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FOLFIRINOX + RT for Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01591733
Recruitment Status : Completed
First Posted : May 4, 2012
Results First Posted : April 30, 2018
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: FOLFIRINOX
Drug: Capecitabine
Radiation: Short Course Radiation
Procedure: Surgery
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FOLFIRINOX + Radiation
Hide Arm/Group Description

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

FOLFIRINOX: Up to Eight-14 day cycles

Capecitabine: Orally, for 10 days

Short Course Radiation: Five or ten days

Surgery: 1-4 weeks after completion of capecitabine therapy

Period Title: Overall Study
Started 48
Completed 48
Not Completed 0
Arm/Group Title FOLFIRINOX + Radiation
Hide Arm/Group Description

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

FOLFIRINOX: Up to Eight-14 day cycles

Capecitabine: Orally, for 10 days

Short Course Radiation: Five or ten days

Surgery: 1-4 weeks after completion of capecitabine therapy

Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 48 participants
62
(46 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
21
  43.8%
Male
27
  56.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Hispanic or Latino
1
   2.1%
Not Hispanic or Latino
46
  95.8%
Unknown or Not Reported
1
   2.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 48 participants
48
 100.0%
CA19-9 Level   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<35 U/ml (Normal)
12
  25.0%
≥35 U/ml (elevated)
36
  75.0%
[1]
Measure Description: Cancer antigen 19-9 (CA 19-9) level
CEA Level   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<3.4 ng/ml (normal)
23
  47.9%
≥3.4 ng/ml (elevated)
25
  52.1%
[1]
Measure Description: Carcinoembryonic antigen level
Pancreatic Tumor Site  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Head
35
  72.9%
Body
11
  22.9%
Tail
2
   4.2%
Tumor Size  
Median (Full Range)
Unit of measure:  Centimeters (cm)
Number Analyzed 48 participants
3.75
(2.1 to 5.6)
Vessel Involvement  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Venous
28
  58.3%
Arterial
7
  14.6%
Both
12
  25.0%
None
1
   2.1%
1.Primary Outcome
Title Rate of R0 Resection
Time Frame Post-surgery (about 4 months post baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Eligible - FOLFIRINOX + Radiation Resected Participants - FOLFIRINOX + Radiation
Hide Arm/Group Description:

The overall study population

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

FOLFIRINOX: Up to Eight-14 day cycles

Capecitabine: Orally, for 10 days

Short Course Radiation: Five or ten days

Surgery: 1-4 weeks after completion of capecitabine therapy

The participants that were resected.

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

FOLFIRINOX: Up to Eight-14 day cycles

Capecitabine: Orally, for 10 days

Short Course Radiation: Five or ten days

Surgery: 1-4 weeks after completion of capecitabine therapy

Overall Number of Participants Analyzed 48 32
Measure Type: Count of Participants
Unit of Measure: Participants
31
  64.6%
31
  96.9%
2.Secondary Outcome
Title Median Progression-Free Survival
Hide Description The median progression free survival as measured from the start of treatment until the time of disease progression or death, whichever occurs first. Disease status was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Disease progression is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesion, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame From the start of treatment until death or disease progression, median duration of follow-up of 14.7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOLFIRINOX + Radiation
Hide Arm/Group Description:

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

FOLFIRINOX: Up to Eight-14 day cycles

Capecitabine: Orally, for 10 days

Short Course Radiation: Five or ten days

Surgery: 1-4 weeks after completion of capecitabine therapy

Overall Number of Participants Analyzed 48
Median (95% Confidence Interval)
Unit of Measure: Months
14.7 [1] 
(10.5 to NA)
[1]
Upper bound is not defined due to skewed survival data (participants still surviving).
3.Secondary Outcome
Title Median Overall Survival
Hide Description Median overall survival, as measured from the start of treatment until the time of death.
Time Frame From the start of treatment until the time of death, median duration of follow-up of 37.7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOLFIRINOX + Radiation
Hide Arm/Group Description:

