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Radiation Therapy

Shortened Radiotherapy for Post-Mastectomy Breast Cancer

Q: Is this trial presently enrolling new participants?

<p>After reviewing the information on clinicaltrials.gov, it appears that this medical trial is currently enrolling participants. This study was first advertised on November 24th 2020 and has had its details edited most recently in September 8th 2022.</p>

Q: What is the current enrolment rate for this research endeavor?

<p>Affirmative. According to information shared on clinicaltrials.gov, this medical trial commenced on November 24th 2020 and is still live today; it seeks 72 participants from a single location.</p>

Phase < 1

Recruiting

Led By Aftif Khan, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female or male patients with invasive breast cancer who have had mastectomy and have a chest wall reconstruction in progress or completed

Age ≥ 30 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial will test whether giving radiation therapy over five days is safe and effective for people who have had a mastectomy.

Who is the study for?

This trial is for adults over 30 with certain stages of breast cancer (Stage IIa - IIIa) who've had a mastectomy and possibly chest wall reconstruction. They should be in good physical condition, not pregnant or breastfeeding, without distant metastasis or prior radiation to the breast/thorax area. People with uncontrolled conditions like infections or diabetes, connective tissue diseases, or an active second malignancy are excluded.Check my eligibility

What is being tested?

The study is testing if a shortened schedule of radiation therapy—5 consecutive days—is effective and safe for preventing cancer recurrence after mastectomy in breast cancer patients. It's evaluating whether this compressed treatment can match traditional longer schedules.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical side effects from radiation therapy may include skin irritation at the treatment site, fatigue, mild swelling, and changes to the texture and color of the skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a mastectomy and am undergoing or have completed chest wall reconstruction.

Select...

I am 30 years old or older.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Local recurrences

Regional recurrences

Secondary outcome measures

complications

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389

98%

Anemia

93%

Leukocytes decreased

90%

Lymphopenia

84%

Neutrophils decreased

78%

Neuropathy-sensory

75%

Alopecia

74%

Fatigue

67%

Nausea

60%

Hyperglycemia

52%

Constipation

46%

Hypoalbuminemia

40%

Myalgia

34%

Stomatitis

33%

Insomnia

32%

Vomiting

27%

Platelets decreased

26%

Alkaline phosphatase increased

26%

Aspartate aminotransferase increased

23%

Dyspnea

20%

Dyspepsia

19%

Dysphagia

19%

Headache

16%

Anorexia

16%

Arthralgia

15%

Neuropathy-motor

15%

Abdominal pain

14%

Infection w/o neutropenia

14%

Cough

14%

Fever

13%

Rash/desquamation

13%

Diarrhea w/o prior colostomy

12%

Bone pain

11%

Weight gain

11%

Taste disturbance

11%

Anxiety/agitation

10%

Sweating

10%

Radiation dermatitis

Rigors/chills

Dizziness/lightheadedness

Injection site reaction

Hypoglycemia

Dysphagia-esophageal radiation

Blood bilirubin increased

Chest pain

Pain-other

Phlebitis

Creatinine increased

Edema

Pruritus

Hot flashes

Infection w/ grade 3 or 4 neutropenia

Weight loss

Muscle weakness

Depression

Mouth dryness

Transfusion: pRBCs

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism

Febrile neutropenia

Irregular menses

Nail changes

Allergic rhinitis

Allergic reaction

Infection w/ unknown ANC

Syncope

Sinus tachycardia

Dehydration

Neuropathic pain

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Stanford V)

Arm A (ABVD)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Post-Mastectomy RadiotherapyExperimental Treatment1 Intervention

Treatment will consist of PMRT delivered using external beam RT techniques to a dose of 26 Gy in 5 fractions of 5.2 Gy delivered on consecutive weekdays with an optional chest wall boost of 5.2 Gy for 1-2 fractions or an alternate boost schedule of 2.5 Gy for 1-4 fractions at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiotherapy

2017

Completed Phase 3

~2610

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,783 Total Patients Enrolled

203 Trials studying Breast Cancer

81,137 Patients Enrolled for Breast Cancer

Aftif Khan, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04648904 — Phase < 1

Breast Cancer Research Study Groups: Post-Mastectomy Radiotherapy

Breast Cancer Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT04648904 — Phase < 1

Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04648904 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial presently enrolling new participants?

"After reviewing the information on clinicaltrials.gov, it appears that this medical trial is currently enrolling participants. This study was first advertised on November 24th 2020 and has had its details edited most recently in September 8th 2022."

Answered by AI

What is the current enrolment rate for this research endeavor?

"Affirmative. According to information shared on clinicaltrials.gov, this medical trial commenced on November 24th 2020 and is still live today; it seeks 72 participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of a Shortened Radiation Therapy Schedule in People With Breast Cancer

2020. "Study of a Shortened Radiation Therapy Schedule in People With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04648904.