NCT00003857 · CITED IN SOURCE DOCUMENTS

Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2022-05-25

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: DISEASE CHARACTERISTICS: * Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis * Unicentric * Lesions ≤ 2.5 cm * Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in \< one third of the involved ducts * Inked margins ≥ 3 mm * Clinically node negative * Non-palpable * No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery * No bloody nipple discharge * No more than 12 weeks since prior final surgery (arm II only) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 26 and over Sex: * Female Menopausal status: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * No active connective tissue disorders (e.g., lupus or scleroderma) * No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills) Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 26 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Observation +/- tamoxifen 20 mg per day for 5 years
intervention Names
Drug: tamoxifen citrate
Procedure: adjuvant therapy
label
Observation +/- tamoxifen for 5 years
type
ACTIVE_COMPARATOR
description
Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
intervention Names
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Radiation: radiation therapy
label
Radiation therapy +/- tamoxifen for 5 years
type
EXPERIMENTAL

interventions

arm Group Labels
Observation +/- tamoxifen for 5 years
Radiation therapy +/- tamoxifen for 5 years
name
tamoxifen citrate
type
DRUG
arm Group Labels
Observation +/- tamoxifen for 5 years
Radiation therapy +/- tamoxifen for 5 years
name
adjuvant therapy
type
PROCEDURE
arm Group Labels
Radiation therapy +/- tamoxifen for 5 years
name
radiation therapy
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 636
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Local recurrence (e.g., invasive or noninvasive recurrence)
time Frame
From randomization to date of local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

secondary Outcomes

measure
Overall survival
time Frame
From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
measure
Time to distant metastasis
time Frame
From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
measure
Invasive local recurrence
time Frame
From randomization to date of invasive local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
measure
Salvage mastectomy rate
time Frame
Analysis occurs after all patients have been potentially followed for 5 years.

Full study description

brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.
detailed Description: OBJECTIVES: * Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast. * Compare distant disease-free survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years. * Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.

Source references

references

citation
McCormick B, Winter K, Hudis C, Kuerer HM, Rakovitch E, Smith BL, Sneige N, Moughan J, Shah A, Germain I, Hartford AC, Rashtian A, Walker EM, Yuen A, Strom EA, Wilcox JL, Vallow LA, Small W Jr, Pu AT, Kerlin K, White J. RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation. J Clin Oncol. 2015 Mar 1;33(7):709-15. doi: 10.1200/JCO.2014.57.9029. Epub 2015 Jan 20.
pmid
25605856
type
RESULT
citation
McCormick B, Winter KA, Woodward W, Kuerer HM, Sneige N, Rakovitch E, Smith BL, Germain I, Hartford AC, O'Rourke MA, Walker EM, Strom EA, Hopkins JO, Pierce LJ, Pu AT, Sumida KNM, Vesprini D, Moughan J, White JR. Randomized Phase III Trial Evaluating Radiation Following Surgical Excision for Good-Risk Ductal Carcinoma In Situ: Long-Term Report From NRG Oncology/RTOG 9804. J Clin Oncol. 2021 Nov 10;39(32):3574-3582. doi: 10.1200/JCO.21.01083. Epub 2021 Aug 18.
pmid
34406870
type
DERIVED