Locally Advanced Esophageal or GE Junction CancerPhase 2HYROCNCT07632079
Hypofractionated Definitive Chemoradiotherapy for Oesophageal Cancer
A Phase 2 study testing Hypofractionation and carboplatin + paclitaxel (CP) in people with Locally Advanced Esophageal or GE Junction Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 7 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Esophageal or GE Junction Cancer
- What is being tested?
- Hypofractionation and carboplatin + paclitaxel (CP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesNetherlands
- Study dates
- 28 Apr 2026to Jul 2028
- Phase
- Phase 2
- 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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. P.S.N. van Rossum contact
7 sites in 1 country
Netherlands7 sites, 7 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Iris Agterberg, +31 204441571, i.agterberg@amsterdamumc.nl
Dr. P.S.N. van Rossum, +31 204441571, p.s.n.vanrossum@amsterdamumc.nl
- Not yet recruiting
Gelre Ziekenhuizen
Apeldoorn
Dr. K. Eechoute, +31 88 105 3300, k.eechoute@gelre.nl
Karel Eechoute
- Not yet recruiting
Radiotherapiegroep
Apeldoorn
Dr. P.M. Jeene, +31 88 779 0000, p.jeene@radiotherapiegroep.nl
Paul M. Jeene
- Recruiting
UMCG
Groningen
Dr. C.T. Muijs, +31 50 361 6161, c.t.muijs@umcg.nl
Christina T. Muijs
- Not yet recruiting
Zuyderland Medisch Centrum
Heerlen
Dr. F. Warmerdam, +31 88 459 7777, f.warmerdam@zuyderland.nl
Fabienne Warmerdam
- Not yet recruiting
Maastro
Maastricht
Dr. M. Berbée, +31 88 445 5600, maaike.berbee@maastro.nl
Maaike Berbée
- Not yet recruiting
Radboud UMC
Nijmegen
Dr. H. Rütten, +31 24-361 11 1, Heidi.Rutten@radboudumc.nl
Heidi Rütten
About this study
Official title: 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.
- Being tested
- Hypofractionation, carboplatin + paclitaxel (CP)
- Keywords
- Definitive chemoradiotherapy, Hypofractionation, Locally advanced esophageal or GE junction cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypofractionationRadiation
20 fractions of 2.4 Gy
carboplatin + paclitaxel (CP)Drug
6 cycles of carboplatin (AUC 2) and paclitaxel (50 mg/m2) given every 4-5 days, 6 cycles in total in 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated definitive chemoradiotherapy | Experimental | Participants receive 20 fractions of 2.4 Gy with concurrent 6 cycles of carboplatin and paclitaxel in 4 weeks. Receives: Radiation: Hypofractionation; Drug: carboplatin + paclitaxel (CP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who complete all 20 fractions of radiotherapy and receive all 6 cycles of concurrent chemotherapy.
Feasibility, defined as ≥50% of patients completing all 20 radiotherapy fractions and all 6 planned chemotherapy cycles.
Measured: Immediately after the treatment.
Secondary outcomes (3)
Incidence and severity of grade ≥4 RIL, and absolute lymphocyte count nadirs.
The RIL will be scored according to CTCAE v5.0.
Measured: 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.
The acute toxicity will be scored according to CTCAE v5.0.
Measured: 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.
Measured: Immediately after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start28 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Esophageal or GE Junction CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Principal investigator, Peter S.N. van Rossum, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Peter S.N. van Rossum, Principal investigator, Amsterdam University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632079
- Sponsor's protocol ID
- NL-010499
- Acronym
- HYROC
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYpofractionated Definitive chemoRadiotherapy for Oesophageal Cancer (HYROC): a Multicenter Phase II Feasibility Study
- ClinicalTrials.gov ID
- NCT07632079
- Acronym / sponsor ID
- HYROC / NL-010499
- Keywords
- Definitive chemoradiotherapy, Hypofractionation, Locally advanced esophageal or GE junction cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 8 Jun 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated definitive chemoradiotherapy | Experimental | Radiation: Hypofractionation, Drug: carboplatin + paclitaxel (CP)Participants receive 20 fractions of 2.4 Gy with concurrent 6 cycles of carboplatin and paclitaxel in 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Hypofractionation20 fractions of 2.4 Gy | Radiation | Hypofractionated definitive chemoradiotherapy |
| 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. | Drug | Hypofractionated definitive chemoradiotherapy |
Primary outcome
Proportion of patients who complete all 20 fractions of radiotherapy and receive all 6 cycles of concurrent chemotherapy.
Time frame: Immediately after the treatment.
Feasibility, defined as ≥50% of patients completing all 20 radiotherapy fractions and all 6 planned chemotherapy cycles.
3 secondary outcomes
Incidence and severity of grade ≥4 RIL, and absolute lymphocyte count nadirs.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after the treatment.
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 8 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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.
Dr. P.S.N. van Rossum contact
Peter S.N. van Rossum principal investigator
Amsterdam University Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionation and carboplatin + paclitaxel (CP) in people with Locally Advanced Esophageal or GE Junction Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 7 sites in Netherlands.
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 14 inclusion and 11 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Iris Agterberg (+31 204441571, i.agterberg@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who complete all 20 fractions of radiotherapy and receive all 6 cycles of concurrent chemotherapy. (time frame: Immediately after the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2026.