Ultrafractionated Radiation Therapy for Metastatic Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT05021237|
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : April 5, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Stage IV Cervical Cancer FIGO 2018 Adenosquamous Carcinoma of Cervix Cervical Cancer Metastasis||Radiation: Ultra-fractionated radiation therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective Therapeutic Study|
|Masking:||None (Open Label)|
|Official Title:||A Safety Lead in Single Arm Phase II Study for Image Guided Ultrafractionated Radiation Therapy for Treatment of Metastatic Cervical Cancer|
|Actual Study Start Date :||February 1, 2022|
|Estimated Primary Completion Date :||October 2026|
|Estimated Study Completion Date :||October 2026|
Experimental: Safety Lead In
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
Radiation: Ultra-fractionated radiation therapy
Patients enrolled in this study are planned to receive systemic therapy. Imaging based Ultra-fractionated radiation therapy using a PULSAR technique, which is 5 pulses to gross tumor in pelvis.
- To determine if image guided ultrafractionated radiation therapy in metastatic cervical cancer will improve overall survival outcomes [ Time Frame: 2 years ]Overall Survival will be assessed as the percent of patients surviving at each time point. Overall survival is defined as time from diagnosis till death.
- To assess the acute (< 90 days) grade > 3 toxicity. [ Time Frame: 90 days ]Toxicities will be defined as acute (< 90 days) grade > 3 GI and GU toxicity as assessed by CTCAE Version 5.0 (common terminology criteria for adverse events) from the commencement of image Guided Hypofractionated Radiation Treatment boost.
- To evaluate the local-regional progression free survival (LR_PFS) [ Time Frame: 1 year ]The rate of local regional recurrence will be defined as disease recurrence in the pelvis and will be recorded on a time interval from start of radiation treatment to local progression or death. This will be evaluated as a median and rate up to 1 year post treatment.
- QOL (qualify of life) [ Time Frame: 1 year ]To determine quality of life (QOL) in patients treated with radiation. Quality of life will be measured using the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) and EORTC QLQ-CX24 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-cervical cancer specific) questionnaires. The surveys will include the EORTC QLQ-C30 which assesses global health-related quality of life, the EORTC QLQ-CX24 which is targeted to patients with cervix cancer. Questionnaires will be scored according to published scoring guidelines. All patients on study will be asked to participate in this correlative quality of life component and will complete 2 surveys at 3 time points: baseline, 3 months post-treatment and 1-year post-treatment.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Female only study|
|Accepts Healthy Volunteers:||No|
- 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:
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).
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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05021237
|Contact: Sarah Neufeld||214-645-8525||sarah.hardee@UTSouthwestern.edu|
|Contact: Liliana Roblesfirstname.lastname@example.org|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Chika. Nwachukwu, MD 214-645-8525 email@example.com|
|Contact: Sarah Neufeld, MS 2146458525 firstname.lastname@example.org|
|Principal Investigator:||Chika Nwachukwu, MD||UT Southwestern Medical Center|
|Responsible Party:||Chika Nwachukwu, Assitant Professor, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
|First Posted:||August 25, 2021 Key Record Dates|
|Last Update Posted:||April 5, 2023|
|Last Verified:||April 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Uterine Cervical Neoplasms
Genital Neoplasms, Female
Neoplasms by Site
Uterine Cervical Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial