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Ultrafractionated Radiation Therapy for Metastatic Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05021237
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : April 5, 2023
Sponsor:
Collaborator:
Elekta Limited
Information provided by (Responsible Party):
Chika Nwachukwu, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE August 19, 2021
First Posted Date  ICMJE August 25, 2021
Last Update Posted Date April 5, 2023
Actual Study Start Date  ICMJE February 1, 2022
Estimated Primary Completion Date October 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2022)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2021)		 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2022)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2021)
  • 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 CTCAEv5 from the commencement of MRI 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrafractionated Radiation Therapy for Metastatic Cervical Cancer
Official Title  ICMJE A Safety Lead in Single Arm Phase II Study for Image Guided Ultrafractionated Radiation Therapy for Treatment of Metastatic Cervical Cancer
Brief Summary To improve overall survival in patients with metastatic cervical cancer by loco-regional therapy with ultra-fractionated radiation therapy
Detailed 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective Therapeutic Study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage IV Cervical Cancer FIGO 2018
  • Adenosquamous Carcinoma of Cervix
  • Cervical Cancer
  • Metastasis
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Intervention: Radiation: Ultra-fractionated radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2021)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2026
Estimated Primary Completion Date October 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. At least 18 years of age.
  2. Ability to understand and the willingness to sign a written informed consent.
  3. 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
  4. 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.
  5. 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.
  6. Eastern Cooperative Group (ECOG) performance status of 0-3.
  7. 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)

Exclusion Criteria:

  1. Prior radiation treatment to the pelvis.
  2. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
  3. Patients with active Inflammatory Bowel disease or Collagen vascular disease -SLE, scleroderma or on active immunosuppressant (exclusions per PI discretion).
  4. 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.
  5. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  6. Presence of brain metastases that are not amenable to treatment with radiation or surgery, or brain metastasis leading to clinical instability.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female only study
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah Neufeld 214-645-8525 sarah.hardee@UTSouthwestern.edu
Contact: Liliana Robles 214-645-8525 liliana.robles@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05021237
Other Study ID Numbers  ICMJE 2021-0787
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chika Nwachukwu, University of Texas Southwestern Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Elekta Limited
Investigators  ICMJE
Principal Investigator: Chika Nwachukwu, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP