Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

  • STATUS
    Recruiting
  • End date
    Aug 23, 2035
  • participants needed
    880
  • sponsor
    Alliance for Clinical Trials in Oncology
Updated on 23 November 2020
Investigator
Matthew Poppe, MD
Primary Contact
Epic Care Cyberknife Center (0.7 mi away) Contact
+863 other location
diabetes
cancer
hysterectomy
beta-human chorionic gonadotropin
carcinoma
non-melanoma skin cancer
oophorectomy
human chorionic gonadotropin
tumor cells
carcinoma in situ
lobular carcinoma
hemoglobin a1c
beta human chorionic gonadotropin
skin carcinoma
invasive breast cancer
mastectomy
ductal carcinoma in situ
lobular carcinoma in situ
invasive carcinoma

Summary

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.

Description

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.

Details
Treatment radiation therapy, laboratory biomarker analysis, questionnaire administration, quality-of-life assessment, hypofractionated radiation therapy
Clinical Study IdentifierNCT03414970
SponsorAlliance for Clinical Trials in Oncology
Last Modified on23 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Invasive Breast Carcinoma or Tubular Breast Carcinoma or Lobular carcinoma or Stage II Breast Cancer or Stage IIIA Breast Cancer or Invasive Ductal Br...?
Do you have any of these conditions: Invasive Breast Carcinoma or Stage IIIA Breast Cancer or Lobular carcinoma or ductal adenocarcinoma or Invasive Ductal Breast Carcinoma or breast duct...?
Do you have any of these conditions: Medullary Breast Carcinoma or Stage II Breast Cancer or Stage IIB Breast Cancer or Invasive Breast Cancer or Tubular Breast Carcinoma or Lobular carci...?
Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular); patients with metaplastic breast cancer are not eligible
Patients will be staged according to the TNM staging system
For patients not receiving neoadjuvant chemotherapy, pathologic staging must be T0N1-2a, T1N1-2a, T2N1-2a, T3N0-2a, and all M0 status
For patients receiving neoadjuvant chemotherapy, clinical pre-chemo staging and post mastectomy pathological staging is required for all patients; patients who have received neoadjuvant chemotherapy and are pathologically cT0-2 and N0 are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to the start of neoadjuvant chemotherapy; cT3N0 patients or ypT3N0 patients who receive neoadjuvant chemotherapy may be eligible based on clinical or pathological T stage, and do not require pathologically positive lymph nodes
Note: Higher of the clinical or pathological T and N stage are used for final staging, if receiving neoadjuvant chemotherapy; all patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) are not eligible
No prior therapeutic radiation therapy to the chest, neck or axilla; prior radioactive oral iodine is permitted
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
Patients must be able to read and comprehend English, in order to be able to complete study questionnaires; however, patients participating through Canadian Cancer Trials Group (CCTG) institutions who can read and comprehend French are eligible
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