A randomized study of the efficacy and safety of OncoGel™ treatment as an adjunctive therapy to systemic chemotherapy and concurrent external beam radiation prior to surgery in subjects with localized or loco-regional esophageal cancer

Protherics Salt Lake City, Inc0 sites156 target enrollmentFebruary 12, 2008

Conditionslocalized or loco-regional esophageal cancer MedDRA version: 9.1Level: LLTClassification code 10015362Term: Esophageal cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: localized or loco-regional esophageal cancer
Sponsor: Protherics Salt Lake City, Inc
Enrollment: 156
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 12, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Protherics Salt Lake City, Inc

Eligibility Criteria

Inclusion Criteria

•1\) Disease criteria: Subject’s esophageal cancer must meet all of the following:
•a) Confirmation: Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction. Biopsy or cytology of the primary tumor or of involved regional lymph nodes is acceptable.
•b) Stage: Tumors must be TNM stage T2\-T3, N any, M0 (no evidence of disseminated cancer except regional node involvement which may be designated as M1a”) as determined by endoscopic ultrasound.
•c) Disease extent: Disease must be limited to the esophagus or the gastroesophageal junction, including:
•i)Tumor does not extend more than 2 cm into the stomach
•ii)Tumor does not extend into proximal one\-third of the esophagus (Note: Bronchoscopy is required if tumor is \<26 cm from the incisors or at or above the carina)
•iii)No tracheal\-esophageal fistulas present
•iv) No apparent direct invasion by the tumor into the mucosa of the trachea or major bronchus as determined by bronchoscopy or other method.
•v) No vascular invasion or involvement by the tumor
•d) No evidence of metastatic disease: disease must be localized to the esophagus, including

Exclusion Criteria

•1\) History of anaphylaxis to planned CT contrast agent; subjects with history of minor, mild allergic reactions (eg hives, rash, pruritis) to planned CT contrast agent may be premedicated with prednisone or other medications per institutional standard of care
•2\) Prior esophageal stent insertion, laser or photodynamic therapy
•3\) Prior chest RT or major esophageal surgery
•4\) Any prior receipt of cytotoxic chemotherapeutic agents
•5\) 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. Note: hormonal therapies (eg tamoxifen, anastrozole) and topical agents (eg 5\-FU, imiquimod) will be allowed; no washout period will be required for these agents.
•6\) 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. In addition, subjects with history of low risk prostatic carcinoma (ie clinical stage 1 or 2a, Gleason score \<6, and prostate\-specific antigen (PSA) \<10 ng/mL at diagnosis) will be allowed.
•7\) Significant currently active systemic diseases including uncontrolled diabetes, severe heart disease (New York Heart Association Class III or IV, see Section 13\.4\), uncontrolled hypertension, myocardial infarction within 3 months, severe bronchial obstruction, uncontrolled seizure disorder, peripheral neuropathy greater than CTCAE grade 1, or any disease requiring anticoagulant therapy
•8\) Allergies to any of the active or inactive components of OncoGel (ie allergies to degradable PLGA \[poly(lactide\-co\-glycolide) sutures])
•9\) Receipt of an investigational drug or device within 30 days prior to signing informed consent
•10\) Any medical condition or other circumstance that, in the Investigator’s opinion, would prevent completion of the study, interfere with analysis of the study results, or potentially aversely affect subject safety.