Trial Outcomes & Findings for Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer (NCT NCT00193128)
NCT ID: NCT00193128
Last Updated: 2021-11-24
Results Overview
The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
59 participants
Primary outcome timeframe
18 months
Results posted on
2021-11-24
Participant Flow
Participant milestones
| Measure |
Oxaliplatin/Docetaxel/Radiation (Cohort 1)
oxaliplatin, docetaxel and radiation therapy
Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began.
|
Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)
Oxaliplatin, docetaxel, capecitabine, and radiation therapy.
Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
49
|
|
Overall Study
COMPLETED
|
10
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
Baseline characteristics by cohort
| Measure |
Oxaliplatin/Docetaxel/Radiation (Cohort 1)
n=10 Participants
oxaliplatin, docetaxel and radiation therapy
Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began.
|
Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)
n=49 Participants
Oxaliplatin, docetaxel, capecitabine, and radiation therapy.
Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
63 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
49 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy
The absence of any residual tumor cells in a histologic evaluation of a tumor specimen following surgery is defined as a complete pathologic response
Outcome measures
| Measure |
Oxaliplatin/Docetaxel/Radiation (Cohort 1)
Oxaliplatin, docetaxel, and radiation therapy.
Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began.
|
Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)
n=49 Participants
Oxaliplatin, docetaxel, capecitabine, and radiation therapy.
Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported.
|
|---|---|---|
|
Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery
|
—
|
24 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy
Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.
Outcome measures
| Measure |
Oxaliplatin/Docetaxel/Radiation (Cohort 1)
Oxaliplatin, docetaxel, and radiation therapy.
Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began.
|
Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)
n=49 Participants
Oxaliplatin, docetaxel, capecitabine, and radiation therapy.
Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported.
|
|---|---|---|
|
Disease-Free Survival (DFS)
|
—
|
16.3 months
Interval 4.5 to 31.5
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
Outcome measures
| Measure |
Oxaliplatin/Docetaxel/Radiation (Cohort 1)
Oxaliplatin, docetaxel, and radiation therapy.
Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began.
|
Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)
n=49 Participants
Oxaliplatin, docetaxel, capecitabine, and radiation therapy.
Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported.
|
|---|---|---|
|
Overall Survival (OS)
|
—
|
24.1 months
Interval 11.4 to 36.0
|
Adverse Events
Oxaliplatin/Docetaxel/Radiation (Cohort 1)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)
Serious events: 33 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxaliplatin/Docetaxel/Radiation (Cohort 1)
n=10 participants at risk
Oxaliplatin, docetaxel, and radiation therapy.
Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began.
|
Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)
n=49 participants at risk
Oxaliplatin, docetaxel, capecitabine, and radiation therapy.
Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported.
|
|---|---|---|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/10
|
8.2%
4/49 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
10.0%
1/10 • Number of events 1
|
8.2%
4/49 • Number of events 4
|
|
Infections and infestations
Infection - Pneumonia
|
0.00%
0/10
|
4.1%
2/49 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratary - Other
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/10
|
12.2%
6/49 • Number of events 6
|
|
Gastrointestinal disorders
Perforation, GI
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Fistula, GI
|
10.0%
1/10 • Number of events 1
|
4.1%
2/49 • Number of events 2
|
|
General disorders
Death
|
0.00%
0/10
|
14.3%
7/49 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10
|
4.1%
2/49 • Number of events 2
|
|
General disorders
Pain - Abdomen
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Stricture, GI
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
0.00%
0/10
|
6.1%
3/49 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
GI - Other
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
General disorders
Pain - Back
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
Nervous system disorders
CNS Ischemia
|
0.00%
0/10
|
4.1%
2/49 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
|
Infections and infestations
Infection - Sepsis
|
0.00%
0/10
|
2.0%
1/49 • Number of events 1
|
Other adverse events
| Measure |
Oxaliplatin/Docetaxel/Radiation (Cohort 1)
n=10 participants at risk
Oxaliplatin, docetaxel, and radiation therapy.
Ten patients were enrolled on the phase I cohort 1 portion of the trial. The combination was tolerated and phase I cohort 2 subsequently began.
|
Oxaliplatin/Docetaxel/Capecitabine/Radiation (Cohort 2)
n=49 participants at risk
Oxaliplatin, docetaxel, capecitabine, and radiation therapy.
Ten patients were enrolled in phase I cohort 2; an additional 39 patients were subsequently enrolled in the phase II portion and treated with the phase I cohort 2 regimen. Data from all 49 patients receiving the cohort 2 regimen was analyzed and reported.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
30.0%
3/10 • Number of events 6
|
38.8%
19/49 • Number of events 51
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
5/10 • Number of events 12
|
46.9%
23/49 • Number of events 101
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
10.0%
1/10 • Number of events 1
|
6.1%
3/49 • Number of events 6
|
|
General disorders
Pain - joint
|
10.0%
1/10 • Number of events 1
|
0.00%
0/49
|
|
General disorders
Cold intolerance
|
20.0%
2/10 • Number of events 6
|
6.1%
3/49 • Number of events 9
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 3
|
32.7%
16/49 • Number of events 45
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
3/10 • Number of events 4
|
46.9%
23/49 • Number of events 63
|
|
General disorders
Pain - abdomen
|
10.0%
1/10 • Number of events 2
|
0.00%
0/49
|
|
General disorders
Pain - chest
|
10.0%
1/10 • Number of events 1
|
0.00%
0/49
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1
|
6.1%
3/49 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Number of events 4
|
0.00%
0/49
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Number of events 2
|
6.1%
3/49 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia
|
30.0%
3/10 • Number of events 15
|
38.8%
19/49 • Number of events 76
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 6
|
0.00%
0/49
|
|
Gastrointestinal disorders
Esophagitis
|
30.0%
3/10 • Number of events 14
|
51.0%
25/49 • Number of events 92
|
|
Gastrointestinal disorders
Fistula - esophagus
|
10.0%
1/10 • Number of events 1
|
0.00%
0/49
|
|
General disorders
Fatigue
|
100.0%
10/10 • Number of events 38
|
73.5%
36/49 • Number of events 171
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1
|
26.5%
13/49 • Number of events 26
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
10.0%
1/10 • Number of events 1
|
0.00%
0/49
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Number of events 5
|
12.2%
6/49 • Number of events 10
|
|
Cardiac disorders
Hypotension
|
20.0%
2/10 • Number of events 5
|
8.2%
4/49 • Number of events 17
|
|
General disorders
Insomnia
|
10.0%
1/10 • Number of events 5
|
18.4%
9/49 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
10.0%
1/10 • Number of events 1
|
0.00%
0/49
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
1/10 • Number of events 3
|
0.00%
0/49
|
|
Blood and lymphatic system disorders
Leukocytes
|
10.0%
1/10 • Number of events 2
|
30.6%
15/49 • Number of events 32
|
|
Gastrointestinal disorders
Nausea
|
70.0%
7/10 • Number of events 22
|
71.4%
35/49 • Number of events 112
|
|
Nervous system disorders
Neuropathy
|
30.0%
3/10 • Number of events 18
|
10.2%
5/49 • Number of events 9
|
|
Infections and infestations
Infection - pneumonia
|
10.0%
1/10 • Number of events 1
|
6.1%
3/49 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.0%
1/10 • Number of events 1
|
0.00%
0/49
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
10.0%
1/10 • Number of events 1
|
0.00%
0/49
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1
|
16.3%
8/49 • Number of events 18
|
|
Infections and infestations
Infection - sepsis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/49
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Number of events 2
|
0.00%
0/49
|
|
Blood and lymphatic system disorders
Platelets
|
30.0%
3/10 • Number of events 6
|
38.8%
19/49 • Number of events 47
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
10.0%
1/10 • Number of events 4
|
0.00%
0/49
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Number of events 4
|
40.8%
20/49 • Number of events 36
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10
|
10.2%
5/49 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10
|
6.1%
3/49 • Number of events 14
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/10
|
38.8%
19/49 • Number of events 42
|
|
Blood and lymphatic system disorders
Edema NOS
|
0.00%
0/10
|
6.1%
3/49 • Number of events 9
|
|
Gastrointestinal disorders
Gastroesophageal reflux disorder
|
0.00%
0/10
|
6.1%
3/49 • Number of events 5
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/10
|
6.1%
3/49 • Number of events 8
|
|
Infections and infestations
Infection NOS
|
0.00%
0/10
|
18.4%
9/49 • Number of events 18
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/10
|
10.2%
5/49 • Number of events 9
|
|
General disorders
Pain NOS
|
0.00%
0/10
|
6.1%
3/49 • Number of events 7
|
|
General disorders
Pain - throat
|
0.00%
0/10
|
14.3%
7/49 • Number of events 34
|
|
General disorders
Weight loss
|
0.00%
0/10
|
10.2%
5/49 • Number of events 13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER