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Hypofractionated Definitive Chemoradiotherapy for Oesophageal Cancer (HYROC)

2 juni 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Nederländerna
      • Amsterdam, Nederländerna
      • Apeldoorn, Nederländerna
        • Har inte rekryterat ännu
        • Gelre Ziekenhuizen
        • Kontakt:
        • Huvudutredare:
          • Karel Eechoute
      • Apeldoorn, Nederländerna
        • Har inte rekryterat ännu
        • Radiotherapiegroep
        • Kontakt:
        • Huvudutredare:
          • Paul M. Jeene
      • Groningen, Nederländerna
        • Rekrytering
        • UMCG
        • Kontakt:
        • Huvudutredare:
          • Christina T. Muijs
      • Heerlen, Nederländerna
        • Har inte rekryterat ännu
        • Zuyderland Medisch Centrum
        • Kontakt:
        • Huvudutredare:
          • Fabienne Warmerdam
      • Maastricht, Nederländerna
        • Har inte rekryterat ännu
        • Maastro
        • Kontakt:
        • Huvudutredare:
          • Maaike Berbée
      • Nijmegen, Nederländerna
        • Har inte rekryterat ännu
        • Radboud UMC
        • Kontakt:
        • Huvudutredare:
          • Heidi Rütten

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Hypofractionated definitive chemoradiotherapy
Participants receive 20 fractions of 2.4 Gy with concurrent 6 cycles of carboplatin and paclitaxel in 4 weeks.
Strålning: Hypofractionation
20 fractions of 2.4 Gy
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of patients who complete all 20 fractions of radiotherapy and receive all 6 cycles of concurrent chemotherapy.
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence and severity of grade ≥4 RIL, and absolute lymphocyte count nadirs.
Tidsram: 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.
Tidsram: 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.
Tidsram: Immediately after the treatment.
Immediately after the treatment.

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence and severity of treatment-related adverse events.
Tidsram: 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).
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

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

Samarbetspartners

University Medical Center Groningen

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 april 2026

Primärt slutförande (Beräknad)

1 april 2028

Avslutad studie (Beräknad)

1 juli 2028

Studieregistreringsdatum

Först inskickad

13 april 2026

Först inskickad som uppfyllde QC-kriterierna

2 juni 2026

Första postat (Faktisk)

8 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NL-010499

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

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