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

FOLFIRINOX: Up to Eight-14 day cycles

Capecitabine: Orally, for 10 days

Short Course Radiation: Five or ten days

Surgery: 1-4 weeks after completion of capecitabine therapy

Overall Number of Participants Analyzed 48
Median (95% Confidence Interval)
Unit of Measure: Months
37.7 [1] 
(19.4 to NA)
[1]
Upper bound is not defined due to skewed survival data (participants still surviving).
4.Secondary Outcome
Title Preoperative Toxicity of Grade 3 or Worse Related to FOLFIRINOX and Chemoradiation
Hide Description Frequency of grade 3 or greater adverse events deemed related to FOLFIRINOX+short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
Time Frame From the start of treatment until the end of chemoradiation, about 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOLFIRINOX + Radiation
Hide Arm/Group Description:

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

FOLFIRINOX: Up to Eight-14 day cycles

Capecitabine: Orally, for 10 days

Short Course Radiation: Five or ten days

Surgery: 1-4 weeks after completion of capecitabine therapy

Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
Diarrhea
5
  10.4%
Neutropenia
2
   4.2%
Febrile neutropenia
1
   2.1%
Lymphopenia
1
   2.1%
Thrombocytopenia
1
   2.1%
Anemia
1
   2.1%
Elevated alkaline phosphatase
1
   2.1%
Elevated bilirubin
1
   2.1%
Elevated AST/ALT
1
   2.1%
Peripheral neuropathy
2
   4.2%
Abdominal pain
1
   2.1%
Constipation
1
   2.1%
5.Secondary Outcome
Title The Proportion of Participants With Surgery Related Adverse Events
Hide Description The number of participants with surgery related any grade adverse events following pancreaticoduodenectomy or distal pancreatectomy after receiving preoperative FOLFIRINOX and preoperative short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
Time Frame At the time of surgery, 30 days post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The participants that underwent surgery
Arm/Group Title FOLFIRINOX + Radiation
Hide Arm/Group Description:

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

FOLFIRINOX: Up to Eight-14 day cycles

Capecitabine: Orally, for 10 days

Short Course Radiation: Five or ten days

Surgery: 1-4 weeks after completion of capecitabine therapy

Overall Number of Participants Analyzed 32
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
0.375
(0.233 to 0.536)
6.Secondary Outcome
Title 30 Day Post-operative Mortality Rate
Hide Description The number of participants that died within 30 days after undergoing pancreaticoduodenectomy or distal pancreatectomy.
Time Frame 30 days post surgery (about 6 months from baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants that underwent surgery
Arm/Group Title FOLFIRINOX + Radiation
Hide Arm/Group Description:

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

FOLFIRINOX: Up to Eight-14 day cycles

Capecitabine: Orally, for 10 days

Short Course Radiation: Five or ten days

Surgery: 1-4 weeks after completion of capecitabine therapy

Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Secondary Outcome
Title Rate of Pathologic Downstaging
Hide Description To determine the rate of pathologic down-staging among participants that underwent pancreaticoduodenectomy or distal pancreatectomy. The pathologic downstaging rate is the proportion of patients with the primary tumor and nodes downstaged based on final pathology of the surgical specimen.
Time Frame Baseline, Post surgery
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Local Control Rates
Hide Description The number of participants that achieved local control. Local control was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Local Failure is defined as progression of the primary tumor, or to the reappearance of tumor at the primary site.
Time Frame From the start of treatment until the end of treatment with FOLFIRINOX, or until disease progression (median duration of follow-up of approximately 14 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The first 5 participants treated who only received 4 cycles of FOLFIRINOX instead of 8 were not included in the analysis of local control.
Arm/Group Title FOLFIRINOX + Radiation
Hide Arm/Group Description:

