Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer

June 2, 2022 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate the efficacy of OncoGel given in combination with standard chemotherapy (cisplatin and 5-FU) and radiation therapy in patients with previously untreated, resectable, local or local-regional adenosarcoma or squamous cell carcinoma.

All patients will receive IV cisplatin on Day 1 and Day 29 and IV 5-FU given continuously for 96 hours starting on Day 1 and Day 29. All patients will also receive out-patient radiation therapy for 28 treatments once per day for 5 1/2 weeks starting on Day 1.

Patients randomized to the OncoGel treatment group will have the OncoGel dose injected into their esophageal tumors during an endoscopic procedure just before starting systemic chemotherapy and radiation therapy.

All patients will have CT scans for tumor measurements before starting chemotherapy and 12 weeks later after completion of the radiation therapy and both cycles of chemotherapy.

During the chemotherapy and radiation therapy, physical exams, vital signs, routine blood tests will be performed. Patients will also be asked about their quality of life and ability to swallow.

In-patient surgery will be scheduled 4 to 6 weeks after completion of chemotherapy and radiation therapy. The resected esophagus and lymph nodes will be evaluated for the presence of residual tumor.

Patients will be followed at months 4, 5, 6, and then every 3 Months thereafter for survival and esophageal cancer status and treatment until the last patient enrolled has completed their Month 12 visit.

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 62500
        • University Hospital Brno
      • Jablonec nad Nisou, Czechia, 466 60
        • Hospital Jablonec nad Nisou
      • Olomouc, Czechia, 775 20
        • University Hospital Olomouc
      • Praha, Czechia, 150 06
        • University Hospital Motol
      • Usti nad Labem, Czechia, 401 13
        • Massaryk's Hospital in Usti nad Labem
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560029
        • Kidwai Memorial Institute of Oncology
    • Kerala
      • Kochi, Kerala, India, 682026
        • Amrita Institute of Medical Sciences
    • Maharashtra
      • Mumbai, Maharashtra, India, 400020
        • Bombay Hospital & Medical Research Centre
    • Pune
      • Erandwane, Pune, India, 411004
        • Deenanath Mangeshkar Hospital
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625107
        • Meenakshi Mission Hospital and Research Centre
  • Poland
      • Lublin, Poland, 20-081
        • Samodzielny Publiczny Szpital Kliniczny
      • Szczecin, Poland, 70-111
        • Samodzielnego Publicznego Szpitala Klinicznego
  • United States
    • California
      • San Diego, California, United States, 92093
        • University of California San Diego
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Tyler, Texas, United States, 75701
        • Digestive Health Specialists of Tyler, Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Medically able to tolerate major abdominal and/or thoracic surgery
  3. Able to undergo EUS procedure and pass EUS probe through esophageal lumen
  4. Able to receive concurrent systemic chemotherapy (cisplatin and 5-FU) and RT
  5. Clinical management plan includes esophagectomy after completion of two courses of chemoradiation therapy
  6. Karnofsky Performance Status of ≥ 60
  7. Minimum life expectancy of 4 months

  8. Hematologic function

    • Absolute neutrophil count (ANC) ≥ 1500/mm3
    • Platelet count ≥ 100,000/mm3
    • Hemoglobin ≥ 9 g/dL

  9. Hepatic function:

    • Total bilirubin < 1.5 X upper limit of normal (ULN)
    • AST and ALT < 3 X ULN
    • Albumin ≥ 3.0 g/dL or ≥ 2.0 g/dL if the lower level is considered by the investigator to be due to nutritional depletion
  10. Serum creatinine < 1.5 mg/dL and/or creatinine clearance ≥ 65 mL/min
  11. ≥ 18 years old
  12. If female, must be non-pregnant, nonlactating, of non-childbearing potential, or using adequate birth control
  13. Capable of understanding and agreeing to fulfill the requirements of the protocol
  14. Sign the IRB/EC approved consent form

Exclusion Criteria:

  1. History of anaphylaxis to planned CT contrast agent
  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.
  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. 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
  7. 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
  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 adversely affect subject safety
  11. Known esophageal varices

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Drug: OncoGel (Paclitaxel gel)
6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy
Drug: cisplatin
75 mg/m2 IV (in the vein) once on Day 1 and Day 29
Drug: 5-FU
1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29
Radiation: radiation therapy
50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks
Procedure: esophageal resection
Removal of esophagus after completion of chemotherapy and radiation therapy
ACTIVE_COMPARATOR: Group 2
Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Drug: cisplatin
75 mg/m2 IV (in the vein) once on Day 1 and Day 29
Drug: 5-FU
1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29
Radiation: radiation therapy
50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks
Procedure: esophageal resection
Removal of esophagus after completion of chemotherapy and radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT
Time Frame: Screening and Week 12

Per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and by Spiral CT assessment:

Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is a >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Screening and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Kirk D Fowers, PhD, Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (ESTIMATE)

December 13, 2007

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR016-CLN-pro003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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