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Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy for Metastatic Cervical Cancer

StatusCompleted
PhasePhase 2
Started2022-02-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-18
Trial completed
Primary completion confirmed: June 2026 (last estimated August 2028)
2025-08-21
Recruiting→Active, Not Recruiting Study Status, Oversight, Study Design, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 30→confirmed 12
Study sitesdetails revised at 1 of 1 site
2024-09-25
Study Status v9
Primary completion date2026-10→2028-08
Completion date2026-10→2028-08
2024-09-10
Study Status, Oversight, Eligibility, Contacts/Locations v8
Eligibility criteria+133 characters
Inclusion Criteria: At least 18 years of age. Ability to understand and the wil [...] in the pelvis for whom systemic therapy is standard of care, and who are within 6 months of initiation of systemic thera [...] d menses at any time in the preceding 12 consecutive months). 8. Biopsy of primary tumor or recurrent site within 6 months prior to registration Exclusion Criteria: Prior radiation treatment to the pelvis, unless it was for palliation with a total of <=9GY. Subjects may not be receiving any other investigational ag [...]
Study sitescontacts updated at 1 of 1 site
2024-02-27
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v7
Eligibility criteria+8 characters
[...] n the pelvis for whom systemic therapy is standard of care, and who are within 6 months of initiation of systemic therapy treatment. Patients with brain metastasis are allowed as long as they [...]
Secondary endpoints3 to 2 entries
To assessdetermine the acute and late genitourinary (< 90 daysGU) and lategastrointestinal (>90daysGI) grade > 3 toxicity.toxicities To evaluate the local-regional progression freeafter survival (LR_PFS) QOL (qualify of life)treatment
Primary endpoints1 entry, revised
To determine if image guided ultrafractionatedultra-fractionated radiationstereotactic therapyadaptive radiotherapy in metastatic/locally recurrent cervical cancer will improve overall survival outcomes
Study description-1,239 characters
The standardpoor of care for treatment of locally advanced cervical cancer in the non-metastatic setting is a combination of radiationoutcomes and chemotherapy. Radiotherapylocal for non-metastatic cervical cancer currently consistsmorbidity 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 [...] disease in other sites, eg head and neck and prostate c [...] [...]
Study title+31 characters
UltrafractionatedPersonalized RadiationUltra-fractionated TherapyStereotactic Adaptive Radiotherapy for Metastatic Cervical Cancer
Show 6 earlier versions
2023-09-07
Study Status, Sponsor/Collaborators, Outcome Measures, Contacts/Locations v6
Secondary endpoints3 entries, revised
To assess the acute (< 90 days) and late (>90days) grade > 3 toxicity.
Primary endpoints1 entry, revised
To determine if image guided ultrafractionated radiation therapy in metastatic/locally recurrent cervical cancer will improve overall survival outcomes
Study sitescontacts updated at 1 of 1 site
2023-04-03
Study Status, Contacts/Locations v5
Study sitescontacts updated at 1 of 1 site
2022-04-29
Study Status, Outcome Measures, Contacts/Locations v4
Secondary endpoints2 to 3 entries
QOL (qualify of life)
2022-02-07
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-10→2026-10
Completion date2025-10→2026-10
Start dateestimated 2022-01→confirmed 2022-02-01
Study sites0→1
Eligibility criteria+203 characters
[...] and and the willingness to sign a written informed consent. PathologicNewly diagnosis ofdiagnosed 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 [...] d or are amenable to treatment with radiation and/or surgery. Eastern Cooperative [...] [...]
2021-11-30
Study Status, Conditions v2
Start date2021-10→2022-01
2021-09-29
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
Eligibility criteria-237 characters
[...] cancer with radiographic evidence of metastatic disease, OR Patients local or regionalwith recurrent (pelvic)/metastatic disease postwith radicalmeasurable hysterectomydisease in pelvis Patients with brain metastasis are allowed as long as they [...] Eastern Cooperative Group (ECOG) performance status of 0-3. Laboratory values supporting acceptable organ and marrow function within 30 days of eligibility confirmation. Defined as follows: WBC ≥ 3,000/mL; ANC WBC ≥ 1,500/mL; PLT ≥ 75,000/mL; T Bili ≤ 1.5 x upper limit of normal (ULN); AST/ALT ≤ 2.5 x ULN; Women of child-bearing potential must agree to [...] [...]
Secondary endpointsdetails revised at 1 of 2 entries
Study description+685 characters
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 [...] The treatment of metastatic cervical cancers is challenging, [...] emonstrated improvement in OS with treatment of the primary with radiation in women with metastatic cervical cancer. None of the studie [...] reating metastatic patients with conventionally fractionated radiation treatment will prolong treatment t [...]
Collaborators+14 characters
Elekta Limited
Study title-64 characters
Phase II Study for Image Guided Ultrafractionated Radiation Therapy for Treatment of Metastatic/ Locally Recurrent Cervical Cancer
2021-08-19
Original filing
To improve overall survival in patients with metastatic cervical cancer by loco-regional therapy with personalized ultra-fractionated radiation
Trial Details
NCT Number NCT05021237
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: Elekta Limited
Conditions Stage IV Cervical Cancer FIGO 2018, Adenosquamous Carcinoma of Cervix, Cervical Cancer, Metastasis
Enrollment 12 participants
Start Date 2022-02-01
Primary Completion 2026-06-02 (estimated)
Study Completion 2026-06-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-17