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

FOLFIRINOX: Up to Eight-14 day cycles

Capecitabine: Orally, for 10 days

Short Course Radiation: Five or ten days

Surgery: 1-4 weeks after completion of capecitabine therapy

Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
32
  74.4%
9.Secondary Outcome
Title Correlation of Mutational Analysis Biomarkers
Hide Description To correlate mutational analysis biomarkers (SNaPSHOT assay) with response to treatment
Time Frame 2 years
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Quality of Life, Symptom Burden, and Mood
Hide Description Patient-reported outcomes: We will use descriptive statistics to describe Quality of Life (QOL) (EORTC QLQ-C30), symptom burden (ESAS-r) and mood (HADS) for the entire study cohort.
Time Frame 2 years
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Utilization of Health Services (Emergency Room, Hospital and Intensive Care Unit)
Hide Description Summary of the number of hospitalizations, intensive care unit (ICU) stays, emergency department (ED) stays, and palliative care use for the study population.
Time Frame 2 years
Outcome Measure Data Not Reported
Time Frame From the start of treatment until 30 days after the end of treatment, about 6 months. Treatment is continued until disease progression, intercurrent illness that prevents further treatment, unacceptable adverse events, participant withdrawal, or until the treating investigator decides it is in the participants best interest.
Adverse Event Reporting Description Adverse events were defined as any grade 3 or greater toxicity deemed to be possibly, probably, or definitely related to treatment
 
Arm/Group Title FOLFIRINOX + Radiation
Hide Arm/Group Description

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

FOLFIRINOX: Up to Eight-14 day cycles

Capecitabine: Orally, for 10 days

Short Course Radiation: Five or ten days

Surgery: 1-4 weeks after completion of capecitabine therapy

All-Cause Mortality
FOLFIRINOX + Radiation
Affected / at Risk (%)
Total   2/48 (4.17%)    
Show Serious Adverse Events Hide Serious Adverse Events
FOLFIRINOX + Radiation
Affected / at Risk (%) # Events
Total   24/48 (50.00%)    
Blood and lymphatic system disorders   
Anemia  1  3/48 (6.25%)  4
Febrile neutropenia  1  3/48 (6.25%)  4
Gastrointestinal disorders   
Abdominal pain  1  1/48 (2.08%)  2
Constipation  1  1/48 (2.08%)  1
Diarrhea  1  7/48 (14.58%)  11
Nausea  1  1/48 (2.08%)  1
General disorders   
Fatigue  1  2/48 (4.17%)  2
Fever  1  1/48 (2.08%)  1
Immune system disorders   
Anaphylaxis  1  1/48 (2.08%)  1
Investigations   
Alanine aminotransferase increased  1  2/48 (4.17%)  4
Alkaline phosphatase increased  1  2/48 (4.17%)  4
Aspartate aminotransferase increased  1  3/48 (6.25%)  4
Blood bilirubin increased  1  1/48 (2.08%)  1
Lymphocyte count decreased  1  1/48 (2.08%)  1
Neutrophil count decreased  1  7/48 (14.58%)  11
Platelet count decreased  1  2/48 (4.17%)  4
Weight loss  1  2/48 (4.17%)  2
White blood cell decreased  1  1/48 (2.08%)  1
Metabolism and nutrition disorders   
Anorexia  1  3/48 (6.25%)  3
Hypokalemia  1  1/48 (2.08%)  1
Nervous system disorders   
Peripheral sensory neuropathy  1  2/48 (4.17%)  2
Vascular disorders   
Hot flashes  1  1/48 (2.08%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FOLFIRINOX + Radiation
Affected / at Risk (%) # Events
Total   48/48 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  7/48 (14.58%)  14
Cardiac disorders   
Atrial fibrillation  1  4/48 (8.33%)  6
Cardiac disorders - Other  1  9/48 (18.75%)  17
Palpitations  1  6/48 (12.50%)  9
Sinus tachycardia  1  7/48 (14.58%)  8
Supraventricular tachycardia  1  4/48 (8.33%)  4
Eye disorders   
Blurred vision  1  5/48 (10.42%)  10
Dry eye  1  3/48 (6.25%)  6
Eye disorders - Other  1  7/48 (14.58%)  11
Eye pain  1  3/48 (6.25%)  6
Watering eyes  1  3/48 (6.25%)  5
Gastrointestinal disorders   
Abdominal distension  1  18/48 (37.50%)  38
Abdominal pain  1  44/48 (91.67%)  187
Ascites  1  6/48 (12.50%)  8
Bloating  1  16/48 (33.33%)  33
Constipation  1  40/48 (83.33%)  114
Diarrhea  1  43/48 (89.58%)  201
Dry mouth  1  11/48 (22.92%)  15
Dyspepsia  1  12/48 (25.00%)  20
Dysphagia  1  5/48 (10.42%)  5
Enterocolitis  1  4/48 (8.33%)  5
Fecal incontinence  1  5/48 (10.42%)  7
Flatulence  1  20/48 (41.67%)  57
Gastroesophageal reflux disease  1  17/48 (35.42%)  28
Gastrointestinal disorders - Other  1  26/48 (54.17%)  54
Gastroparesis  1  4/48 (8.33%)  8
Hemorrhoids  1  4/48 (8.33%)  5
Malabsorption  1  13/48 (27.08%)  20
Mucositis oral  1  20/48 (41.67%)  36
Nausea  1  46/48 (95.83%)  217
Oral pain  1  3/48 (6.25%)  3
Pancreatitis  1  3/48 (6.25%)  3
Rectal pain  1  3/48 (6.25%)  7
Small intestinal obstruction  1  3/48 (6.25%)  3
Toothache  1  3/48 (6.25%)  4
Vomiting  1  30/48 (62.50%)  73
General disorders   
Chills  1  16/48 (33.33%)  21
Edema face  1  4/48 (8.33%)  4
Edema limbs  1  18/48 (37.50%)  51
Facial pain  1  3/48 (6.25%)  4
Fatigue  1  48/48 (100.00%)  258
Fever  1  28/48 (58.33%)  44
Gait disturbance  1  8/48 (16.67%)  14
General disorders and administration site conditions - Other  1  11/48 (22.92%)  39
Malaise  1  7/48 (14.58%)  13
Non-cardiac chest pain  1  5/48 (10.42%)  9
Pain  1  7/48 (14.58%)  10
Hepatobiliary disorders   
Hepatobiliary disorders - Other  1  10/48 (20.83%)  28
Immune system disorders   
Allergic reaction  1  4/48 (8.33%)  14
Infections and infestations   
Biliary tract infection  1  6/48 (12.50%)  7
Infections and infestations - Other  1  10/48 (20.83%)  16
Mucosal infection  1  3/48 (6.25%)  5
Sepsis  1  3/48 (6.25%)  4
Skin infection  1  5/48 (10.42%)  7
Upper respiratory infection  1  8/48 (16.67%)  11
Urinary tract infection  1  7/48 (14.58%)  16
Injury, poisoning and procedural complications   
Bruising  1  10/48 (20.83%)  15
Fall  1  5/48 (10.42%)  7
Injury, poisoning and procedural complications - Other  1  4/48 (8.33%)  4
