Trial Outcomes & Findings for Radiation Dose Escalation in Esophageal Cancer (NCT NCT03082586)
NCT ID: NCT03082586
Last Updated: 2020-12-22
Results Overview
The DLTs were defined as grade \>/=4 esophatitis, any other grade \>/=3 nonhematological toxicity (except nausea and vomiting), or grade \>/=4 hematological toxicity lasting more than 7 days, which are possibly, probably, or definitely associated with protocol treatment occurring during and after completion of the HFRT boost treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
15 months
Results posted on
2020-12-22
Participant Flow
Participant milestones
| Measure |
Radiochemotherapy 1
Patients will be treated with radiation therapy 57.2 Gy.
radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly
|
Radiochemotherapy 2
Patients will be treated with radiation therapy 64.4 Gy.
radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Radiochemotherapy 3
Patients will be treated with radiation therapy 71.6 Gy.
radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Radiochemotherapy 4
Patients will be treated with radiation therapy 78.8 Gy.
radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Radiochemotherapy 5
Patients will be treated with radiation therapy 86 Gy.
radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Radiochemotherapy 6
Patients will be treated with radiation therapy 93.2 Gy.
radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
13
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
6
|
13
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Radiochemotherapy 1
n=3 Participants
3 Patients will be treated with radiation therapy 57.2 Gy.
radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly
|
Radiochemotherapy 2
n=3 Participants
3 Patients will be treated with radiation therapy 64.4 Gy.
radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Radiochemotherapy 3
n=3 Participants
3 Patients will be treated with radiation therapy 71.6 Gy.
radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Radiochemotherapy 4
n=6 Participants
6 Patients will be treated with radiation therapy 78.8 Gy.
radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Radiochemotherapy 5
n=13 Participants
13 Patients will be treated with radiation therapy 86 Gy.
radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Radiochemotherapy 6
n=3 Participants
3 Patients will be treated with radiation therapy 93.2 Gy.
radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
8 Participants
n=13 Participants
|
1 Participants
n=3 Participants
|
17 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=13 Participants
|
2 Participants
n=3 Participants
|
14 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=13 Participants
|
0 Participants
n=3 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
8 Participants
n=13 Participants
|
3 Participants
n=3 Participants
|
23 Participants
n=31 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
6 participants
n=6 Participants
|
13 participants
n=13 Participants
|
3 participants
n=3 Participants
|
31 participants
n=31 Participants
|
|
Eastern Cooperative Oncology Group, ECOG performance status 0-1
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
12 Participants
n=13 Participants
|
3 Participants
n=3 Participants
|
28 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 15 monthsThe DLTs were defined as grade \>/=4 esophatitis, any other grade \>/=3 nonhematological toxicity (except nausea and vomiting), or grade \>/=4 hematological toxicity lasting more than 7 days, which are possibly, probably, or definitely associated with protocol treatment occurring during and after completion of the HFRT boost treatment.
Outcome measures
| Measure |
Arm 1: Radiochemotherapy 1
n=3 Participants
Patients will be treated with radiation therapy 57.2 Gy.
radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Arm 2: Radiochemotherapy 2
n=3 Participants
Patients will be treated with radiation therapy 64.4 Gy.
radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 2: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Arm 3：Radiochemotherapy 3
n=3 Participants
Patients will be treated with radiation therapy 71.6 Gy.
radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 3: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Arm 4: Radiochemotherapy 4
n=6 Participants
Patients will be treated with radiation therapy 78.8 Gy.
radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 4: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Arm 5: Radiochemotherapy 5
n=13 Participants
Patients will be treated with radiation therapy 86 Gy.
radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Arm 6: Radiochemotherapy 6
n=3 Participants
Patients will be treated with radiation therapy 93.2 Gy.
radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 6: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
|---|---|---|---|---|---|---|
|
Number of Dose Limiting Toxicities (DLTs) Occurring in Participants
|
0 dose limiting toxicity
|
0 dose limiting toxicity
|
0 dose limiting toxicity
|
1 dose limiting toxicity
|
0 dose limiting toxicity
|
2 dose limiting toxicity
|
SECONDARY outcome
Timeframe: 15 monthsPopulation: the patients who completed the protocol treatment
Local failure will be assessed radiographically using endoscopy with biopsy, CT scan, and a positron emission computed tomography-CT scan. which was defined as persistence /recurrence of the tumor in the radiation therapy field.
Outcome measures
| Measure |
Arm 1: Radiochemotherapy 1
n=3 Participants
Patients will be treated with radiation therapy 57.2 Gy.
radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Arm 2: Radiochemotherapy 2
n=3 Participants
Patients will be treated with radiation therapy 64.4 Gy.
radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 2: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Arm 3：Radiochemotherapy 3
n=3 Participants
Patients will be treated with radiation therapy 71.6 Gy.
radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 3: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Arm 4: Radiochemotherapy 4
n=6 Participants
Patients will be treated with radiation therapy 78.8 Gy.
radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 4: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Arm 5: Radiochemotherapy 5
n=13 Participants
Patients will be treated with radiation therapy 86 Gy.
radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
Arm 6: Radiochemotherapy 6
n=3 Participants
Patients will be treated with radiation therapy 93.2 Gy.
radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 6: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
|
|---|---|---|---|---|---|---|
|
Local Failure
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Arm 1: Radiochemotherapy 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2: Radiochemotherapy 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 3: Radiochemotherapy 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 4: Radiochemotherapy 4
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 5: Radiochemotherapy
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 6: Radiochemotherapy 6
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1: Radiochemotherapy 1
n=3 participants at risk
Patients will be treated with radiation therapy 57.2 Gy.
radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 57.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Arm 2: Radiochemotherapy 2
n=3 participants at risk
Patients will be treated with radiation therapy 64.4 Gy.
radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 2: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Arm 3: Radiochemotherapy 3
n=3 participants at risk
Patients will be treated with radiation therapy 71.6 Gy.
radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 3: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Arm 4: Radiochemotherapy 4
n=6 participants at risk
Patients will be treated with radiation therapy 78.8Gy.
radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 4: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Arm 5: Radiochemotherapy
n=13 participants at risk
Patients will be treated with radiation therapy 36 Gy.
radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 5: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Arm 6: Radiochemotherapy 6
n=3 participants at risk
Patients will be treated with radiation therapy 93.2 Gy.
radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 6: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
grade 3 pneumotitis
|
0.00%
0/3 • 15 months
|
0.00%
0/3 • 15 months
|
0.00%
0/3 • 15 months
|
0.00%
0/6 • 15 months
|
0.00%
0/13 • 15 months
|
33.3%
1/3 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
grade 5 esophageal fistula
|
0.00%
0/3 • 15 months
|
0.00%
0/3 • 15 months
|
0.00%
0/3 • 15 months
|
0.00%
0/6 • 15 months
|
0.00%
0/13 • 15 months
|
33.3%
1/3 • Number of events 1 • 15 months
|
Other adverse events
| Measure |
Arm 1: Radiochemotherapy 1
n=3 participants at risk
Patients will be treated with radiation therapy 57.2 Gy.
radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 57.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Arm 2: Radiochemotherapy 2
n=3 participants at risk
Patients will be treated with radiation therapy 64.4 Gy.
radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 2: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Arm 3: Radiochemotherapy 3
n=3 participants at risk
Patients will be treated with radiation therapy 71.6 Gy.
radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 3: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Arm 4: Radiochemotherapy 4
n=6 participants at risk
Patients will be treated with radiation therapy 78.8Gy.
radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 4: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Arm 5: Radiochemotherapy
n=13 participants at risk
Patients will be treated with radiation therapy 36 Gy.
radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 5: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
Arm 6: Radiochemotherapy 6
n=3 participants at risk
Patients will be treated with radiation therapy 93.2 Gy.
radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 6: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
3/3 • Number of events 3 • 15 months
|
100.0%
3/3 • Number of events 3 • 15 months
|
100.0%
3/3 • Number of events 3 • 15 months
|
83.3%
5/6 • Number of events 5 • 15 months
|
84.6%
11/13 • Number of events 11 • 15 months
|
33.3%
1/3 • Number of events 1 • 15 months
|
Additional Information
Dr tingfeng Chen
Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Phone: 86-021-37798364
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place