Esophageal CancerPhase 2NCT00573131
Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer
A Phase 2 study testing OncoGel (Paclitaxel gel), cisplatin and 5-FU in people with Esophageal Cancer and Adenocarcinoma of the Esophagus, run by Boston Scientific Corporation at 20 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Adenocarcinoma of the Esophagus, Squamous Cell Carcinoma
- What is being tested?
- OncoGel (Paclitaxel gel), cisplatin and 5-FU
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 20 sitesin 4 countries
- Study dates
- Jan 2008to Nov 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Minimum life expectancy of 4 months
- Hematologic function
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- 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
- Serum creatinine < 1.5 mg/dL and/or creatinine clearance ≥ 65 mL/min
- ≥ 18 years old
- If female, must be non-pregnant, nonlactating, of non-childbearing potential, or using adequate birth control
- Capable of understanding and agreeing to fulfill the requirements of the protocol
- Sign the IRB/EC approved consent form
Who cannot join
- History of anaphylaxis to planned CT contrast agent
- 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
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- 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])
- Receipt of an investigational drug or device within 30 days prior to signing informed consent
- 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
- Known esophageal varices
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States8 sites
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
Baylor University Medical Center
Dallas, Texas, 75246
Indiana University Medical Center
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of California San Diego
San Diego, California, 92093
Digestive Health Specialists of Tyler, Texas
Tyler, Texas, 75701
Czechia5 sites
University Hospital Brno
Brno, 62500
Hospital Jablonec nad Nisou
Jablonec nad Nisou, 466 60
University Hospital Olomouc
Olomouc, 775 20
University Hospital Motol
Prague, 150 06
Massaryk's Hospital in Usti nad Labem
Ústí nad Labem, 401 13
India5 sites
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, 560029
Deenanath Mangeshkar Hospital
Erandwane, Pune, 411004
Amrita Institute of Medical Sciences
Kochi, Kerala, 682026
Meenakshi Mission Hospital and Research Centre
Madurai, Tamil Nadu, 625107
Bombay Hospital & Medical Research Centre
Mumbai, Maharashtra, 400020
Poland2 sites
Samodzielny Publiczny Szpital Kliniczny
Lublin, 20-081
Samodzielnego Publicznego Szpitala Klinicznego
Szczecin, 70-111
About this study
Official title: 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.
Read the 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.
- Keywords
- Esophageal cancer, Localized esophageal cancer, Operable esophageal cancer, Loco-regional esophageal cancer, Esophagectomy, Phase 2, Paclitaxel, Tumor, Local, Chemotherapy, radiation therapy, surgery, OncoGel, Squamous cell carcinoma of the esophagus
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Carcinoma, Squamous Cell, Neoplasms, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoGel (Paclitaxel gel)Drug
6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy
cisplatinDrug
75 mg/m2 IV (in the vein) once on Day 1 and Day 29
5-FUDrug
1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29
radiation therapyRadiation
50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks
esophageal resectionProcedure or surgery
Removal of esophagus after completion of chemotherapy and radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection. Receives: Drug: OncoGel (Paclitaxel gel); Drug: cisplatin; Drug: 5-FU; Radiation: radiation therapy; Procedure: esophageal resection |
| Group 2 | Active comparator | Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection. Receives: Drug: cisplatin; Drug: 5-FU; Radiation: radiation therapy; Procedure: esophageal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT
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
Measured: Screening and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: OncoGel did not show any impact on overall tumor response
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirk D Fowers, PhD, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573131
- Sponsor's protocol ID
- PR016-CLN-pro003
- Status last verified
- Jun 2022
- First submitted
- 11 Dec 2007
- Last updated
- 22 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
DeWitt JM, Murthy SK, Ardhanari R, DuVall GA, Wallner G, Litka P, Daugherty C, Fowers K. EUS-guided paclitaxel injection as an adjunctive therapy to systemic chemotherapy and concurrent external beam radiation before surgery for localized or locoregional esophageal cancer: a multicenter prospective randomized trial. Gastrointest Endosc. 2017 Jul;86(1):140-149. doi: 10.1016/j.gie.2016.11.017. Epub 2016 Nov 24.
PubMed 27890801
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00573131
- Acronym / sponsor ID
- PR016-CLN-pro003
- Keywords
- Esophageal cancer, Localized esophageal cancer, Operable esophageal cancer, Loco-regional esophageal cancer, Esophagectomy, Phase 2, Paclitaxel, Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: OncoGel did not show any impact on overall tumor response
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Posted 16 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: OncoGel (Paclitaxel gel), Drug: cisplatin, Drug: 5-FU, Radiation: radiation therapy, Procedure: esophageal resectionOncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection. |
| Group 2 | Active comparator | Drug: cisplatin, Drug: 5-FU, Radiation: radiation therapy, Procedure: esophageal resectionRadiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (11 listed)
- History of anaphylaxis to planned CT contrast agent
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncoGel (Paclitaxel gel)6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy | Drug | Group 1 |
| cisplatin75 mg/m2 IV (in the vein) once on Day 1 and Day 29 | Drug | Group 1, Group 2 |
| 5-FU1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29 | Drug | Group 1, Group 2 |
| radiation therapy50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks | Radiation | Group 1, Group 2 |
| esophageal resectionRemoval of esophagus after completion of chemotherapy and radiation therapy | Procedure or surgery | Group 1, Group 2 |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27890801DeWitt JM, Murthy SK, Ardhanari R, DuVall GA, Wallner G, Litka P, Daugherty C, Fowers K. EUS-guided paclitaxel injection as an adjunctive therapy to systemic chemotherapy and concurrent external beam radiation before surgery for localized or locoregional esophageal cancer: a multicenter prospective randomized trial. Gastrointest Endosc. 2017 Jul;86(1):140-149. doi: 10.1016/j.gie.2016.11.017. Epub 2016 Nov 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk D Fowers, PhD study director
Boston Scientific Corporation
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OncoGel (Paclitaxel gel), cisplatin and 5-FU in people with Esophageal Cancer and Adenocarcinoma of the Esophagus, run by Boston Scientific Corporation at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Czechia, India, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00573131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.