lung cancer (SCLC)
  • Limited-stage disease (Stage I-III; any T, any N, M0), eligible for definitive radiotherapy
  • Measurable disease according to RECIST 1.1
  • Age ≥18 years
  • ECOG performance status 0-2
  • No prior thoracic radiotherapy
Show all 10Show fewer
  • Signed informed consent
  • Adequate hematologic function: WBC ≥3.0×10⁹/L, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L
  • Adequate liver and renal function: total bilirubin ≤1.5×ULN, AST/ALT ≤1.5×ULN, creatinine normal or CrCl ≥60 mL/min
  • Pulmonary function: FEV1 >1 L or >30% predicted; DLCO >30% predicted

Who cannot join

  • Prior surgery or radiotherapy for any lung cancer (SCLC or NSCLC)
  • Presence of malignant cells in pleural or pericardial effusion
  • Serious uncontrolled systemic disorders (e.g., active infection, unstable cardiovascular disease)
  • Medical, psychological, or social conditions that could interfere with compliance
  • Active malignancy other than SCLC (except localized prostate/breast cancer or basal cell carcinoma)
  • Refusal or inability to sign informed consent

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Iñigo San Miguel Arregui, MD PhD contact

+34 923291600

isanm@saludcastillayleon.es

Cristina Cigarral García, MD contact

+34 923291600

ccigarral@usal.es

13 sites in 1 country

Spain13 sites, 13 recruiting

  • Hospital Universitario de Torrecardenas

    Almería

    Manuel Luna, PhD, +34 950 016 000, luna.me92@gmail.com

    Not yet recruiting

  • Hospital Universitario de Cruces

    Barakaldo

    Jon Cacicedo, PhD, +34 946 00 60 00, jon.cacicedofernandezbobadilla@osakidetza.eus

    Not yet recruiting

  • Instituto Catalán de Oncología

    Girona

    Ester Oliva, PhD, +34 972 22 51 58, eoliva@iconcologia.net

    Not yet recruiting

  • Hospital Dr. Negrin

    Las Palmas de Gran Canaria

    Marta Lloret, PhD, +34 928 45 00 00, mllosae@hotmail.com

    Not yet recruiting

  • Hospital Gregorio Marañon

    Madrid

    Marina Santos, PhD, +34 915 86 80 00, marinasantos15@hotmail.com

    Not yet recruiting

  • Hospital Ramon y Cajal

    Madrid

    Margarita Martín, PhD, +34 913 36 80 00, oncomarga@gmail.com

    Recruiting

  • Hospital Universitario Virgen de Arrixaca

    Murcia

    Francisco Javier López, PhD, +34 968 36 95 00, flopezsoler@hotmail.com

    Not yet recruiting

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, Salamanca, 37007

    Iñigo San Miguel Arregui, MD PhD, +34 923291600, isanm@saludcastillayleon.es

    Cristina Cigarral García, MD

    Recruiting

  • Hospital Marques de Valdecilla

    Santander

    Ivan Díaz de Cerio, PhD, +34 942 20 25 20, ivancerio@hotmail.com

    Not yet recruiting

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

    Begoña Taboada, PhD, +34 981 95 00 00, btabval@gmail.com

    Not yet recruiting

  • Genesis Care

    Seville

    Jose Antonio González, PhD, +34 954 46 70 53, sevilla@genesiscare.es

    Not yet recruiting

  • Hospital Universitario Virgen del Rocio

    Seville

    Jose Luis Lopez Guerra, PhD, +34 955 01 20 00, chanodetriana@yahoo.es

    Recruiting

  • Hospital La Fe

    Valencia

    Rodolfo Chicas, PhD, +34 961 24 40 00, rchicas@ufm.edu

    Not yet recruiting

Other trials in Spain

About this study

Official title: Phase III Randomized Clinical Trial to Evaluate the Efficacy and Safety of Twice-Daily Hyperfractionated Dose-Escalated Thoracic Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer (ESCALADOR Study)

This is a phase III clinical trial that aims to evaluate whether increasing the dose of radiotherapy given twice a day can improve treatment outcomes in patients with localized small cell lung cancer (SCLC). All patients will receive standard chemotherapy with cisplatin and etoposide and will be randomly assigned to one of three radiotherapy regimens.

The main objective is to determine whether this intensified radiotherapy improves progression-free survival and overall survival. The study will also compare two different dose escalation strategies and assess treatment side effects and patients' quality of life.

This research may help identify a more effective treatment approach for patients with limited-stage SCLC and could contribute to improving long-term survival in this aggressive type of cancer

Read the detailed description

This is a phase III, prospective, randomized, multicenter trial designed to evaluate whether a dose escalation strategy using twice-daily hyperfractionated thoracic radiotherapy can improve outcomes in patients with limited-stage small cell lung cancer (LS-SCLC).

Patients will be randomly assigned to one of three treatment arms: (A) standard-dose radiotherapy (45 Gy in 30 fractions BID), (B) escalated-dose radiotherapy (60 Gy in 40 fractions BID), or (C) standard-dose with a simultaneous integrated boost (45-54 Gy BID). All patients will receive concurrent chemotherapy with cisplatin and etoposide.

The study aims to determine if intensified radiotherapy increases progression-free survival (PFS) and overall survival (OS). Secondary objectives include comparing toxicity profiles, quality of life (using EORTC QLQ-C30 and LC13/LC29), and exploratory analyses of circulating biomarkers.

LS-SCLC has high recurrence rates despite aggressive treatment. Although BID thoracic radiotherapy (TRT) of 45 Gy is considered standard, new evidence suggests that higher doses may further improve survival without increasing toxicity. Modern radiotherapy techniques and improved imaging (e.g., PET-CT) allow more accurate targeting and potential dose escalation.

The study plans to enroll 300 patients over 36 months across 10-15 Spanish centers, coordinated by the Instituto de Investigación Biomédica de Salamanca (IBSAL) and supported by SEOR-GOECP. An interim analysis will be conducted at year 1 and year 3, with a final analysis at 5 years. Data will be collected via REDCap and follow FAIR principles. The protocol has been approved by the Salamanca Research Ethics Committee.

This trial seeks to define whether a higher radiotherapy dose improves long-term outcomes in LS-SCLC and to explore how biomarker data might inform future personalized treatments.

Being tested
Thoracic Radiotherapy 45 Gy BID, Thoracic Radiotherapy 60 Gy BID, Thoracic Radiotherapy SIB 45-54 Gy BID
Keywords
Radiotherapy, Chemoradiotherapy, Dose-Response Relationship, Radiation
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.

  • Thoracic Radiotherapy 45 Gy BIDRadiation

    45 Gy delivered in 30 fractions of 1.5 Gy twice daily over three weeks, with 95% of the planning target volume (PTV) receiving at least 95% of the prescribed dose.

  • Thoracic Radiotherapy 60 Gy BIDRadiation

    60 Gy delivered in 40 fractions of 1.5 Gy BID. A minimum dose of 54 Gy will be accepted if organ-at-risk tolerance is exceeded.

  • Thoracic Radiotherapy SIB 45-54 Gy BIDRadiation

    45 Gy in 30 fractions (1.5 Gy BID) to PTV and 54 Gy in 30 fractions (1.8 Gy BID) to high-risk CTV. Both delivered simultaneously using 3D conformal planning.

Study groups in NCT07015892
Study groupRoleWhat they receive
Standard Radiotherapy Arm (45 Gy BID)Active comparatorPatients in this group will receive concurrent chemoradiotherapy consisting of cisplatin and etoposide with standard-dose thoracic radiotherapy: 45 Gy administered in 30 fractions of 1.5 Gy twice daily (BID).
Receives: Radiation: Thoracic Radiotherapy 45 Gy BID
Escalated Dose Radiotherapy Arm (60 Gy BID)ExperimentalPatients in this group will receive the same chemotherapy as Arm 1, combined with an escalated thoracic radiotherapy dose: 60 Gy delivered in 40 fractions of 1.5 Gy twice daily (BID). Dose may be reduced to 54 Gy if organs at risk exceed tolerance.
Receives: Radiation: Thoracic Radiotherapy 60 Gy BID
Simultaneous Integrated Boost Radiotherapy Arm (45-54 Gy BID)ExperimentalPatients in this group will receive the same chemotherapy as in other arms, with thoracic radiotherapy delivered as a simultaneous integrated boost (SIB): 45 Gy to the general target volume and 54 Gy to the high-risk clinical target volume (CTV) in 30 fractions BID.
Receives: Radiation: Thoracic Radiotherapy SIB 45-54 Gy BID

What is being measured

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

  1. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) is defined as the time from randomization to documented disease progression based on RECIST 1.1 criteria or death from any cause. Patients will be evaluated at baseline, every 3 months for the first 2 years, then every 6 months up to year 5 using imaging and clinical assessment.

    Measured: From date of randomization until disease progression or death, whichever occurs first, assessed up to 5 years

Secondary outcomes (6)

  1. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from randomization to death from any cause. Patients will be followed longitudinally through scheduled clinical visits and survival status checks

    Measured: From date of randomization until death from any cause, assessed up to 5 years

  2. Incidence of Acute and Late Toxicities (per CTCAE v4.0)

    Toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Both acute and late toxicities (e.g., esophagitis, pneumonitis, hematologic toxicity) will be recorded during treatment and follow-up.

    Measured: From treatment initiation through 5-year follow-up

  3. Quality of Life Assessment (EORTC QLQ-C30)

    Quality of life will be measured using the EORTC QLQ-C30. Changes in scores over time will be analyzed to evaluate treatment impact on physical, emotional, and functional well-being. The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a validated instrument designed to assess the quality of life of cancer patients. It includes 30 items organized into multi-item scales and single-item measures, covering a range of functional domains, symptoms, and overall health status. All items are scored on a 1 to 4 Likert scale (1 = "Not at all" to 4 = "Very much"), except for the two items of the global health status/QoL scale, which are scored from 1 to 7 (1 = "Very poor" to 7 = "Excellent").

    A high score on a functional scale reflects better functioning. A high score on a symptom scale reflects worse symptom severity. A high global health/QoL score indicates overall good health and quality of life as perceived by the patient.

    Measured: Baseline, 3 months, 6 months, 12 months, and annually up to 5 years

  4. Quality of life Assesment (LC13)

    Quality of life will be measured using lung cancer-specific module LC13. Changes in scores over time will be analyzed to evaluate treatment impact on physical, emotional, and functional well-being. The EORTC QLQ-LC13 is a lung cancer-specific module designed to be used in conjunction with the EORTC QLQ-C30. It focuses on lung cancer-related symptoms and treatment side effects, particularly from chemotherapy and radiotherapy. Just like with the QLQ-C30, raw scores are linearly transformed to a 0-100 scale for each item or symptom scale. Higher scores always reflect worse symptoms or more severe treatment-related side effects. A change of ≥10 points is typically considered clinically meaningful.

    Combined with the QLQ-C30, the LC13 enhances sensitivity to lung-specific disease burden and treatment toxicity.

    Measured: Baseline, 3 months, 6 months, 12 months, and annually up to 5 years

  5. Quality of Life Assesment (LC29)

    Quality of life will be measured using the lung cancer-specific module LC29. Changes in scores over time will be analyzed to evaluate treatment impact on physical, emotional, and functional well-being. The EORTC QLQ-LC29 is a lung cancer-specific quality of life questionnaire, that captures a broader and more contemporary range of lung cancer symptoms and treatment-related side effects, especially relevant to newer therapies like immunotherapy and targeted agents. The QLQ-LC29 is designed to be used in conjunction with the EORTC QLQ-C30. All items are scored on a 1-4 Likert scale:

    1. = Not at all
    2. = A little
    3. = Quite a bit
    4. = Very much Scores are linearly transformed to a 0-100 scale. For all LC29 items and scales: Higher scores indicate more severe symptoms or problems.

    LC29 retains some items from LC13 (e.g., cough, dyspnea, pain) but adds new domains (e.g., fear of progression, trouble concentrating). Provides a broader range of symptoms, including psychosocial concerns.

    Measured: Baseline, 3 months, 6 months, 12 months, and annually up to 5 years

  6. Time to First Local or Distant Recurrence

    Time to recurrence will be measured based on clinical and radiological evaluations. Recurrences will be categorized as local (within the irradiated field) or distant (outside the thoracic field).

    Measured: From randomization until first documented recurrence, assessed up to 5 years

Timeline

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

  1. First posted11 Jun 2025
  2. Study start1 Mar 2026
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible patients are randomized in a 1:1:1 ratio to one of three parallel treatment arms. All arms include concurrent chemoradiotherapy with cisplatin and etoposide, but differ in the radiotherapy dose and technique: standard-dose BID radiotherapy (45 Gy), dose-escalated BID radiotherapy (60 Gy), or BID radiotherapy with a simultaneous integrated boost to 54 Gy.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015892
Sponsor's protocol ID
ESCALADOR Study
Other IDs
PI 2024 11 1761
Acronym
ESCALADOR
Status last verified
Mar 2026
First submitted
28 May 2025
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie the results reported in future publications (after de-identification) will be made available upon reasonable request. This includes data related to baseline characteristics, treatment administration, toxicity, tumor response, survival outcomes, and quality of life assessments

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Thoracic Radiotherapy 45 Gy BID, Thoracic Radiotherapy 60 Gy BID and Thoracic Radiotherapy SIB 45-54 Gy BID in people with Small Cell Lung Carcinoma, run by Instituto de Investigación Biomédica de Salamanca at 13 sites 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 10 inclusion and 6 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Iñigo San Miguel Arregui, MD PhD (+34 923291600, isanm@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: From date of randomization until disease progression or death, whichever occurs first, assessed up to 5 years). 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 NCT07015892.

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 31 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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