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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Catholic University of Leuven
RECRUITING
Leuven
Denmark
Aarhus University Hospital (AUH)
RECRUITING
Aarhus
France
Centre Léon Bérard (CLB)
NOT_YET_RECRUITING
Lyon
Centre Antoine Lacassagne (CAL)
NOT_YET_RECRUITING
Nice
Institut Curie
NOT_YET_RECRUITING
Paris
Germany
Technische Universität Dresden (TUD)
RECRUITING
Dresden
Italy
San Raffaele Hospital
RECRUITING
Milan
Centro Nazionale di Adroterapia Oncologica (CNAO)
RECRUITING
Pavia
Azienda Provinciale Per I Servizi Sanitari (APSS)
RECRUITING
Trento
Netherlands
Academisch Ziekenhuis Groningen (UMCG)
WITHDRAWN
Groningen
Stichting Maastricht Radiation Oncology (MAASTRO)
WITHDRAWN
Maastricht
Switzerland
Paul Scherrer Institute (PSI)
RECRUITING
Villigen
University Hospital Zurich (USZ)
RECRUITING
Zurich
United Kingdom
University College London Hospital (UCLH)
WITHDRAWN
London
The Christie NHS foundation trust
NOT_YET_RECRUITING
Manchester
Contact Information
Primary
Dorte Winter
dorte.skriver.winther@auh.rm.dk
+45 78456442
Backup
Toke Hansen, PhD
tokeha@rm.dk
+45 78456442
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2032-12-01
Participants
Target number of participants: 396
Treatments
Active_comparator: Photon Arm
Standard arm with neoadjuvant chemoradiotherapy (nCXT) with photons
Experimental: Proton Arm
Experimental arm with neoadjuvant chemoradiotherapy (nCPT) with protons
Related Therapeutic Areas
Sponsors
Collaborators: Centre Antoine Lacassagne, Agenzia Nazionale per i Servizi Sanitari Regionali, Centre Leon Berard, The Christie NHS Foundation Trust, University of Leeds, HollandPTC, University College, London, IBA worldwide, Aarhus University Hospital, Institut Curie, CNAO National Center of Oncological Hadrontherapy, Academisch Ziekenhuis Groningen, Technische Universität Dresden, Varian- A Siemens Healthineer Company, Paul Scherrer Institut, Center for Proton Therapy, University College London Hospitals, Maastro Clinic, The Netherlands, KU Leuven
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov