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Looking for participantsPhase3

PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy

Sponsor: University of Aarhus

NCT ID: NCT05055648

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Photon Radiotherapy (radiation), Proton Radiotherapy (radiation)
How long the study runs
Study runs about 127 months (dates as stated)
About the drug or intervention
Photon Radiotherapy — radiation: nCXT consists of weekly carboplatin and paclitaxel for 5 weeks, following the CROSS trial. · Proton Radiotherapy — radiation: nCPT consists of weekly carboplatin and paclitaxel for 5 weeks, following the CROSS trial.
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by the University of Aarhus, compares two types of radiotherapy — proton therapy and standard X-ray (photon) therapy — for people with cancer of the food pipe (oesophagus) or where it joins the stomach. Everyone also has chemotherapy and surgery, and the researchers look at side effects.

Who can take part

  • Adults aged 18 or over with a confirmed diagnosis of squamous cell carcinoma or adenocarcinoma of the oesophagus or gastro-oesophageal junction
  • Cancer that has not spread to other parts of the body, staged using a PET/CT scan
  • Well enough for treatment (performance status WHO 2 or better) with satisfactory blood, liver and kidney test results
  • A medical team decision that the patient is fit for chemotherapy plus radiotherapy followed by surgery (through the chest or keyhole, or a mix)
  • Able to follow the study plan and attend follow-up visits
  • Some people with other low-risk cancers treated successfully may still join
  • People who can become pregnant must have a negative pregnancy test and use reliable contraception during treatment and for one month after

Who may not be able to

  • Previous radiotherapy, chemotherapy or surgery for cancer in the oesophagus or stomach area (some very early removal procedures are allowed)
  • Tumour less than 3 cm from the upper swallowing muscle (sphincter)
  • Surgery planned through the abdomen only (transhiatal resection)
  • Another cancer in the past 5 years, unless fully treated at least 5 years before joining
  • Serious uncontrolled illness, such as significant heart, lung, liver, kidney or inflammatory bowel disease
  • Nerve damage (neuropathy) in the hands or feet causing symptoms worse than mild
  • Any other serious illness that the study doctor believes makes taking part unwise
  • Unable to understand the study information or follow instructions
  • A stent in the food pipe within the area being treated

What taking part involves

  • • Chemotherapy combined with radiotherapy before surgery — using either proton beam therapy or standard photon (X-ray) radiotherapy
  • • Surgery to remove the cancer (oesophagectomy or gastrectomy), which may be open, keyhole, or a combination
  • • Follow-up visits as part of the study

Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and exactly what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
396
Started
2022-05-01
Last checked
2024-12

Plain English Summary

What is this study?

  • • Testing a new treatment for esophageal cancer
  • • Phase3 - 396 participants
  • • The PROTECT trial will test the hypothesis that proton (PT) -enabled radiation dose reductions to sensitive, normal tissues will result in lower rates of treatment-related pulmonary complications in esophageal cancer compared to standard photon therapy (XT)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with esophageal cancer

Where?

  • • London - University College London Hospital (UCLH)
  • • Manchester - The Christie NHS foundation trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The PROTECT trial will test the hypothesis that proton (PT) -enabled radiation dose reductions to sensitive, normal tissues will result in lower rates of treatment-related pulmonary complications in esophageal cancer compared to standard photon therapy (XT).

More detail

PROTECT is a unblinded international multicenter randomized phase III study for patients with operable EC or EGC receiving nCXT (standard of care) or nCPT (intervention). The study will be open-label for the patient and the treating physician. The radiation dose is either 41.4 Gy in 23 fractions, five fractions per week or 50.4 Gy in 28 fractions, five fractions per week. Prior to trial opening, each proton center will determine a single dose regimen for all patients treated in that specific proton center and its assigned photon centers. The protocol prescribes that all referring centers will use the same chemotherapy regimen, which is weekly carboplatin (AUC 2), and paclitaxel (50 mg/m2), five cycles, irrespective of choice of dose regimen. Chemotherapy is a non-investigational drug. Prior to referral to any proton therapy center, patients will be randomed (1:1) to either nCXT or nCPT. Only patients randomized to the PT arm will be referred to a PT center. Randomization will be performed centrally using an online 24-hour web-based system maintained by the Clinical Trial Office at Aarhus University Hospital, ensuring allocation concealment to the clinical investigators. The method of randomization will be stratified permuted blocks of size 4 and 6 (selected randomly) with the following strata: * Histopathology (non-squamous vs squamous cell carcinoma) * Planned surgical technique (open versus minimal invasive/robotic or hybrid) * Proton center and sites assigned to this center (which will deliver the nCXT)

Esophageal CancerRadiotherapySide EffectProton Therapy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

present a negative

Treatment history

Treatments you must NOT have had:

  • ✗ malignancies

What the study is looking for

  • ✓FDG PET/CT performed.
  • ✓Tumor stage according to TNM (8th edition): cT1-4a and/or cN+, cM0.
  • ✓Age ≥18 years.
  • ✓Performance status WHO ≤2.
  • ✓MDT decision on suitability to undergo curatively intended nCXT or nCPT followed by surgery.

Who cannot take part

  • ✗Patients who meet one or more of the following exclusion criteria cannot be included in the study:
  • ✗Prior thoracic XT or PT, drug treatment or surgical resection in the esophageal/gastric region (previous EMR or ESD is...
  • ✗Tumor \< 3 cm from oropharyngeal sphincter.
  • ✗Planned transhiatal resection
  • ✗Patients with other previous malignancies are excluded unless a complete remission or complete resection was...
See the full criteria
Inclusion Criteria: * Patients with histologically verified squamous cell carcinoma or adenocarcinoma (including signet cell carcinoma and large cell carcinoma, not further specified) of the esophagus (E) or gastro-esophageal junction (GEJ). * FDG PET/CT performed. * Tumor stage according to TNM (8th edition): cT1-4a and/or cN+, cM0. * Age ≥18 years. * Performance status WHO ≤2. * Adequate laboratory findings: hematological: hemoglobin \> 90 g/L, absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 75 x 109/L hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), ALAT ≤ 3 x ULN renal: creatinine ≤ 1.5 x ULN, GFR (may be calculated) \> 30 ml/min * MDT decision on suitability to undergo curatively intended nCXT or nCPT followed by surgery. * Planned transthoracic esophagectomy or gastrectomy being open, minimally invasive of combination of both. * Ability to adhere to procedures for study and follow-up. * Patients with low risk cancers with a life expectancy above 5 years (e.g. low risk prostate cancer) are allowed in the study. Adequately treated diagnoses such as cervix uteri carcinoma in situ, in situ urothelial carcinoma or localized non-melanoma skin cancer are allowed, regardless of time of diagnosis. * Patients of childbearing potential: pregnancy prevention according to the standards of each country. Patients of childbearing potential must present a negative pregnancy test. Patients and their partners must use effective contraception. Patients of childbearing potential included in the study must use oral contraceptives, intrauterine devices, depot injection of progestin subdermal implantation, a hormonal vaginal ring, or transdermal patch during the study treatment and one month after. Exclusion Criteria: Patients who meet one or more of the following exclusion criteria cannot be included in the study: * Prior thoracic XT or PT, chemotherapy or surgical resection in the esophageal/gastric region (previous EMR or ESD is allowed). * Tumor \< 3 cm from oropharyngeal sphincter. * Planned transhiatal resection * Patients with other previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry. * Any unstable systemic disease (including clinically significant lung and cardiovascular disease, unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart, severe hepatic, renal or metabolic disease or active inflammatory bowel disease). * Symptomatic peripheral neuropathy greater than grade 1 (scored according to CTCAE v5.0). * Any other serious or uncontrolled illness, which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial. * Unable to understand and digest study patient information or comply with study treatment and safety instructions. * Gastro-esophageal stent within the irradiated volume.

Where Is This Study? (2 UK sites)

University College London Hospital (UCLH)

London, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

The Christie NHS foundation trust

Manchester, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Ganesh Radhakrishnag.radhakrishna@nhs.net

How to Get in Touch

Dorte Winter

Sponsor contact

CONTACT

+45 78456442 dorte.skriver.winther@auh.rm.dk

Toke Hansen, PhD

Sponsor contact

CONTACT

+45 78456442 tokeha@rm.dk
Data sourced from ClinicalTrials.gov · Last verified: 2024-12