Trial Outcomes & Findings for An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS) (NCT NCT00796120)
NCT ID: NCT00796120
Last Updated: 2015-12-10
Results Overview
The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
121 participants
Primary outcome timeframe
Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months
Results posted on
2015-12-10
Participant Flow
Participant milestones
| Measure |
Trabectedin
Trabectedin 1.5 milligram per square meter (mg/m\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
|
Doxorubicin Plus Ifosfamide
Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
|
Overall Study
Treated
|
61
|
57
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
61
|
60
|
Reasons for withdrawal
| Measure |
Trabectedin
Trabectedin 1.5 milligram per square meter (mg/m\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
|
Doxorubicin Plus Ifosfamide
Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
|
|---|---|---|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Adverse Event
|
11
|
6
|
|
Overall Study
Progressive disease
|
22
|
13
|
|
Overall Study
Participant refusal
|
3
|
4
|
|
Overall Study
Other
|
6
|
17
|
|
Overall Study
Physician Decision
|
16
|
17
|
|
Overall Study
Randomized but not treated
|
0
|
3
|
Baseline Characteristics
An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)
Baseline characteristics by cohort
| Measure |
Trabectedin
n=61 Participants
Trabectedin 1.5 milligram per square meter (mg/m\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
|
Doxorubicin Plus Ifosfamide
n=60 Participants
Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>=18 to <=49 years
|
33 participants
n=93 Participants
|
30 participants
n=4 Participants
|
63 participants
n=27 Participants
|
|
Age, Customized
>=50 to <=65 years
|
19 participants
n=93 Participants
|
21 participants
n=4 Participants
|
40 participants
n=27 Participants
|
|
Age, Customized
>=65 years
|
9 participants
n=93 Participants
|
9 participants
n=4 Participants
|
18 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 monthsPopulation: Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of translocation-related sarcomas (TRS)
The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
Outcome measures
| Measure |
Trabectedin
n=51 Participants
Trabectedin 1.5 milligram per square meter (mg/m\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
|
Doxorubicin Plus Ifosfamide
n=37 Participants
Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
|
|---|---|---|
|
Progression - Free Survival (PFS)
|
19.6 months
Interval 5.7 to 32.3
|
8.3 months
Interval 7.1 to 25.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.
Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.
Outcome measures
| Measure |
Trabectedin
n=51 Participants
Trabectedin 1.5 milligram per square meter (mg/m\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
|
Doxorubicin Plus Ifosfamide
n=37 Participants
Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
|
|---|---|---|
|
6-month Progression - Free Survival
|
66.7 percentage of participants
Interval 50.6 to 82.8
|
78.3 percentage of participants
Interval 64.0 to 92.5
|
SECONDARY outcome
Timeframe: Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 monthsPopulation: Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.
Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.
Outcome measures
| Measure |
Trabectedin
n=51 Participants
Trabectedin 1.5 milligram per square meter (mg/m\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
|
Doxorubicin Plus Ifosfamide
n=37 Participants
Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
|
|---|---|---|
|
Percentage of Participants With Objective Response
|
5.9 percentage of participants
Interval 1.2 to 16.2
|
27.0 percentage of participants
Interval 13.8 to 44.1
|
SECONDARY outcome
Timeframe: Baseline up to End of Study (an average of 4 years)Population: Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.
Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.
Outcome measures
| Measure |
Trabectedin
n=51 Participants
Trabectedin 1.5 milligram per square meter (mg/m\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
|
Doxorubicin Plus Ifosfamide
n=37 Participants
Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
|
|---|---|---|
|
Overall Survival
|
46.6 months
Interval 27.5 to
Upper limit of confidence interval was not reached because of high censorship rate that is smaller number of events.
|
33.5 months
Interval 21.6 to
Upper limit of confidence interval was not reached because of high censorship rate that is smaller number of events.
|
SECONDARY outcome
Timeframe: Up to 20 monthsPopulation: Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.
Outcome measures
| Measure |
Trabectedin
n=3 Participants
Trabectedin 1.5 milligram per square meter (mg/m\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
|
Doxorubicin Plus Ifosfamide
n=10 Participants
Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
|
|---|---|---|
|
Duration of Response (DOR)
|
NA days
Interval 7.0 to
Median and upper confidence interval point estimates were not reached because of high censorship rate that is smaller number of events.
|
NA days
Interval 4.4 to
Median and upper confidence interval point estimates were not reached because of high censorship rate that is smaller number of events.
