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Hypofractionated Definitive Chemoradiotherapy for Oesophageal Cancer (HYROC)

2. juni 2026 oppdatert av: Peter S.N. van Rossum, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

HYpofractionated Definitive chemoRadiotherapy for Oesophageal Cancer (HYROC): a Multicenter Phase II Feasibility Study

The goal of this clinical trial is to learn if hypofractionation of definitive chemoradiotherapy can treat patients with locally advanced esophageal cancer. The main question it aims to answer is if this treatment is feasible and safe. We also want to investigate the toxicity, in particular the radiation-induced lymphopenia.

Normally, definitive chemoradiotherapy for patients with locally advanced esophageal cancer consist of 28 fractions of 1.8 Gy with concurrent 6 cycles of carboplatin and paclitaxel in 5.5 weeks. In this study, participants will receive 20 fractions of 2.4 Gy with concurrent 6 cycles of carboplatin and paclitaxel in 4 weeks. The follow-up will be conform standard-of-care.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Nederland
      • Amsterdam, Nederland
      • Apeldoorn, Nederland
        • Har ikke rekruttert ennå
        • Gelre Ziekenhuizen
        • Ta kontakt med:
        • Hovedetterforsker:
          • Karel Eechoute
      • Apeldoorn, Nederland
        • Har ikke rekruttert ennå
        • Radiotherapiegroep
        • Ta kontakt med:
        • Hovedetterforsker:
          • Paul M. Jeene
      • Groningen, Nederland
        • Rekruttering
        • UMCG
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christina T. Muijs
      • Heerlen, Nederland
        • Har ikke rekruttert ennå
        • Zuyderland Medisch Centrum
        • Ta kontakt med:
        • Hovedetterforsker:
          • Fabienne Warmerdam
      • Maastricht, Nederland
        • Har ikke rekruttert ennå
        • Maastro
        • Ta kontakt med:
        • Hovedetterforsker:
          • Maaike Berbée
      • Nijmegen, Nederland
        • Har ikke rekruttert ennå
        • Radboud UMC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Heidi Rütten

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age ≥18 years.
  • Histologically confirmed oesophageal or GOJ carcinoma (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, large cell carcinoma or undifferentiated carcinoma).
  • An oesophageal tumour location can involve the proximal, middle and/or distal third of the oesophagus.
  • If the tumour extends below the GOJ into the cardia, the bulk of the tumour must involve the oesophagus or GOJ (i.e. Siewert type I or II). The tumour should not extend more than 5 cm into the stomach.
  • Clinical stage cT1N1-3M0 or cT2-4aN0-3M0, using the Tumour-Node-Metastasis classification system (TNM, 8th edition), deemed suitable for definitive CRT with curative intent.
  • No evidence of distant metastases (M0), as confirmed by standard staging procedures including Fluorine-18 Fluorodeoxyglucose (18F-FDG) PET/CT.
  • World Health Organization (WHO) performance status 0-2.

  • Adequate hematologic, renal, and hepatic function:

    • Platelet count ≥100 × 10⁹/L
    • Absolute neutrophil count ≥1.5 × 10⁹/L
    • Glomerular filtration rate ≥50 mL/min
    • Total bilirubin ≤1.5 × upper normal limit
  • Written informed consent obtained before any study-specific procedures.
  • Able to comply with study procedures and scheduled follow-up.

Exclusion Criteria:

  • High grade dysplasia without histological evidence of invasive carcinoma.
  • Presence of distant metastases (M1).
  • Patients with pathological lymph nodes at both supraclavicular and celiac trunk level.
  • Prior thoracic or upper abdominal radiotherapy that would preclude safe delivery of the planned radiotherapy dose.
  • Prior chemotherapy for oesophageal or gastric cancer.
  • Presence of an oesophageal stent.
  • Active uncontrolled infection.
  • Clinically significant comorbidities that would preclude safe administration of CRT (e.g. severe pulmonary, cardiac, or hepatic impairment).
  • Pregnancy or breastfeeding.
  • Known hypersensitivity to paclitaxel, carboplatin, or any of their excipients.
  • History of malignancies, with the exception of basal cell carcinoma of the skin, ductal carcinoma in situ of breast, cervical intraepithelial neoplasia of uterine cervix, or other malignancies that do not interfere with the prognosis of oesophageal cancer.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Hypofractionated definitive chemoradiotherapy
Participants receive 20 fractions of 2.4 Gy with concurrent 6 cycles of carboplatin and paclitaxel in 4 weeks.
Stråling: Hypofractionation
20 fractions of 2.4 Gy
Legemiddel: carboplatin + paclitaxel (CP)
6 cycles of carboplatin (AUC 2) and paclitaxel (50 mg/m2) given every 4-5 days, 6 cycles in total in 4 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of patients who complete all 20 fractions of radiotherapy and receive all 6 cycles of concurrent chemotherapy.
Tidsramme: Immediately after the treatment.
Feasibility, defined as ≥50% of patients completing all 20 radiotherapy fractions and all 6 planned chemotherapy cycles.
Immediately after the treatment.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence and severity of grade ≥4 RIL, and absolute lymphocyte count nadirs.
Tidsramme: Baseline, after first week of treatment, after second week of treatment, after third week of treatment, after fourth week of treatment, 3 months after the treatment.
The RIL will be scored according to CTCAE v5.0.
Baseline, after first week of treatment, after second week of treatment, after third week of treatment, after fourth week of treatment, 3 months after the treatment.
Incidence of grade ≥3 acute toxicity.
Tidsramme: Baseline, after first week of treatment, after second week of treatment, after third week of treatment, after fourth week of treatment, 3 months after the treatment.
The acute toxicity will be scored according to CTCAE v5.0.
Baseline, after first week of treatment, after second week of treatment, after third week of treatment, after fourth week of treatment, 3 months after the treatment.
Proportion of patients who complete at least 19 of 20 radiotherapy fractions and at least 5 out of 6 planned chemotherapy cycles.
Tidsramme: Immediately after the treatment.
Immediately after the treatment.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence and severity of treatment-related adverse events.
Tidsramme: After first week of treatment, after second week of treatment, after third week of treatment, after fourth week of treatment, 3 months after treatment, 1 year, 2 years, 3 years, 4 years, 5 years
The adverse events will be scored according to CTCAE v5.0.
After first week of treatment, after second week of treatment, after third week of treatment, after fourth week of treatment, 3 months after treatment, 1 year, 2 years, 3 years, 4 years, 5 years
Progression Free Survival (PFS) and Overall Survival (OS).
Tidsramme: 1 year, 2 years, 3 years, 4 years, 5 years
1 year, 2 years, 3 years, 4 years, 5 years
Patient-reported quality of life during and after the treatment.
Tidsramme: Baseline, 3 months after treatment, 1 year, 2 years, 3 years, 4 years, 5 years
Assessed using validated questionnaires collected through the POCOP national prospective cohort.
Baseline, 3 months after treatment, 1 year, 2 years, 3 years, 4 years, 5 years
Costs associated with the treatment.
Tidsramme: 3 months after treatment.
3 months after treatment.
Feasibility and clinical outcomes of the treatment compared to a propensity score-matched standard-of-care cohort.
Tidsramme: 3 months after treatment, 1 year, 2 years, 3 years, 4 years, 5 years
A propensity score-matched cohort will be assembled using data from the University Medical Center Groningen (UMCG) prospective registry for toxicity comparison, and the Netherlands Cancer Registry (NCR) for OS comparison.
3 months after treatment, 1 year, 2 years, 3 years, 4 years, 5 years
1. Association of dosimetric parameters of the lungs and heart with radiation-induced lymphopenia. 2. Association of target volume size with radiation-induced lymphopenia.
Tidsramme: 1 month after treatment
  1. Associations between predefined lung and heart dose-volume parameters and radiation-induced lymphopenia will be assessed. Dose-volume parameters will include V5Gy, V10Gy, V15Gy, V20Gy, V25Gy, V30Gy, V35Gy, V40Gy, V45Gy, and mean dose. Radiation-induced lymphopenia will be assessed as grade ≥3 at any time during treatment, grade ≥4 at any time during treatment, and grade ≥3 in week 3 of treatment. Associations will be reported separately for each parameter and definition as odds ratios with 95% confidence intervals.
  2. Associations between the predefined target volume parameter 'planning target volume' (PTV) measured in cubic centimeters, and radiation-induced lymphopenia will be assessed using the same definitions as described above. Associations will be reported separately for PTV and radiation-induced lymphopenia definition as odds ratio (per 100 cm3) with 95% confidence interval.
1 month after treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Samarbeidspartnere

University Medical Center Groningen

Etterforskere

  • Hovedetterforsker: Peter S.N. van Rossum, Amsterdam University Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. april 2026

Primær fullføring (Antatt)

1. april 2028

Studiet fullført (Antatt)

1. juli 2028

Datoer for studieregistrering

Først innsendt

13. april 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NL-010499

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Due to the sensitivity of the collected data, the data itself cannot be published or shared without restrictions. We will consult the Data Protection Officer and Research Data Management regarding potential for sharing the data, and Legal Research Support regarding setting up conditions for reuse.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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