Your session is about to expire
← Back to Search
Radiation Therapy
Hypofractionated Radiation Therapy for Early-Stage Breast Cancer (NOVEMBER Trial)
Phase 2
Waitlist Available
Led By Matthew Poppe
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
NOVEMBER Trial Summary
This trial looks at how well a shorter, high-dose radiation therapy works to treat early-stage breast cancer.
Who is the study for?
This trial is for women with stage 0-IIB breast cancer who can consent to treatment, use birth control or abstain from sex during therapy, and have a good performance status. They must not have had prior chest radiation, other recent cancers (except certain skin cancers or cervical carcinoma in situ), severe medical conditions, or collagen vascular diseases.Check my eligibility
What is being tested?
The study tests hypofractionated radiation therapy on patients with early-stage breast cancer. This method uses higher doses over fewer sessions compared to traditional treatments and aims to be more effective with less side effects.See study design
What are the potential side effects?
While the trial aims for fewer side effects due to its shorter duration of treatment, potential side effects may include skin irritation, fatigue, swelling in the treated area, and changes in breast texture.
NOVEMBER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use birth control or abstain from sex during radiation therapy.
Select...
I am fully active or can carry out light work.
Select...
My breast cancer diagnosis was confirmed through a biopsy.
Select...
My radiation treatment is limited to the breast area, not beyond.
Select...
My cancer is in the early stages and hasn't spread to lymph nodes or other parts of my body.
NOVEMBER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy
Secondary outcome measures
Cost-effectiveness (CE) of Hypofractionated Radiation Versus Standard Fractionation
Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Toxicity
Local and Local Regional Recurrence Rate
+2 moreSide effects data
From 2022 Phase 2 trial • 107 Patients • NCT0332480280%
Dermatitis radiation
54%
Skin hyperpigmentation
48%
Pain
35%
Lymphedema
22%
Superficial soft tissue fibrosis
7%
Skin hypopigmentation
6%
Edema limbs
2%
Device related infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Radiation Therapy, 15 Fractions)
Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)
NOVEMBER Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,620 Total Patients Enrolled
15 Trials studying Breast Cancer
7,124 Patients Enrolled for Breast Cancer
Matthew PoppePrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had breast cancer or DCIS on the same side before, but LCIS or benign conditions are okay.I had complications after a lumpectomy that needed more surgery or IV antibiotics.My other health conditions do not reduce my life expectancy to less than 5 years.I haven't had cancer, except for some skin cancers or cervical pre-cancer, in the last 5 years.I am a woman capable of becoming pregnant.I agree to use birth control or abstain from sex during radiation therapy.I am fully active or can carry out light work.I have an active collagen vascular disease like lupus, scleroderma, or dermatomyositis.I received chemotherapy before radiation treatment.My cancer is either a neuroendocrine carcinoma or sarcoma.I am taking medication to enhance the effects of radiation therapy, as advised by my doctor.My breast cancer diagnosis was confirmed through a biopsy.My radiation treatment is limited to the breast area, not beyond.I had a lumpectomy with no cancer in my lymph nodes, or I am over 70 with a small ER+ tumor, or I only have DCIS.I have or had cancer in my other breast, but benign conditions are okay.I have had radiation therapy to my chest, neck, or armpit area.Women who can have children must have a negative pregnancy test within 7 days before joining the study.My cancer is in the early stages and hasn't spread to lymph nodes or other parts of my body.My lumpectomy showed clear margins, except possibly at the chest muscle layer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Hypofractionated Radiation Therapy been given the stamp of approval by the FDA?
"The safety of Hypofractionated Radiation Therapy, which is currently undergoing a Phase 2 trial, was rated as a 2 due to the limited evidence available for efficacy."
Answered by AI
Is there still capacity for patient enrollment in this experiment?
"Per the information hosted on clinicaltrials.gov, this medical trial is actively enrolling participants. It was first posted in December 12th 2017 and was last updated on October 5th 2022."
Answered by AI
What is the maximum capacity of participants for this research effort?
"Affirmative. Clinicaltrials.gov supports this study's recruitment status, which began on December 12th 2017 and was recently modified October 5th 2022. This trial is looking for 102 patients to join at 1 site."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger