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New treatment option for Esophageal Cancer
Official title PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer
ClinicalTrials.gov ID: NCT06906887
What this study is testing
What is Induction Chemotherapy (modified FLOT or modified FOLFOX-6)?
Induction Chemotherapy (modified FLOT or modified FOLFOX-6) is an investigational medicine, being studied as a potential treatment for esophageal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- 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
- A potential study subject who meets all of the following is eligible to participate in the study.
- 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...
- Currently receiving or have received induction chemotherapy and planned for definitive dose chemoradiation (+/- esophagectomy).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
You likely can't join if
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- Age \< 18 years.
- Extensive distant metastatic cancer, defined as \>5 metastases.
- Recurrent esophageal cancer. a. Note: prior or concurrent malignancies are allowed if they do not impact the study's primary endpoint (i.e...
- Prior non-approved chemotherapy for the treatment of cancer.
- Prior radiotherapy to the region of the study cancer that would result in an overlap of radiation therapy fields.
See the full eligibility criteria
- A potential study subject who meets all of the following is eligible to participate in the study.
- 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.
- Adequate hematologic function within 30 days prior to registration defined as follows:
- Absolute Neutrophil Count ≥ 1,500/mcg
- Hemoglobin ≥ 8 gm/dL
- Platelets ≥ 100,000/mcL.
- Adequate renal function within 30 days prior to registration, defined as a creatinine clearance of ≥ 50 ml/min as calculated by the Cockcroft-Gault equation.
- Adequate hepatic function within 30 days prior to registration, defined as total bilirubin ≤ 1.5 x ULN a. Note: patients with known Gilbert Syndrome can have a total bilirubin \< 2.5 x upper limit of normal (ULN).
- Female patients \<65 years of age and of childbearing potential must have a negative serum/urine pregnancy test within 14 days prior to study entry. A female not of childbearing potential is one who has undergone a...
- Patients of reproductive potential must agree to use effective contraception for the duration of study treatment. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Ability to understand a written informed consent document, and the willingness to sign it.
- A potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.
- Age \< 18 years.
- Extensive distant metastatic cancer, defined as \>5 metastases.
- Recurrent esophageal cancer. a. Note: prior or concurrent malignancies are allowed if they do not impact the study's primary endpoint (i.e., treatment-associated toxicity).
- Prior non-approved chemotherapy for the treatment of cancer.
- Prior radiotherapy to the region of the study cancer that would result in an overlap of radiation therapy fields.
- Women must not be pregnant or breast-feeding.
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
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 Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.