Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects Wi… (NCT00573131) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of OncoGelâ„¢ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer
Stopped: OncoGel did not show any impact on overall tumor response
United States137 participantsStarted 2008-01
Plain-language summary
OncoGel is a new experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.
The protocol is directed towards evaluating the efficacy and safety of paclitaxel delivered as a local, intralesional treatment when used in combination with chemotherapy (cisplatin and 5-FU) and radiation therapy before surgery.
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
✓. Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus. Stage T2-T3, N any, M0 (no evidence of disseminated cancer except regional involvement which may be designated as "M1a"). No evidence of metastatic disease
✓. Medically able to tolerate major abdominal and/or thoracic surgery
✓. Able to undergo EUS procedure and pass EUS probe through esophageal lumen
✓. Able to receive concurrent systemic chemotherapy (cisplatin and 5-FU) and RT
✓. Clinical management plan includes esophagectomy after completion of two courses of chemoradiation therapy
✓. Karnofsky Performance Status of ≥ 60
✓. Minimum life expectancy of 4 months
✓. Hematologic function
Exclusion criteria
✕. History of anaphylaxis to planned CT contrast agent
What they're measuring
1
Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT
. Prior esophageal stent insertion, laser, or photodynamic therapy
✕. Prior chest RT or major esophageal surgery
✕. Any prior receipt of cytotoxic chemotherapeutic agents
✕. Prior receipt of other cancer treatments (ie, Chelation therapy), vaccines, or biological response modifiers/growth factors (ie, GM-CSF, IL-2) within the past 4 weeks.
✕. Prior malignancy unless disease free for ≥ 3 years. Note: basal cell/squamous carcinoma of the skin, in situ cervical or breast carcinoma, or superficial transitional cell bladder carcinoma will be allowed. Subjects with a history of low risk prostatic carcinoma (ie, clinical stage 1 or 2a, Gleason score \< or = 6 and PSA \<10 ng/mL at diagnosis) will be allowed
✕. Significant currently active systemic diseases including uncontrolled diabetes, severe heart disease (New York Heart Association Class III or IV), uncontrolled hypertension, myocardial infarction within 3 months, severe bronchial obstruction, uncontrolled seizure disorder, or peripheral neuropathy greater than CTCAE grade 1
✕. Allergies to any of the active or inactive components of OncoGel (ie, allergies to degradable PLGA \[poly(lactide-co-glycolide) sutures\])