Radiation Therapy Plus Chemotherapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum

Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00006366
Collaborator
National Cancer Institute (NCI) (NIH)
235

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of radiation therapy plus chemotherapy is more effective for rectal cancer.

PURPOSE: Randomized phase II trial to compare two regimens of radiation therapy plus chemotherapy followed by surgery in treating patients who have locally advanced cancer of the rectum.

Condition or Disease Intervention/Treatment Phase
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Procedure: conventional surgery
  • Radiation: radiation therapy
Phase 2

Detailed Description

OBJECTIVES:
  • Compare the pathological complete response, acute and late normal tissue morbidity, patterns of failure, and complete resection rates in patients with locally advanced adenocarcinoma of the distal rectum treated with neoadjuvant chemoradiotherapy comprised of hyperfractionated radiotherapy and fluorouracil vs conventional radiotherapy, fluorouracil, and irinotecan, followed by radical resection.

OUTLINE: This is a randomized study. Patients are stratified according to clinical stage (T3 vs T4). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive hyperfractionated radiotherapy (RT) twice daily, 5 days a week for 19 days. Patients receive fluorouracil IV continuously over 7 days a week concurrently with RT. Patients with clinical stage T3 or fixed T4 disease also receive a higher boost dose of RT to tumor.

  • Arm II: Patients receive conventional RT once daily, 5 days a week for 25 days. Patients receive fluorouracil IV continuously over 5 days a week concurrently with RT. Patients receive irinotecan IV over 1 hour (immediately prior to RT dose) once weekly for 4 weeks. Patients with clinical stage T3 or fixed T4 disease also receive a lower boost dose of RT to tumor.

Within 4-10 weeks after completion of chemoradiotherapy, patients on both arms undergo radical anterior resection or radical abdominal perineal resection with preferably a total mesorectal resection.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study within 18 months.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
Randomized Phase II Trial of Preoperative Combined Modality Chemoradiation for Distal Rectal Cancer
Study Start Date :
Feb 1, 2001
Actual Primary Completion Date :
Dec 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:
    • Histologically confirmed adenocarcinoma of the distal rectum

    • Located 0-9 cm from the dentate line (3-12 cm from the anal verge)

    • No extension of malignant disease into the anal canal

    • Lesions may be mobile stage T3 by endorectal ultrasound OR fixed, defined as clinical stage T4, by palpation

    • No evidence of distant metastases

    PATIENT CHARACTERISTICS:
    Age:
    • Over 18
    Performance status:
    • Zubrod 0-1
    Life expectancy:
    • Not specified
    Hematopoietic:
    • WBC (white blood cell count) greater than 4,000/mm^3

    • Platelet count greater than 130,000/mm^3

    Hepatic:
    • Bilirubin no greater than 1.5 times upper limit of normal

    • Alkaline phosphatase, SGOT (serum glutamic oxaloacetic transaminase), and LDH (lactate dehydrogenase) normal

    Renal:
    • Creatinine normal
    Other:
    • Not pregnant or nursing

    • Fertile patients must use effective contraception

    • No other invasive malignancy within the past 5 years except:

    • Inactive nonmelanomatous skin cancer

    • Carcinoma in situ of the cervix

    • Synchronous colonic cancer if tumor is Tis or T1 and has been completely resected

