PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin
About this trial
This is a prospective, randomized, open-label, two-arm phase 2 trial that will evaluate whether the use of Pulsed Low-Dose-Rate radiation technique, as compared to standard radiation, is associated with reduced rates of clinically significant esophagitis during and following chemoradiation.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Stage II-IVb adenocarcinoma of the esophagus (if IVb, oligometastatic only, felt to be eligible for definitive dose CRT treatment by treating physician).
Currently receiving or have received induction chemotherapy and planned for definitive dose chemoradiation (+/- esophagectomy).
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Disqualifiers
Age < 18 years.
Extensive distant metastatic cancer, defined as >5 metastases.
Recurrent esophageal cancer.
Prior non-approved chemotherapy for the treatment of cancer.
Trial design
Treatments tested in this trial
- Induction Chemotherapy (modified FLOT or modified FOLFOX-6)
- Chemotherapy
- Conventional Radiation
- Pulsed Low-Dose-Rate (PLDR) Radiation
- Surgery
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov