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)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (2 UK sites)
University College London Hospital (UCLH)
London, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Christie NHS foundation trust
Manchester, United Kingdom
How to Get in Touch
Dorte Winter
Sponsor contactCONTACT
Toke Hansen, PhD
Sponsor contactCONTACT