|
Adverse Events
Trabectedin
Serious events: 24 serious events
Other events: 55 other events
Deaths: 0 deaths
Doxorubicin Plus Ifosfamide
Serious events: 16 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trabectedin
n=61 participants at risk
Trabectedin 1.5 milligram per square meter (mg/m\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
|
Doxorubicin Plus Ifosfamide
n=57 participants at risk
Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
1.6%
1/61
|
0.00%
0/57
|
|
Investigations
Blood CPK increased
|
1.6%
1/61
|
0.00%
0/57
|
|
Investigations
Blood creatinine increased
|
0.00%
0/61
|
1.8%
1/57
|
|
Investigations
Liver function test abnormal
|
1.6%
1/61
|
0.00%
0/57
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/61
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/61
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.6%
1/61
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
1/61
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.6%
1/61
|
0.00%
0/57
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.6%
1/61
|
0.00%
0/57
|
|
Nervous system disorders
Dyspraxia
|
1.6%
1/61
|
0.00%
0/57
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/61
|
1.8%
1/57
|
|
Psychiatric disorders
Mental disorder
|
1.6%
1/61
|
1.8%
1/57
|
|
Renal and urinary disorders
Renal impairment
|
1.6%
1/61
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
1/61
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/61
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/61
|
0.00%
0/57
|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
2/61
|
0.00%
0/57
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
3.3%
2/61
|
0.00%
0/57
|
|
General disorders
Injection site extravasation
|
4.9%
3/61
|
0.00%
0/57
|
|
General disorders
Pain
|
3.3%
2/61
|
0.00%
0/57
|
|
General disorders
Pyrexia
|
4.9%
3/61
|
3.5%
2/57
|
|
Hepatobiliary disorders
Liver injury
|
1.6%
1/61
|
0.00%
0/57
|
|
Hepatobiliary disorders
Hepatocellular injury
|
1.6%
1/61
|
0.00%
0/57
|
|
Infections and infestations
Bacteremia
|
1.6%
1/61
|
0.00%
0/57
|
|
Infections and infestations
Bronchitis viral
|
1.6%
1/61
|
0.00%
0/57
|
|
Infections and infestations
Catheter related infection
|
6.6%
4/61
|
0.00%
0/57
|
|
Infections and infestations
Device related infection
|
4.9%
3/61
|
0.00%
0/57
|
|
Infections and infestations
Erysipelas
|
1.6%
1/61
|
0.00%
0/57
|
|
Infections and infestations
Infusion site infection
|
1.6%
1/61
|
0.00%
0/57
|
|
Infections and infestations
Lower respiratory tract infection
|
1.6%
1/61
|
0.00%
0/57
|
|
Infections and infestations
Pneumococcal bacteremia
|
0.00%
0/61
|
1.8%
1/57
|
|
Infections and infestations
Pneumonia
|
1.6%
1/61
|
3.5%
2/57
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
1/61
|
0.00%
0/57
|
|
Infections and infestations
Rhinitis
|
0.00%
0/61
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
2/61
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
1/61
|
12.3%
7/57
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/61
|
1.8%
1/57
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.3%
2/61
|
3.5%
2/57
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.3%
2/61
|
1.8%
1/57
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/61
|
5.3%
3/57
|
|
Gastrointestinal disorders
Duodenal perforation
|
1.6%
1/61
|
0.00%
0/57
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/61
|
0.00%
0/57
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
2/61
|
0.00%
0/57
|
|
General disorders
Chest discomfort
|
1.6%
1/61
|
0.00%
0/57
|
|
General disorders
Chest pain
|
0.00%
0/61
|
1.8%
1/57
|
|
General disorders
Drug withdrawal syndrome
|
1.6%
1/61
|
0.00%
0/57
|
|
General disorders
Fatigue
|
0.00%
0/61
|
1.8%
1/57
|
|
General disorders
Hypothermia
|
1.6%
1/61
|
0.00%
0/57
|
Other adverse events
| Measure |
Trabectedin
n=61 participants at risk
Trabectedin 1.5 milligram per square meter (mg/m\^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
|
Doxorubicin Plus Ifosfamide
n=57 participants at risk
Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.0%
11/61
|
22.8%
13/57
|
|
Blood and lymphatic system disorders
Neutropenia
|
47.5%
29/61
|
26.3%
15/57
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.8%
9/61
|
3.5%
2/57
|
|
Cardiac disorders
Tachycardia
|
4.9%
3/61
|
7.0%
4/57
|
|
Eye disorders
Eye irritation
|
0.00%
0/61
|
5.3%
3/57
|
|
Gastrointestinal disorders
Abdominal distension
|
6.6%
4/61
|
3.5%
2/57
|
|
Gastrointestinal disorders
Abdominal pain
|
13.1%
8/61
|
12.3%
7/57
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.1%
8/61
|
8.8%
5/57
|
|
