Health Trials

PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer

ConditionsEsophageal CancerOesophageal CancerGastroEsophageal 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Induction Chemotherapy (modified FLOT or modified FOLFOX-6)

    Drug

    Subjects are expected to receive 2-4 months of induction chemotherapy; the interval and dosages will be determined and can be modified at the discretion of their medical oncologist. The preferred induction chemotherapies are modified FLOT or FOLFOX-6. Subjects can enroll if they receive less than 2 months of induction chemotherapy as long as they are deemed to be a candidate for concurrent chemoradiation therapy.

  • Chemotherapy

    Drug

    The preferred concurrent chemoradiation is carboplatin/paclitaxel weekly.

  • Conventional Radiation

    Radiation

    For both standard conventional radiation therapy and PLDR radiation therapy, the standard dose (5000cGy/25fx default, 4140-5040 in 23-28 fractions) should be given. Fractions should consist of 180-200 cGy per treatment.

  • Pulsed Low-Dose-Rate (PLDR) Radiation

    Radiation

    For both standard conventional radiation therapy and PLDR radiation therapy, the standard dose (5000cGy/25fx default, 4140-5040 in 23-28 fractions) should be given. Fractions should consist of 180-200 cGy per treatment. For PLDR radiation therapy, each fraction will be delivered as a series of 20 cGy (or 0.2 Gy) pulses that are separated by 3-minute time intervals.

  • Surgery

    Procedure/Surgery

    Esophagectomy is not required for trial and will be administered per medical judgement of the treating physicians. Surgery will take place at the time directed by the surgeon. This typically will take place approximately 6-13 weeks after chemoradiation therapy.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Pulsed Low-Dose-Rate Radiation (PLDR)Experimental treatment 4 interventions
Group B: Standard ChemoradiationExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

New prescription for narcotics

The number of subjects requiring a new prescription for narcotics.

Time frame
Up to 6 weeks after radiation treatment
2

Increasing existing narcotics

The number of subjects increasing existing narcotics by 25%.

Time frame
Up to 6 weeks after radiation treatment
3

Oral intake

The number of subjects transitioning from solid to liquid or liquid to no oral intake.

Time frame
Up to 6 weeks after radiation therapy

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov
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