Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | February 1, 2018 |
End Date: | August 2035 |
Contact: | Matthew Poppe, MD |
Email: | Matthew.Poppe@hci.utah.edu |
Phone: | 801-581-8793 |
RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction
This randomized phase III trial studies how well hypofractionated radiation therapy works in
preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy.
Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter
period of time and may kill more tumor cells that remain after surgery and have fewer side
effects.
preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy.
Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter
period of time and may kill more tumor cells that remain after surgery and have fewer side
effects.
PRIMARY OBJECTIVES:
I. To evaluate whether the reconstruction complication rate at 24 months post radiation is
non-inferior with hypofractionation.
SECONDARY OBJECTIVES:
I. To evaluate the incidence of acute and late radiation complications, based on Common
Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity.
II. To evaluate the local and local regional recurrence rate. III. To compare reconstruction
complication rates based on reconstruction method (autologous +/- implant versus [vs] implant
only) and timing of reconstruction received (immediate vs. intent for delayed).
TERTIARY OBJECTIVES:
I. To evaluate reconstructed breast photographic cosmetic scores with hypofractionated
radiation compared to standard fractionation 24 months after radiation.
II. To evaluate reconstructed breast photographic cosmetic scores 24 months after radiation
based on the method and timing of reconstruction received.
III. To estimate the incidence of arm lymphedema by treatment arm. IV. To compare physical
well-being, psychosocial well-being, sexual well-being, satisfaction with
breast/nipples/abdomen, and satisfaction with overall outcome between the treatment arms at
24 months after radiation.
V. To estimate patient satisfaction with trial participation by treatment arm as measured by
the Was It Worth It Questionnaire at 24 months after radiation.
VI. To compare the direct and indirect patient costs for radiation therapy by treatment arm.
VII. To compare patient reported total health care service utilization 12 months after the
completion of radiation.
VIII. To compare the economic impact of treatment. IX. To analyze polymorphisms in MDM2 and
in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 and determine correlations with a
higher likelihood of adverse radiation reactions (radiation sensitivity) and with toxicities.
X. To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and
IL10 to determine correlations with secondary endpoints such as local-regional control.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.
GROUP II: Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4
weeks.
After completion of study, patients are followed up for 5 years.
I. To evaluate whether the reconstruction complication rate at 24 months post radiation is
non-inferior with hypofractionation.
SECONDARY OBJECTIVES:
I. To evaluate the incidence of acute and late radiation complications, based on Common
Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity.
II. To evaluate the local and local regional recurrence rate. III. To compare reconstruction
complication rates based on reconstruction method (autologous +/- implant versus [vs] implant
only) and timing of reconstruction received (immediate vs. intent for delayed).
TERTIARY OBJECTIVES:
I. To evaluate reconstructed breast photographic cosmetic scores with hypofractionated
radiation compared to standard fractionation 24 months after radiation.
II. To evaluate reconstructed breast photographic cosmetic scores 24 months after radiation
based on the method and timing of reconstruction received.
III. To estimate the incidence of arm lymphedema by treatment arm. IV. To compare physical
well-being, psychosocial well-being, sexual well-being, satisfaction with
breast/nipples/abdomen, and satisfaction with overall outcome between the treatment arms at
24 months after radiation.
V. To estimate patient satisfaction with trial participation by treatment arm as measured by
the Was It Worth It Questionnaire at 24 months after radiation.
VI. To compare the direct and indirect patient costs for radiation therapy by treatment arm.
VII. To compare patient reported total health care service utilization 12 months after the
completion of radiation.
VIII. To compare the economic impact of treatment. IX. To analyze polymorphisms in MDM2 and
in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 and determine correlations with a
higher likelihood of adverse radiation reactions (radiation sensitivity) and with toxicities.
X. To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and
IL10 to determine correlations with secondary endpoints such as local-regional control.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.
GROUP II: Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4
weeks.
After completion of study, patients are followed up for 5 years.
Inclusion Criteria:
- Histologically confirmed invasive carcinoma of the breast of any of the following
histologies (ductal, lobular, mammary, medullary, or tubular); in-situ disease alone
is not allowed
- Patients will be staged according to the TNM staging system; pathologic stage T0N1-2a,
T1N1a-2a, T2N1-2a, T3N0-2a, all M0 status; pathological stage for all patients not
receiving neoadjuvant chemotherapy; higher of the clinical or pathological T and N
stage, if receiving neoadjuvant chemotherapy; patients with pathological N0 at the
time of mastectomy are only eligible if biopsy-proven clinically N1 or N2 disease is
documented prior to induction chemotherapy
* Note: All patients with clinical, radiographic or pathological T4, N3 or involved
internal mammary disease (N1b, N1c, and N2b) will not be eligible to enroll
- No prior radiation therapy to the chest, neck or axilla
- No prior history of ipsilateral breast cancer (invasive disease or ductal breast
carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease
is allowed
- No history of prior or concurrent contralateral invasive breast cancer; benign breast
disease, LCIS or DCIS of contralateral breast is allowed
- No active collagen vascular diseases, such as: systemic lupus erythematous,
scleroderma, or dermatomyositis
- Negative inked histologic margins from mastectomy pathology (no invasive cells at
margin)
- No significant post mastectomy complications in the ipsilateral breast requiring an
unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for
margins evaluation, nodal completion and routine reconstruction is acceptable
- Radiation oncologist intends to treat all target volumes and respect all normal
tissues in accordance with the dosimetric constraints described (simulation before
registration recommended)
- Radiation oncologist is planning to treat regional lymph nodes including internal
mammary nodes and meet acceptable protocol dosimetric requirements
- Radiation oncologist is NOT planning to utilize a chest wall/scar boost
- Patient must have undergone immediate reconstruction at the time of mastectomy or be
planning to undergo reconstruction within 18 months after radiation
- If a tissue expander is utilized it needs to be a fluid filled expander, NO air
expander (unless completely deflated) during radiation therapy
- For patients with diabetes, hemoglobin A1C test must have been performed =< 90 days
prior to registration
- No co-existing medical conditions with life expectancy < 5 years
- No other malignancy within 5 years of registration with the exception of basal cell or
squamous cell carcinoma of the skin treated with local resection only or carcinoma in
situ of the cervix
- Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of
child-bearing potential =< 7 days prior to registration; a female of childbearing
potential is a sexually mature female who has not undergone a hysterectomy or
bilateral oophorectomy and has not been naturally postmenopausal for at least 12
consecutive months
- Women of child-bearing potential must agree to utilize a form of birth control or
agree to undergo sexual abstinence during radiation therapy
- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
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Belpre, Ohio 45714
Belpre, Ohio 45714
(740) 401-0417
![Strecker Cancer Center-Belpre](/wp-content/uploads/logos/strecker-cancer-center-belpre.jpg)
Principal Investigator: Timothy D. Moore
Phone: 800-523-3977
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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Bemidji, Minnesota 56601
Principal Investigator: Preston D. Steen
Phone: 218-333-5000
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Bend, Oregon 97701
Principal Investigator: Alison K. Conlin
Phone: 541-706-2909
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Berlin, Vermont 05602
Principal Investigator: Carl J. Nelson
Phone: 802-225-5400
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
![Walter Reed National Military Medical Center](/wp-content/uploads/logos/walter-reed-national-military-medical-center.jpg)
Principal Investigator: Aaron D. Reed
Phone: 301-319-2100
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Bethlehem, Pennsylvania 18015
Principal Investigator: Nimisha Deb
Phone: 888-823-5923
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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1233 North 30th Street
Billings, Montana 59101
Billings, Montana 59101
406-237-7000
![Saint Vincent Healthcare](/wp-content/uploads/logos/saint-vincent-healthcare.png)
Principal Investigator: Keren Sturtz
Phone: 406-969-6060
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Billings, Montana 59102
Principal Investigator: Keren Sturtz
Phone: 800-648-6274
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300 N. Seventh St.
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6000
![Sanford Bismarck Medical Center](/wp-content/uploads/logos/sanford-bismarck-medical-center.jpg)
Principal Investigator: Preston D. Steen
Phone: 701-323-5760
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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1505 Eastland Drive
Bloomington, Illinois 61701
Bloomington, Illinois 61701
309-662-2102
![Illinois CancerCare-Bloomington](/wp-content/uploads/logos/illinois-cancercare-bloomington.gif)
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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100 E Idaho St
Boise, Idaho 83712
Boise, Idaho 83712
(208) 381-2711
![Saint Luke's Mountain States Tumor Institute](/wp-content/uploads/logos/saint-luke-s-mountain-states-tumor-institute.gif)
Principal Investigator: Alison K. Conlin
Phone: 773-702-9171
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, Idaho 83706
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Bonne Terre, Missouri 63628
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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Boone, Iowa 50036
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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1100 Balsam Ave
Boulder, Colorado 80304
Boulder, Colorado 80304
(303) 440-2273
![Boulder Community Hospital](/wp-content/uploads/logos/boulder-community-hospital.jpg)
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Boulder, Colorado 80303
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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915 Highland Blvd
Bozeman, Montana 59715
Bozeman, Montana 59715
(406) 414-5000
![Bozeman Deaconess Hospital](/wp-content/uploads/logos/bozeman-deaconess-hospital.jpg)
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Brainerd, Minnesota 56401
Principal Investigator: Bret E. Friday
Phone: 773-702-9171
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Bremerton, Washington 98310
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Bristol, Tennessee 37620
Principal Investigator: Asheesh Shipstone
Phone: 423-578-8538
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Bristol, Virginia 24201
Principal Investigator: Asheesh Shipstone
Phone: 423-578-8538
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Bronx, New York 10467
Principal Investigator: Jana L. Fox
Phone: 718-379-6866
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Bronx, New York 10461
Principal Investigator: Jana L. Fox
Phone: 718-379-6866
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Bronx, New York 10461
Principal Investigator: Jana L. Fox
Phone: 718-379-6866
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263 7th Avenue
Brooklyn, New York 11215
Brooklyn, New York 11215
Principal Investigator: Hani L. Ashamalla
Phone: 718-780-3677
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Brownstown, Michigan 48183
Principal Investigator: Jessica M. Bensenhaver
Phone: 313-916-3721
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Bryan, Texas 77802
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Burbank, California
Principal Investigator: Alison K. Conlin
Phone: 818-847-4793
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Burien, Washington 98166
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Burlington, Vermont 05405
Principal Investigator: Carl J. Nelson
Phone: 802-656-4101
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Burlington, Wisconsin 53105
Principal Investigator: Ellen L. Ziaja
Phone: 414-302-2304
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
(952) 892-2000
![Fairview Ridges Hospital](/wp-content/uploads/logos/fairview-ridges-hospital.png)
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Burr Ridge, Illinois 60527
Principal Investigator: Tarita O. Thomas
Phone: 708-216-9000
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3123 Medical Dr
Caldwell, Idaho 83605
Caldwell, Idaho 83605
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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210 W Walnut St
Canton, Illinois 61520
Canton, Illinois 61520
309-647-5240
![Illinois CancerCare - Canton](/wp-content/uploads/logos/illinois-cancercare---canton.jpg)
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
573-331-3000
![Saint Francis Medical Center](/wp-content/uploads/logos/saint-francis-medical-center.png)
Principal Investigator: Bryan A. Faller
Phone: 573-334-2230
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
(573) 519-4725
![Southeast Cancer Center](/wp-content/uploads/logos/southeast-cancer-center.png)
Principal Investigator: Bryan A. Faller
Phone: 573-651-5550
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Carbondale, Illinois 62902
Principal Investigator: Bryan A. Faller
Phone: 618-457-5200
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Carterville, Illinois 62918
Principal Investigator: Bryan A. Faller
Phone: 618-985-3333
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160 S Adams St
Carthage, Illinois 62321
Carthage, Illinois 62321
(217) 357-6877
![Illinois CancerCare - Carthage](/wp-content/uploads/logos/illinois-cancercare---carthage.jpg)
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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