Gastrointestinal disorders
Constipation
|
44.3%
27/61
|
28.1%
16/57
|
|
Gastrointestinal disorders
Diarrhoea
|
24.6%
15/61
|
26.3%
15/57
|
|
Gastrointestinal disorders
Dry mouth
|
3.3%
2/61
|
5.3%
3/57
|
|
Gastrointestinal disorders
Dyspepsia
|
13.1%
8/61
|
12.3%
7/57
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.6%
1/61
|
7.0%
4/57
|
|
Gastrointestinal disorders
Nausea
|
75.4%
46/61
|
70.2%
40/57
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/61
|
17.5%
10/57
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
1/61
|
10.5%
6/57
|
|
Gastrointestinal disorders
Vomiting
|
47.5%
29/61
|
28.1%
16/57
|
|
General disorders
Chest pain
|
4.9%
3/61
|
5.3%
3/57
|
|
General disorders
Fatigue
|
73.8%
45/61
|
73.7%
42/57
|
|
General disorders
Mass
|
16.4%
10/61
|
8.8%
5/57
|
|
General disorders
Mucosal inflammation
|
6.6%
4/61
|
26.3%
15/57
|
|
General disorders
Oedema peripheral
|
29.5%
18/61
|
10.5%
6/57
|
|
General disorders
Pain
|
3.3%
2/61
|
5.3%
3/57
|
|
General disorders
Pyrexia
|
16.4%
10/61
|
19.3%
11/57
|
|
Infections and infestations
Candidiasis
|
0.00%
0/61
|
5.3%
3/57
|
|
Infections and infestations
Catheter related infection
|
6.6%
4/61
|
0.00%
0/57
|
|
Infections and infestations
Urinary tract infection
|
3.3%
2/61
|
5.3%
3/57
|
|
Investigations
Alanine aminotransferase increased
|
31.1%
19/61
|
1.8%
1/57
|
|
Investigations
Aspartate aminotransferase increased
|
14.8%
9/61
|
0.00%
0/57
|
|
Investigations
Blood alkaline phosphataseincreased
|
9.8%
6/61
|
0.00%
0/57
|
|
Investigations
Blood creatine phosphokinase increased
|
6.6%
4/61
|
1.8%
1/57
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.8%
6/61
|
0.00%
0/57
|
|
Investigations
Weight decreased
|
6.6%
4/61
|
14.0%
8/57
|
|
Metabolism and nutrition disorders
Anorexia
|
32.8%
20/61
|
26.3%
15/57
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
3/61
|
7.0%
4/57
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.9%
3/61
|
7.0%
4/57
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.3%
2/61
|
7.0%
4/57
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
5/61
|
12.3%
7/57
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.1%
8/61
|
15.8%
9/57
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
6.6%
4/61
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
2/61
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.6%
4/61
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.5%
7/61
|
3.5%
2/57
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
6/61
|
5.3%
3/57
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
55.7%
34/61
|
57.9%
33/57
|
|
Nervous system disorders
Dizziness
|
8.2%
5/61
|
12.3%
7/57
|
|
Nervous system disorders
Dysgeusia
|
6.6%
4/61
|
10.5%
6/57
|
|
Nervous system disorders
Headache
|
21.3%
13/61
|
24.6%
14/57
|
|
Nervous system disorders
Neuropathy peripheral
|
6.6%
4/61
|
0.00%
0/57
|
|
Nervous system disorders
Paraesthesia
|
3.3%
2/61
|
5.3%
3/57
|
|
Nervous system disorders
Tremor
|
1.6%
1/61
|
5.3%
3/57
|
|
Psychiatric disorders
Anxiety
|
9.8%
6/61
|
7.0%
4/57
|
|
Psychiatric disorders
Insomnia
|
19.7%
12/61
|
10.5%
6/57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.4%
10/61
|
17.5%
10/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.7%
12/61
|
10.5%
6/57
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/61
|
7.0%
4/57
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.2%
5/61
|
3.5%
2/57
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/61
|
5.3%
3/57
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
2/61
|
43.9%
25/57
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.6%
4/61
|
10.5%
6/57
|
|
Skin and subcutaneous tissue disorders
Scar
|
6.6%
4/61
|
3.5%
2/57
|
|
Vascular disorders
Deep vein thrombosis
|
6.6%
4/61
|
0.00%
0/57
|
|
Vascular disorders
Hypertension
|
11.5%
7/61
|
0.00%
0/57
|
|
Vascular disorders
Hypotension
|
3.3%
2/61
|
5.3%
3/57
|
Additional Information
Medical Specialist, Clinical Oncology
PharmaMar SA Av de los Reyes 1, Poligono Industrial La Mina 28770 Colmenar Viejo, Madrid, Spain
Phone: +34 91 646-6087
Results disclosure agreements
- Principal investigator is a sponsor employee Before Investigators of this study publicly disclose information, PharmaMar must be provided with at least 60 days to review and approve disclosure in order to ensure that confidential and proprietary data are protected. If PharmaMar determines that patentable patient matter is disclosed in the proposed disclosure, the latter shall be withheld for period of time considered convenient.
- Publication restrictions are in place
Restriction type: OTHER