A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of t… (NCT03133650) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing
United States, Israel12 participantsStarted 2017-04-26
Plain-language summary
The purpose of this study is to establish the highest dose of laser light for WST-11 VTP to treat obstruction from esophageal cancer that can be safely given.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or older
* Confirmed tissue diagnosis of esophageal squamous cell cancer, adenocarcinoma or poorly differentiated carcinoma, with pathology reviewed at MSKCC
* Has incurable disease defined as at least one of the following:
* Presence of metastases to other organs (Stage IV), now or previously
* Has locally advanced disease and are not candidates for surgery or more radiation treatment
* Has received the maximal radiation therapy to the primary site, or has been assessed by radiation oncology as not being a candidate for chemoradiation therapy.
* Karnofsky performance status \>/= 50%
* No endoluminal stent in place at the time of treatment
* Previous esophageal dilation is permitted, provided the patient has developed recurrent dysphagia since that procedure
* Patients should not have received any systemic therapy (including chemotherapy, biologic therapy or immunotherapy) \</= 7 days prior to treatment
* Prior radiation or surgery to the esophagus is permitted for patients with locally recurrent/persistent disease
* Patients on prophylactic or full-dose anticoagulation are eligible, provided the treating physician believes it is safe to temporarily withhold anticoagulation (see Section 9.2)
* Adequate organ function defined at baseline as:
* ANC ≥1,000/ L
* Platelets ≥75,000/ L
* Hb ≥8.5 g/dl
* INR ≤1.5 (except for patients who are on full-dose warfarin)
* Calculated creatinine clearance ≥50 ml/min (using Cockcroft-Gault method…