Ultrafractionated Radiation Therapy for Metastatic Cervical Cancer

  • STATUS
    Recruiting
  • End date
    Oct 10, 2026
  • participants needed
    30
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 10 May 2022
cancer
hysterectomy
measurable disease
metastasis
metastatic cervical cancer

Summary

To improve overall survival in patients with metastatic cervical cancer by loco-regional therapy with ultra-fractionated radiation therapy

Description

The standard of care for treatment of locally advanced cervical cancer in the non-metastatic setting is a combination of radiation and chemotherapy. Radiotherapy for non-metastatic cervical cancer currently consists of radiation in the form of external beam delivered over 5-6 weeks of daily therapy followed by or interdigitated with intracavitary brachytherapy. Chemotherapy is used as a sensitizing agent with radiation and this is associated with substantial improvement in local control and overall survival. The treatment of metastatic cervical cancers is challenging, The standard of care for patients with metastatic disease is systemic therapy alone. The treatment of metastatic cervical cancers is challenging, with many patients developing resistance to platinum based chemotherapy and progressing through multiple lines of treatment. Although early stage cervical cancer is highly treatable with an excellent prognosis, recurrent and metastatic disease poses a significant treatment challenge. Several large clinical trials have demonstrated significant improvements in progression free and overall survival rates with the treatment of the local disease in other sites, eg head and neck and prostate cancer . These outcomes have generated optimism for aggressively treating local disease in the metastatic setting. Furthermore retrospective studies have demonstrated improvement in OS with treatment of the primary with radiation in women with metastatic cervical cancer. None of the studies have standardized their methods of treatment. In addition, treating metastatic patients with conventionally fractionated radiation treatment will prolong treatment time and can interrupt with systemic therapy which is critical for distant disease. With imaged-based ultrafractionated radiation, high doses can be delivered without inordinately large expansion margins and shortens treatment time. Moreover, studies have shown that the dose of radiation matters with higher doses associated with improved outcomes. These high doses levels can only be achieved with modern image guidance that limits expansion margins of radiation planning. Further pulsar technique allows for adaptation to the patient's tumor and anatomy and this process reduces the dose to the normal structures, thus minimizing serious toxicity in a metastatic population. There are no prospective trials of radiation in this setting. Currently, the standard of care remains cisplatin-based doublet therapy +/- avastin and this combination with radiation treatment has the potential to change outcomes and the could impact the management for this patient population

Details
Condition Stage IV Cervical Cancer FIGO 2018, Adenosquamous Carcinoma of Cervix, Cervical Cancer, Metastasis
Treatment Ultra-fractionated radiation therapy
Clinical Study IdentifierNCT05021237
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting with the first radiation pulse through 90 days after the last fraction of radiation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Medically acceptable birth control (contraceptives)
includes
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)
A female of child-bearing potential is any woman (regardless of sexual orientation, marital
status, having undergone a tubal ligation, or remaining celibate by choice) who meets the
following criteria
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)

Exclusion Criteria

Prior radiation treatment to the pelvis
Subjects may not be receiving any other investigational agents for the treatment of
the cancer under study
Patients with active Inflammatory Bowel disease or Collagen vascular disease -SLE
scleroderma or on active immunosuppressant (exclusions per PI discretion)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that, in the opinion of the
investigator, would limit compliance with study requirements
Subjects must not be pregnant or nursing due to the potential for congenital
abnormalities and the potential of this regimen to harm nursing infants
Presence of brain metastases that are not amenable to treatment with radiation or
surgery, or brain metastasis leading to clinical instability
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