Ultra-fractionated radiation therapy for Uterine Cervical Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UT Southwestern Medical Center, Dallas, TX
Uterine Cervical Neoplasms+5 More
Ultra-fractionated radiation therapy - Radiation
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

Ultrafractionated Radiation Therapy for Metastatic Cervical Cancer

See full description

Eligible Conditions

  • Uterine Cervical Neoplasms
  • Adenosquamous Carcinoma of Cervix
  • Stage IV Cervical Cancer FIGO 2018
  • Cervical Cancers
  • Metastasis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Ultra-fractionated radiation therapy will improve 1 primary outcome and 3 secondary outcomes in patients with Uterine Cervical Neoplasms. Measurement will happen over the course of 90 days.

1 year
QOL (qualify of life)
To evaluate the local-regional progression free survival (LR_PFS)
2 years
To determine if image guided ultrafractionated radiation therapy in metastatic cervical cancer will improve overall survival outcomes
90 days
To assess the acute (< 90 days) grade > 3 toxicity.

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

Safety Lead In
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Ultra-fractionated Radiation Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Safety Lead In
Radiation
Six patients with will be enrolled as first dose of 8.5Gy. If 0 or 1 patient experiences dose-limiting toxicity (DLT) out of six patients, then study will move on to expansion phase. If two or more patients experience DLT out of six patients, 6 additional patients will be recruited to lower dose level of 8Gy

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
C. N.
Prof. Chika Nwachukwu, Assitant Professor
University of Texas Southwestern Medical Center

Closest Location

UT Southwestern Medical Center - Dallas, TX

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received newly diagnosed for Uterine Cervical Neoplasms or one of the other 5 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
1) approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon), or 2) barrier methods (such as a condom or diaphragm) used with a spermicide (a substance that kills sperm).
At least 18 years of age.
Ability to understand and the willingness to sign a written informed consent.
Newly diagnosed FIGO IVB cervical cancer with radiographic evidence of metastatic disease for whom systemic therapy is standard of care, who are within 6 months of systemic therapy treatment, OR Patients with recurrent/metastatic disease with measurable disease in the pelvis for whom systemic therapy is standard of care, who are within 6 months of systemic therapy treatment.
Patients with brain metastasis are allowed as long as they are clinically stable and/or the mets are treated or are amenable to treatment with radiation and/or surgery.
Eastern Cooperative Group (ECOG) performance status of 0-3.
Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Patient Q&A Section

What causes uterine cervical neoplasms?

"Causes include environmental and genetic factors, smoking, and some cancers of the reproductive tract. Data from a recent study suggest that women should be monitored for cancer of the uterine cervix." - Anonymous Online Contributor

Unverified Answer

Can uterine cervical neoplasms be cured?

"The risk of metastatic spread depends on the stage of the uterine cervical lesion at the time of diagnosis and the type of surgical intervention." - Anonymous Online Contributor

Unverified Answer

What are common treatments for uterine cervical neoplasms?

"Most women were offered standard conservative treatments, such as cytotoxic chemotherapy or radiotherapy, which are associated with considerable side effects. This is not well-known to women, and could be a source of distress." - Anonymous Online Contributor

Unverified Answer

What is uterine cervical neoplasms?

"Uterine cervical neoplasms accounted for 15.8% of all cervical malignancies. The histologically detected uterine cervical carcinoma formed the majority of this group (87%). Tumours caused by high-grade squamous intraepithelial neoplasm were the most frequent group (32.3%) followed by high-grade glycogen-rich adenocarcinoma (27.1%). The remainder were differentiated squamous carcinoma with glandular component (11.4%), adenosquamous carcinoma (6.7%) and adenosquamous cell carcinoma (2.8%)." - Anonymous Online Contributor

Unverified Answer

How many people get uterine cervical neoplasms a year in the United States?

"The incidence of cervical cancer incidence of the United States is decreasing for the first time, but the prevalence is increasing to such a high rate as to become an important public health concern, a change that has the potential to have a major impact on the survival of many women in the near future." - Anonymous Online Contributor

Unverified Answer

What are the signs of uterine cervical neoplasms?

"Signs of uterine disease can be detected by using a simple clinical evaluation. Urine analysis is an easy and useful technique for assessing for dysphemics, such as urgency or residual blood in the urine. The most helpful method in diagnosing a uterine neoplasm is the biopsy combined with a pelvic examination of the patient." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for uterine cervical neoplasms?

"The benefit of adjuvant chemotherapy in patients with cervical cancer justifies its use not only in those who receive radiation but also in those receiving primary radiotherapy. Because radiotherapy is the sole modality commonly used in treatment of uterine cervical neoplasms, patients who are treated by primary radiotherapy can be considered as optimal candidates for clinical trials." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving ultra-fractionated radiation therapy?

"There are more than 100 reports about IF-RT in the scientific literature, but there are only a few (10 to 11) reviews in which a meta-analysis is included. Given the many reported IF-RT trials (about 1/3 have no randomization), the reviews provided a clear message that IF-RT should not be used as frontline therapy for the aforementioned indications. However, a few studies are reporting positive results for IF-RT in the management of cervical cancer in patients with recurrent disease." - Anonymous Online Contributor

Unverified Answer

Does ultra-fractionated radiation therapy improve quality of life for those with uterine cervical neoplasms?

"For patients with uterine cervical carcinoma treated with radical radiation therapy, improvement in general and specific functional health-related quality of life after treatment was not evident. The treatment-related distress did not translate into impaired quality of life after adjusting for other explanatory factors." - Anonymous Online Contributor

Unverified Answer

Has ultra-fractionated radiation therapy proven to be more effective than a placebo?

"A phase III clinical trial is evaluating UFRT compared with a non-placebo therapy for patients with uterine cervical [non-small cell] cancer. The study was initiated following a phase I clinical trial with comparable results." - Anonymous Online Contributor

Unverified Answer

What does ultra-fractionated radiation therapy usually treat?

"The treatments mentioned in a number of recent reviews may be useful, but there are no definitive treatments that have been approved for patients with low grade dysplasia." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of ultra-fractionated radiation therapy?

"UFT RT-related AEs are common with incidences similar to conventional RT. AEs are rarely severe for all dosages. Severe AEs can be minimized by reducing RT doses and/or expanding eligibility for lower doses of RT." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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