    • No other serious medical illnesses

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:
    • No prior chemotherapy
    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • No prior radiotherapy to pelvis
    Surgery:
    • Not specified
    Other:
    • No concurrent antiepileptic drugs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294-3300
    2 Comprehensive Cancer Institute of Huntsville Huntsville Alabama United States 35801
    3 Huntsville Hospital System Huntsville Alabama United States 35807
    4 MBCCOP - Gulf Coast Mobile Alabama United States 36688
    5 Alabama Oncology, LLC Montgomery Alabama United States 36106-3657
    6 Radiation Oncology Associates of West Alabama Tuscaloosa Alabama United States 35401
    7 Foundation for Cancer Research and Education Phoenix Arizona United States 85013
    8 Mount Diablo Medical Center Concord California United States 94524-4110
    9 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    10 Saint Agnes Cancer Center Fresno California United States 93720
    11 California Cancer Center Fresno California United States 93729-5100
    12 Sutter Health West Cancer Research Group Greenbrae California United States 94904
    13 Loma Linda University Medical Center Loma Linda California United States 92354
    14 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
    15 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90025-1781
    16 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
    17 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    18 Huntington Cancer Center Pasadena California United States 91105
    19 Cancer Care Center Pomona California United States 91767
    20 Radiation Oncology Center - Sacramento Sacramento California United States 95816
    21 Radiation Medical Group, Inc. San Diego California United States 92101
    22 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
    23 O'Connor Hospital San Jose California United States 95128
    24 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    25 David Grant Medical Center Travis Air Force Base California United States 94535
    26 Memorial Hospital Cancer Center Colorado Springs Colorado United States 80909
    27 University of Colorado Cancer Center Denver Colorado United States 80010
    28 Saint Mary's Hospital and Medical Center Grand Junction Colorado United States 81502-1628
    29 Hospital of St. Raphael New Haven Connecticut United States 06511
    30 CCOP - Christiana Care Health Services Wilmington Delaware United States 19899
    31 University of Florida Health Science Center Gainesville Florida United States 32610-0385
    32 Florida Radiation Oncology Group Jacksonville Florida United States 32207
    33 Health First Holmes Regional Medical Center Melbourne Florida United States 32901-3276
    34 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
    35 Veterans Affairs Medical Center - Miami Miami Florida United States 33125
    36 Sylvester Cancer Center, University of Miami Miami Florida United States 33136
    37 Baptist Hospital of Miami Miami Florida United States 33256-2110
    38 MD Anderson Cancer Center Orlando Orlando Florida United States 32806
    39 Bay Medical Center Panama City Florida United States 32401
    40 Gulf Coast Cancer Treatment Center Panama City Florida United States 32405-4587
    41 Sarasota Radiation and Medical Oncology Center Sarasota Florida United States 34233
    42 Tallahassee Memorial Healthcare Tallahassee Florida United States 32308
    43 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
    44 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    45 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    46 Medical Center/John B. Amos Community Cancer Center Columbus Georgia United States 31901
    47 Regional Radiation Oncology Center at Rome Rome Georgia United States 30165
    48 MBCCOP - Hawaii Honolulu Hawaii United States 96813
    49 Northwest Community Hospital Arlington Heights Illinois United States 60005
    50 Northwestern Memorial Hospital Chicago Illinois United States 60611
    51 CCOP - Central Illinois Decatur Illinois United States 62526
    52 Ingalls Memorial Hospital Harvey Illinois United States 60426
    53 Loyola University Medical Center Maywood Illinois United States 60153
    54 Lutheran General Cancer Care Center Park Ridge Illinois United States 60068
    55 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    56 St. John's Medical Center Anderson Indiana United States 46016
    57 Bloomington Hospital Bloomington Indiana United States 47402
    58 Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana United States 46202
    59 Clarian Health Partners Inc. Indianapolis Indiana United States 46206-1367
    60 Regional Cancer Center Indianapolis Indiana United States 46219
    61 Ball Memorial Hospital Muncie Indiana United States 47303-3499
    62 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
    63 Wendt Regional Cancer Center of Finley Hospital Dubuque Iowa United States 52001
    64 Central Baptist Hospital Lexington Kentucky United States 40503
    65 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0293
    66 James Graham Brown Cancer Center Louisville Kentucky United States 40202
    67 Louisville Radiation Oncology Louisville Kentucky United States 40215
    68 Merle M. Mahr Cancer Center Madisonville Kentucky United States 42431
    69 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    70 Tulane University School of Medicine New Orleans Louisiana United States 70112-2699
    71 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    72 CCOP - Ochsner New Orleans Louisiana United States 70121
    73 Maine Medical Center Portland Maine United States 04102
    74 Anne Arundel Oncology Center Annapolis Maryland United States 21401
    75 Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201
    76 Greater Baltimore Medical Center and Cancer Center Baltimore Maryland United States 21204
    77 Harbor Hospital Center Baltimore Maryland United States 21215-1290
    78 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    79 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    80 Peninsula Regional Medical Center Salisbury Maryland United States 21801
    81 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    82 Cape Cod Hospital Hyannis Massachusetts United States 02601
    83 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
    84 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    85 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
    86 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    87 Henry Ford Hospital Detroit Michigan United States 48202
    88 Hurley Medical Center Flint Michigan United States 48503
    89 McLaren Regional Cancer Center Flint Michigan United States 48532-3685
    90 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    91 Marquette General Hospital Marquette Michigan United States 49855
    92 MidMichigan Medical Center - Midland Midland Michigan United States 48670
    93 CCOP - Beaumont Royal Oak Michigan United States 48073-6769
    94 William Beaumont Hospital Royal Oak Michigan United States 48073
    95 William Beaumont Hospital - Troy Troy Michigan United States 48098
    96 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    97 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    98 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    99 CCOP - Kansas City Kansas City Missouri United States 64131
    100 Mallinckrodt Institute of Radiology Saint Louis Missouri United States 63108
    101 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
    102 Cancer Research for the Ozarks Springfield Missouri United States 65807
    103 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    104 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    105 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
    106 Methodist Cancer Center - Omaha Omaha Nebraska United States 68114
    107 Nebraska Health System Omaha Nebraska United States 68198-7460
    108 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    109 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002
    110 Elliot Regional Cancer Center Manchester New Hampshire United States 03103
    111 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07019
    112 John F. Kennedy Medical Center Edison New Jersey United States 08818
    113 Trinitas Hospital - Jersey Street Campus Elizabeth New Jersey United States 07201
    114 Monmouth Medical Center Long Branch New Jersey United States 07740-6395
    115 South Jersey Regional Cancer Center Millville New Jersey United States 08332
    116 Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County Mount Holly New Jersey United States 08060
    117 Cancer Institute of New Jersey New Brunswick New Jersey United States 38103-2807
    118 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    119 Atlantic City Medical Center Pomona New Jersey United States 08240
    120 Valley Hospital Ridgewood New Jersey United States 07450
    121 Community Medical Center Toms River New Jersey United States 08755
    122 St. Francis Medical Center Trenton New Jersey United States 08629
    123 Associated Radiologists, P.A. Warren New Jersey United States 07059
    124 Radiation Oncology Associates of Albuquerque Albuquerque New Mexico United States 87109
    125 Cancer Center of Albany Medical Center Albany New York United States 12208
    126 State University of New York Health Science Center at Brooklyn Brooklyn New York United States 11203
    127 New York Methodist Hospital Brooklyn New York United States 11215
    128 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    129 Finger Lakes Radiation Oncology Center Clifton Springs New York United States 14432
    130 CCOP - North Shore University Hospital Manhasset New York United States 11030
    131 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    132 Champlain Valley Physicians Hospital Medical Center Plattsburgh New York United States 12901
    133 Vassar Brothers Medical Center Poughkeepsie New York United States 12601
    134 James P. Wilmot Cancer Center Rochester New York United States 14642
    135 CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York United States 13217
    136 Riverhill Radiation Oncology Yonkers New York United States 10701
    137 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    138 Northeast Medical Center Concord North Carolina United States 28025
    139 East Carolina University School of Medicine Greenville North Carolina United States 27858-4354
    140 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    141 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
    142 Trinity Cancer Care Center Minot North Dakota United States 58701
    143 Akron General Medical Center Akron Ohio United States 44302
    144 Akron City Hospital Akron Ohio United States 44304
    145 Christ Hospital Cincinnati Ohio United States 45219
    146 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45267-0502
    147 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    148 University Hospitals of Cleveland Cleveland Ohio United States 44106
    149 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    150 CCOP - Columbus Columbus Ohio United States 43206
    151 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    152 CCOP - Dayton Kettering Ohio United States 45429
    153 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
    154 St. Anthony Hospital Oklahoma City Oklahoma United States 73101
    155 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    156 St. John Health System Tulsa Oklahoma United States 74104
    157 CCOP - Oklahoma Tulsa Oklahoma United States 74136
    158 CCOP - Columbia River Program Portland Oregon United States 97225
    159 Lehigh Valley Hospital Allentown Pennsylvania United States 18105
    160 St. Luke's Hospital Cancer Center Bethlehem Pennsylvania United States 18015
    161 Geisinger Medical Center Danville Pennsylvania United States 17822-2001
    162 Mercy Fitzgerald Hospital Darby Pennsylvania United States 19023
    163 Delaware County Memorial Hospital Drexel Hill Pennsylvania United States 19026
    164 Pocono Cancer Center East Stroudsburg Pennsylvania United States 18301
    165 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    166 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104-4283
    167 Veterans Affairs Medical Center - Philadelphia Philadelphia Pennsylvania United States 19104
    168 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    169 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    170 Albert Einstein Cancer Center Philadelphia Pennsylvania United States 19141-3098
    171 University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15213-3489
    172 Mercy Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15219
    173 Western Pennsylvania Hospital Pittsburgh Pennsylvania United States 15224
    174 Reading Hospital and Medical Center Reading Pennsylvania United States 19612-6052
    175 Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania United States 18501
    176 Wilkes Barre General Hospital Wilkes-Barre Pennsylvania United States 18764
    177 York Hospital York Pennsylvania United States 17315
    178 Roger Williams Medical Center/BUSM Providence Rhode Island United States 02908-4735
    179 CCOP - Greenville Greenville South Carolina United States 29615
    180 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    181 Rapid City Regional Hospital Rapid City South Dakota United States 57709
    182 Jackson-Madison County General Hospital Jackson Tennessee United States 38301-3956
    183 University of Tennessee Cancer Institute Memphis Tennessee United States 38103
    184 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-5671
    185 Harrington Cancer Center Amarillo Texas United States 79106
    186 University of Texas Medical Branch Galveston Texas United States 77555-0209
    187 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    188 Wilford Hall Medical Center Lackland Air Force Base Texas United States 78236-5300
    189 Joe Arrington Cancer Research and Treatment Center Lubbock Texas United States 79410-1894
    190 Bayshore Medical Center Pasadena Texas United States 77504
    191 Dixie Regional Medical Center Saint George Utah United States 84770
    192 University of Utah Health Sciences Center Salt Lake City Utah United States 84132
    193 Latter Day Saints Hospital Salt Lake City Utah United States 84143
    194 Vermont Cancer Center Burlington Vermont United States 05401
    195 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
    196 RMH Regional Cancer Center Harrisonburg Virginia United States 22801
    197 Naval Medical Center, Portsmouth Portsmouth Virginia United States 23708-2197
    198 Bon-Secours - St. Mary's Hospital Richmond Virginia United States 23226
    199 Massey Cancer Center Richmond Virginia United States 23298-0037
    200 Virginia Mason Medical Center Seattle Washington United States 98111
    201 Deaconess Medical Center Spokane Washington United States 99210-0248
    202 Yakima Valley Memorial Hospital Yakima Washington United States 98902
    203 Schiffler Cancer Center Wheeling West Virginia United States 26003
    204 CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin United States 54301
    205 St. Vincent Hospital Green Bay Wisconsin United States 54307-3508
    206 Gundersen Lutheran Medical Foundation La Crosse Wisconsin United States 54601
    207 Southern Wisconsin Radiotherapy Center Madison Wisconsin United States 53713
    208 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792
    209 Marshfield Clinic Marshfield Wisconsin United States 54449
    210 Community Memorial Hospital Menomonee Falls Wisconsin United States 53051
    211 Columbia Hospital Milwaukee Wisconsin United States 53211
    212 St. Luke's Medical Center Milwaukee Wisconsin United States 53215
    213 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    214 Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin United States 53295
    215 All Saints Cancer Center Racine Wisconsin United States 53405
    216 Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    217 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2
    218 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    219 Saint John Regional Hospital Saint John New Brunswick Canada E2L 4L2
    220 Newfoundland Cancer Treatment and Research Foundation St. Johns Newfoundland and Labrador Canada A1B 3V6
    221 Nova Scotia Cancer Centre Halifax Nova Scotia Canada B3H 1V7
    222 Cancer Care Ontario-Hamilton Regional Cancer Centre Hamilton Ontario Canada L8V 5C2
    223 Kingston Regional Cancer Centre Kingston Ontario Canada K7L 5P9
    224 Cancer Care Ontario-London Regional Cancer Centre London Ontario Canada N6A 4L6
    225 Ottawa Regional Cancer Centre Ottawa Ontario Canada K1H 1C4
    226 Northeastern Ontario Regional Cancer Centre, Sudbury Sudbury Ontario Canada P3E 5J1
    227 Northwestern Ontario Regional Cancer Centre, Thunder Bay Thunder Bay Ontario Canada P7A 7T1
    228 Toronto Sunnybrook Regional Cancer Centre Toronto Ontario Canada M4N 3M5
    229 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    230 CHUS-Hopital Fleurimont Fleurimont Quebec Canada J1H 5N4
    231 Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2L 4MI
    232 McGill University Montreal Quebec Canada H2W 1S6
    233 Centre Hospitalier Universitaire de Quebec Quebec City Quebec Canada G1R 2J6
    234 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    235 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4

    Sponsors and Collaborators

    • Radiation Therapy Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Mohammed M. Mohiuddin, MD, Lucille P. Markey Cancer Center at University of Kentucky

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radiation Therapy Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00006366
    Other Study ID Numbers:
    • RTOG-R-0012
    • CDR0000068239
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Dec 1, 2002
    Keywords provided by Radiation Therapy Oncology Group
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 22, 2020