Trial Outcomes & Findings for CHFR Methylation Status Esophageal Cancer Study (NCT NCT01372202)
NCT ID: NCT01372202
Last Updated: 2019-01-25
Results Overview
CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
3 years
Results posted on
2019-01-25
Participant Flow
Participant milestones
| Measure |
Arm A
Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy
Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).
|
Arm B
Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu: Oxaliplatin \& 5-fu:
* Oxaliplatin 85 mg/m2 days 1, 15, 29.
* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \& completing on the final day of radiation
Cisplatin/5-fluorouracil:
* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
|
Cisplatin With 5 Fu
Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
9
|
9
|
|
Overall Study
COMPLETED
|
13
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CHFR Methylation Status Esophageal Cancer Study
Baseline characteristics by cohort
| Measure |
Arm A
n=13 Participants
Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy
Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).
|
Arm B
n=9 Participants
Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu: Oxaliplatin \& 5-fu:
* Oxaliplatin 85 mg/m2 days 1, 15, 29.
* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \& completing on the final day of radiation
Cisplatin/5-fluorouracil:
* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
|
Arm C
n=9 Participants
Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
67 years
n=7 Participants
|
60 years
n=5 Participants
|
62 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 yearsCHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma.
Outcome measures
| Measure |
Arm A
n=13 Participants
Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy
Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).
|
Arm B
n=9 Participants
Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu: Oxaliplatin \& 5-fu:
* Oxaliplatin 85 mg/m2 days 1, 15, 29.
* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \& completing on the final day of radiation
Cisplatin/5-fluorouracil:
* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
|
Arm C
n=9 Participants
Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
|
|---|---|---|---|
|
Pathological Complete Response
|
3 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 3 yearsOverall survival with given treatment strategy.
Outcome measures
| Measure |
Arm A
n=13 Participants
Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy
Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).
|
Arm B
n=9 Participants
Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu: Oxaliplatin \& 5-fu:
* Oxaliplatin 85 mg/m2 days 1, 15, 29.
* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \& completing on the final day of radiation
Cisplatin/5-fluorouracil:
* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
|
Arm C
n=9 Participants
Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
|
|---|---|---|---|
|
Survival
|
6 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Study closed due to early stopping rule, therefore data was not collected to assess this outcome measure.
To determine time to disease progression with this treatment strategy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Study closed due to early stopping rule, therefore data was not collected to assess this outcome measure.
To determine the agreement between tumor CHFR methylation and detection in plasma.
Outcome measures
Outcome data not reported
Adverse Events
Arm A
Serious events: 4 serious events
Other events: 4 other events
Deaths: 7 deaths
Arm B
Serious events: 6 serious events
Other events: 1 other events
Deaths: 4 deaths
Arm C
Serious events: 5 serious events
Other events: 7 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm A
n=13 participants at risk
Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy
Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).
|
Arm B
n=9 participants at risk
Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu: Oxaliplatin \& 5-fu:
* Oxaliplatin 85 mg/m2 days 1, 15, 29.
* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \& completing on the final day of radiation
Cisplatin/5-fluorouracil:
* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
|
Arm C
n=9 participants at risk
Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • Number of events 1 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
|
General disorders
Dehydration
|
0.00%
0/13 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
22.2%
2/9 • Number of events 2 • Up to 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/13 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
|
Cardiac disorders
Atrial Fibrliation
|
0.00%
0/13 • Up to 3 years
|
22.2%
2/9 • Number of events 2 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
15.4%
2/13 • Number of events 2 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
General disorders
Failure to thrive
|
7.7%
1/13 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
General disorders
Non-responsive
|
7.7%
1/13 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
General disorders
Pain
|
0.00%
0/13 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Up to 3 years
|
22.2%
2/9 • Number of events 2 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
|
General disorders
Neutropenic Fever
|
7.7%
1/13 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
Cardiac disorders
Orthostatic
|
7.7%
1/13 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
General disorders
Syncope
|
7.7%
1/13 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
|
General disorders
Fever
|
0.00%
0/13 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
Infections and infestations
Bacteremia
|
7.7%
1/13 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
General disorders
Thrombus
|
0.00%
0/13 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
11.1%
1/9 • Number of events 2 • Up to 3 years
|
Other adverse events
| Measure |
Arm A
n=13 participants at risk
Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy
Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).
|
Arm B
n=9 participants at risk
Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
Cisplatin: Paclitaxel and cisplatin:
* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
Cisplatin and 5-fluorouracil:
* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
* Cisplatin 75 mg/m² days 1, 29.
Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.
5-Fu: Oxaliplatin \& 5-fu:
* Oxaliplatin 85 mg/m2 days 1, 15, 29.
* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \& completing on the final day of radiation
Cisplatin/5-fluorouracil:
* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
* Cisplatin 75 mg/m² days 1, 29.
Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
|
Arm C
n=9 participants at risk
Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/13 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
11.1%
1/9 • Number of events 2 • Up to 3 years
|
|
Metabolism and nutrition disorders
Low Potassium
|
7.7%
1/13 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.4%
2/13 • Number of events 3 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
22.2%
2/9 • Number of events 3 • Up to 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.7%
1/13 • Number of events 3 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
11.1%
1/9 • Number of events 2 • Up to 3 years
|
|
Cardiac disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
General disorders
Anorexia
|
0.00%
0/13 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Renal Calculi
|
0.00%
0/13 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/13 • Up to 3 years
|
11.1%
1/9 • Number of events 1 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.7%
1/13 • Number of events 3 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
0.00%
0/9 • Up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place