Trial Outcomes & Findings for Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer (NCT NCT00573131)

Last Updated: 2022-06-22

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

137 participants

Primary outcome timeframe

Screening and Week 12

Results posted on

2022-06-22

Participant Flow

Patients were enrolled from 21 Jan 2008 through 05 Nov 2010 at 20 centers in 5 countries (United States, India, Poland, Czech Republic and Belgium).

Participant milestones

Participant milestones
Measure	Group 1 OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.	Group 2 Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Overall Study STARTED	72	65
Overall Study COMPLETED	62	57
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.	Group 2 Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Overall Study Withdrawal by Subject	10	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=72 Participants OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.	Group 2 n=65 Participants Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.	Total n=137 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=93 Participants	48 Participants n=4 Participants	103 Participants n=27 Participants
Age, Categorical >=65 years	17 Participants n=93 Participants	17 Participants n=4 Participants	34 Participants n=27 Participants
Age, Continuous	58.4 years STANDARD_DEVIATION 7.2 • n=93 Participants	57.6 years STANDARD_DEVIATION 10.9 • n=4 Participants	58.0 years STANDARD_DEVIATION 9.1 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	21 Participants n=4 Participants	40 Participants n=27 Participants
Sex: Female, Male Male	53 Participants n=93 Participants	44 Participants n=4 Participants	97 Participants n=27 Participants
Region of Enrollment United States	13 participants n=93 Participants	9 participants n=4 Participants	22 participants n=27 Participants
Region of Enrollment Czech Republic	14 participants n=93 Participants	11 participants n=4 Participants	25 participants n=27 Participants
Region of Enrollment Poland	8 participants n=93 Participants	9 participants n=4 Participants	17 participants n=27 Participants
Region of Enrollment Belgium	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Region of Enrollment India	37 participants n=93 Participants	35 participants n=4 Participants	72 participants n=27 Participants

PRIMARY outcome

Timeframe: Screening and Week 12

Population: Subjects who received at least one treatment with OncoGel, systemic chemotherapy or external beam radiation therapy were included for analysis of efficacy.

Outcome measures

Outcome measures
Measure	Group 1 n=72 Participants OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.	Group 2 n=65 Participants Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT	12.5 percentage of patients	20.0 percentage of patients

Adverse Events

Group 1

Serious events: 30 serious events

Other events: 67 other events

Deaths: 0 deaths

Group 2

Serious events: 20 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Jessie Stockwell

Boston Scientific Corporation

Phone: 1-612-618-1136

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Group 1 n=72 participants at risk OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.	Group 2 n=65 participants at risk Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Blood and lymphatic system disorders Anaemia	8.3% 6/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	10.8% 7/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Blood and lymphatic system disorders Leukopenia	23.6% 17/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	12.3% 8/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Blood and lymphatic system disorders Neutropenia	8.3% 6/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	13.8% 9/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Blood and lymphatic system disorders Thrombocytopenia	16.7% 12/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	12.3% 8/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Gastrointestinal disorders Abdominal pain	11.1% 8/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	7.7% 5/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Gastrointestinal disorders Constipation	19.4% 14/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	13.8% 9/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Gastrointestinal disorders Diarrhoea	15.3% 11/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	15.4% 10/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Gastrointestinal disorders Dysphagia	9.7% 7/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	13.8% 9/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Gastrointestinal disorders Nausea	33.3% 24/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	16.9% 11/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Gastrointestinal disorders Odynophagia	8.3% 6/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	6.2% 4/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Gastrointestinal disorders Oesophagitis	6.9% 5/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	4.6% 3/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Gastrointestinal disorders Vomiting	18.1% 13/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	23.1% 15/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
General disorders Asthenia	4.2% 3/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	6.2% 4/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
General disorders Chest pain	15.3% 11/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	9.2% 6/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
General disorders Fatigue	15.3% 11/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	13.8% 9/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
General disorders Mucosal inflammation	6.9% 5/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	7.7% 5/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
General disorders Pyrexia	18.1% 13/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	18.5% 12/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Investigations Weight decreased	19.4% 14/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	18.5% 12/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Metabolism and nutrition disorders Anorexia	9.7% 7/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	13.8% 9/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Metabolism and nutrition disorders Dehydration	6.9% 5/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	4.6% 3/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Metabolism and nutrition disorders Hypokalaemia	4.2% 3/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	10.8% 7/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	6.2% 4/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Musculoskeletal and connective tissue disorders Back pain	6.9% 5/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	4.6% 3/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Nervous system disorders Dizziness	5.6% 4/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	6.2% 4/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Psychiatric disorders Insomnia	8.3% 6/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	6.2% 4/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Respiratory, thoracic and mediastinal disorders Cough	6.9% 5/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	20.0% 13/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Respiratory, thoracic and mediastinal disorders Hiccups	5.6% 4/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	6.2% 4/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit
Vascular disorders Hypotension	1.4% 1/72 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit	7.7% 5/65 • Adverse events were collected through the 12 week Assessment Period Serious adverse events were collected through the first 30 days after the Week 12 visit