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Compares treatment options for Esophageal Cancer
Official title PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy
ClinicalTrials.gov ID: NCT05055648
What this study is testing
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with histologically verified squamous cell carcinoma or adenocarcinoma (including signet cell carcinoma and large cell carcinoma, not...
- FDG PET/CT performed.
- Tumor stage according to TNM (8th edition): cT1-4a and/or cN+, cM0.
- Age ≥18 years.
- Performance status WHO ≤2.
You likely can't join if
- 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...
- Any unstable systemic disease (including clinically significant lung and cardiovascular disease, unstable angina, New York Heart Association (NYHA)...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
- Aarhus, Denmark
- Lyon, France
- Nice, France
- Paris, France
- Dresden, Germany
- Milan, Italy
- Pavia, Italy
- Trento, Italy
- Groningen, Netherlands
- Maastricht, Netherlands
- Villigen, Switzerland
- Zurich, Switzerland
- London, United Kingdom
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium; Aarhus, Denmark; Lyon, France; Nice, France; Paris, France; Dresden, Germany and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.