Informations générales (source: ClinicalTrials.gov)
PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy (PROTECT) a Multicenter International Randomized Phase III Study of Neoadjuvant Proton Versus Photon Chemoradiotherapy in Locally Advanced Esophageal Cancer (PROTECT)
Interventional
Phase 3
University of Aarhus (Voir sur ClinicalTrials)
mai 2022
décembre 2032
05 avril 2025
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Gilles Crehange | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne (CAL) - Nice - France | Jérôme Doyen | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard (CLB) - Lyon - France | Laurie Bissuel | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
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.