About this trial
This study aims to show that the addition of carboplatin and paclitaxel chemotherapy to a palliative course of external beam radiation treatment improves both dysphagia relief and patient quality of life in patients with unresectable esophageal cancer.
Eligibility criteria
Qualifiers
Biopsy proven carcinoma of the esophagus.
Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness.
Symptomatic patients with Mellow Dysphagia Scores of ≥ 1 i.e. able to eat only some solids.
ECOG Performance status ≤ 2.
Disqualifiers
Previous radiotherapy delivered to the chest.
Synchronous active malignancies.
Pregnant or lactating patients: women of child bearing potential must have a negative serum pregnancy test within 7 days of Treatment Visit 1. Women or men of child bearing potential must use effective contraception (defined by the use of two birth control methods, which can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy). Subjects must start using birth control from the time they have signed the Informed Consent Form prior to start of therapy until 120 days post completion of study therapy or study discontinuation, which must be documented in the eCRF.
Patients unfit for any treatment component, including absolute contraindications for radiotherapy or Connective Tissue Disease.
Trial design
Treatments tested in this trial
- Carboplatin and Taxol (paclitaxel)
- External Beam Radiation