Wound complication  1  3/48 (6.25%)  5
Wound dehiscence  1  4/48 (8.33%)  7
Investigations   
Alanine aminotransferase increased  1  20/48 (41.67%)  43
Alkaline phosphatase increased  1  6/48 (12.50%)  12
Aspartate aminotransferase increased  1  10/48 (20.83%)  33
Blood bilirubin increased  1  16/48 (33.33%)  31
Cholesterol high  1  4/48 (8.33%)  4
Neutrophil count decreased  1  6/48 (12.50%)  10
Pancreatic enzymes decreased  1  6/48 (12.50%)  11
Platelet count decreased  1  11/48 (22.92%)  21
Weight gain  1  3/48 (6.25%)  5
Weight loss  1  41/48 (85.42%)  163
Metabolism and nutrition disorders   
Anorexia  1  45/48 (93.75%)  163
Dehydration  1  25/48 (52.08%)  69
Hyperglycemia  1  6/48 (12.50%)  6
Hyperkalemia  1  5/48 (10.42%)  6
Hypokalemia  1  20/48 (41.67%)  92
Hyponatremia  1  7/48 (14.58%)  9
Metabolism and nutrition disorders - Other  1  4/48 (8.33%)  4
Musculoskeletal and connective tissue disorders   
Arthralgia  1  10/48 (20.83%)  17
Arthritis  1  4/48 (8.33%)  4
Back pain  1  27/48 (56.25%)  72
Bone pain  1  12/48 (25.00%)  22
Chest wall pain  1  6/48 (12.50%)  8
Flank pain  1  3/48 (6.25%)  3
Generalized muscle weakness  1  9/48 (18.75%)  28
Muscle weakness lower limb  1  3/48 (6.25%)  4
Musculoskeletal and connective tissue disorder - Other  1  8/48 (16.67%)  12
Myalgia  1  9/48 (18.75%)  18
Neck pain  1  3/48 (6.25%)  3
Pain in extremity  1  11/48 (22.92%)  18
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other  1  5/48 (10.42%)  7
Nervous system disorders   
Cognitive disturbance  1  3/48 (6.25%)  3
Concentration impairment  1  3/48 (6.25%)  4
Dizziness  1  24/48 (50.00%)  55
Dysarthria  1  5/48 (10.42%)  9
Dysesthesia  1  3/48 (6.25%)  4
Dysgeusia  1  25/48 (52.08%)  36
Headache  1  14/48 (29.17%)  31
Lethargy  1  3/48 (6.25%)  3
Memory impairment  1  4/48 (8.33%)  4
Nervous system disorders - Other  1  7/48 (14.58%)  13
Paresthesia  1  9/48 (18.75%)  14
Peripheral motor neuropathy  1  4/48 (8.33%)  6
Peripheral sensory neuropathy  1  46/48 (95.83%)  243
Somnolence  1  3/48 (6.25%)  3
Spasticity  1  8/48 (16.67%)  19
Tremor  1  3/48 (6.25%)  7
Psychiatric disorders   
Anxiety  1  26/48 (54.17%)  70
Confusion  1  5/48 (10.42%)  5
Depression  1  15/48 (31.25%)  28
Hallucinations  1  3/48 (6.25%)  4
Insomnia  1  32/48 (66.67%)  78
Renal and urinary disorders   
Renal and urinary disorders - Other  1  5/48 (10.42%)  7
Urinary frequency  1  10/48 (20.83%)  20
Urinary incontinence  1  4/48 (8.33%)  8
Urinary tract pain  1  3/48 (6.25%)  5
Urinary urgency  1  5/48 (10.42%)  6
Urine discoloration  1  8/48 (16.67%)  12
Reproductive system and breast disorders   
Reproductive system and breast disorders - Other  1  3/48 (6.25%)  4
Respiratory, thoracic and mediastinal disorders   
Cough  1  15/48 (31.25%)  34
Dyspnea  1  14/48 (29.17%)  33
Epistaxis  1  11/48 (22.92%)  19
Hiccups  1  7/48 (14.58%)  11
Hypoxia  1  4/48 (8.33%)  4
Nasal congestion  1  4/48 (8.33%)  7
Pleural effusion  1  5/48 (10.42%)  8
Postnasal drip  1  4/48 (8.33%)  4
Productive cough  1  3/48 (6.25%)  4
Respiratory, thoracic and mediastinal disorders - Other  1  11/48 (22.92%)  15
Sore throat  1  9/48 (18.75%)  18
Wheezing  1  4/48 (8.33%)  8
Skin and subcutaneous tissue disorders   
Alopecia  1  19/48 (39.58%)  55
Dry skin  1  8/48 (16.67%)  16
Hyperhidrosis  1  5/48 (10.42%)  7
Pain of skin  1  4/48 (8.33%)  4
Palmar-plantar erythrodysesthesia syndrome  1  5/48 (10.42%)  8
Pruritus  1  11/48 (22.92%)  14
Skin and subcutaneous tissue disorders - Other  1  23/48 (47.92%)  51
Vascular disorders   
Flushing  1  3/48 (6.25%)  4
Hypertension  1  13/48 (27.08%)  19
Hypotension  1  16/48 (33.33%)  26
Thromboembolic event  1  5/48 (10.42%)  5
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Theodore Hong
Organization: Massachusetts General Hospital
Phone: 617-726-6050
EMail: TSHONG1@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Theodore Sunki Hong, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01591733     History of Changes
Other Study ID Numbers: 11-328
First Submitted: April 20, 2012
First Posted: May 4, 2012
Results First Submitted: March 2, 2018
Results First Posted: April 30, 2018
Last Update Posted: February 6, 2019