Trial Outcomes & Findings for Chemoradiation and Tetrathiomolybdate (TM) in Patients With Esophageal Carcinoma (NCT NCT00176800)
NCT ID: NCT00176800
Last Updated: 2016-08-22
Results Overview
To measure the time recurrence in patients with esophageal cancer treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
8 years
Results posted on
2016-08-22
Participant Flow
Participant milestones
| Measure |
Chemoradiation and Tetrathiomolybdate (TM)
Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.
|
|---|---|
|
Overall Study
STARTED
|
69
|
|
Overall Study
COMPLETED
|
69
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemoradiation and Tetrathiomolybdate (TM) in Patients With Esophageal Carcinoma
Baseline characteristics by cohort
| Measure |
Chemoradiation and Tetrathiomolybdate (TM)
n=69 Participants
Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.
|
|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 8 yearsTo measure the time recurrence in patients with esophageal cancer treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.
Outcome measures
| Measure |
Chemoradiation and Tetrathiomolybdate (TM)
n=69 Participants
Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.
|
|---|---|
|
Median Recurrence Free Survival Time
|
23.1 months
Interval 12.7 to 60.1
|
SECONDARY outcome
Timeframe: 8 yearsTo measure the survival time in patients treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.
Outcome measures
| Measure |
Chemoradiation and Tetrathiomolybdate (TM)
n=69 Participants
Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.
|
|---|---|
|
Median Overall Survival Time
|
31.5 months
Interval 17.1 to 62.4
|
SECONDARY outcome
Timeframe: 8 yearsOutcome measures
| Measure |
Chemoradiation and Tetrathiomolybdate (TM)
n=69 Participants
Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.
|
|---|---|
|
Percentage of Patients That Require Dose Modification Due to Toxicity
Leukopenia
|
22 percentage of patients
|
|
Percentage of Patients That Require Dose Modification Due to Toxicity
Vomiting
|
6 percentage of patients
|
Adverse Events
Chemoradiation and Tetrathiomolybdate (TM)
Serious events: 28 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemoradiation and Tetrathiomolybdate (TM)
n=69 participants at risk
Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.
|
|---|---|
|
General disorders
Anorexia
|
2.9%
2/69
|
|
Investigations
Bilirubin
|
1.4%
1/69
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
1.4%
1/69
|
|
Cardiac disorders
Cardiovascular/Arrhythmia-Other
|
1.4%
1/69
|
|
Infections and infestations
Catheter-related infection
|
1.4%
1/69
|
|
Musculoskeletal and connective tissue disorders
Chest pain (non-cardiac and non-pleuritic)
|
1.4%
1/69
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/69
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/69
|
|
Nervous system disorders
Depressed level of consciousness
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
1.4%
1/69
|
|
Gastrointestinal disorders
Diarrhea (no colostomy)
|
4.3%
3/69
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
2/69
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
2.9%
2/69
|
|
Investigations
Hypokalemia
|
1.4%
1/69
|
|
Cardiac disorders
Hypotension
|
1.4%
1/69
|
|
Gastrointestinal disorders
Ileus (or neuroconstipation)
|
1.4%
1/69
|
|
Infections and infestations
Infection without neutropenia
|
2.9%
2/69
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
1.4%
1/69
|
|
Gastrointestinal disorders
Nausea
|
5.8%
4/69
|
|
Injury, poisoning and procedural complications
Operative injury of vein/artery
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other
|
1.4%
1/69
|
|
Cardiac disorders
Supraventricular arrhythmias
|
1.4%
1/69
|
|
Vascular disorders
Thrombosis/embolism
|
1.4%
1/69
|
|
Vascular disorders
Thrombotic microangiopathy
|
2.9%
2/69
|
|
Injury, poisoning and procedural complications
Wound-non-infectious
|
1.4%
1/69
|
Other adverse events
| Measure |
Chemoradiation and Tetrathiomolybdate (TM)
n=69 participants at risk
Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.
Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.
Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
44.9%
31/69
|
|
Blood and lymphatic system disorders
Leukopenia
|
78.3%
54/69
|
|
Blood and lymphatic system disorders
Neutopenia
|
27.5%
19/69
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.4%
12/69
|
|
Gastrointestinal disorders
Nausea
|
43.5%
30/69
|
|
Gastrointestinal disorders
Vomiting
|
31.9%
22/69
|
|
Gastrointestinal disorders
Diarrhea
|
10.1%
7/69
|
|
Gastrointestinal disorders
Constipation
|
27.5%
19/69
|
Additional Information
Dr. Susan Urba, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 734-615-4762
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place