Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer

NCT ID: NCT05139368

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2027-06-26

Brief Summary

This clinical trial studies the feasibility of using hypo-fractionated radiotherapy for the treatment of cervical or endometrial cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Detailed Description

PRIMARY OBJECTIVE:

I. To establish the trial as feasible and to assess the impact upon acute gastrointestinal toxicity in the third week of pelvic radiotherapy following a hypo-fractionated schedule.

SECODARY OBJECTIVES:

I. To estimate impact upon acute urinary toxicity. II. To estimate impact upon patient reported gastrointestional toxicity. III. To assess acute quality of life following treatment. IV. To quantify acute financial toxicity following treatment. V. To assess satisfaction with decision-making following treatment. VI. To assess the overall survival throughout 3 years of post-treatment follow-up.

OUTLINE:

Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, and 6 months and then at 1, 2, and 3 years.

Conditions

Cervical Carcinoma; Endometrial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (hypo-fractionated radiotherapy)

Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Hypofractionated Radiation Therapy

Intervention Type: RADIATION

Undergo hypofractionated radiation therapy

Interventions

Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Intervention Type: RADIATION

Other Intervention Names

Hypofractionated; Hypofractionated Radiotherapy; hypofractionation; Radiation, Hypofractionated

Eligibility Criteria

Inclusion Criteria

• Subjects aged >= 18 years
• Pathologically confirmed malignancy of the cervix or endometrium. Non-epithelial histologies are permitted. Adenocarcinoma in situ is also permitted
• Patients must be status post hysterectomy for initial management of cervix or endometrial cancer
• Subject must have non-metastatic disease as determined by clinical exam or computed tomography (CT) or positron emission tomography (PET)/CT imaging
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
• Life expectancy of > 2 years
• Chemotherapy can be administered at discretion of the treating radiation, medical, or gynecologic oncologist. Sequential therapy (radiation followed by chemotherapy) is preferred but not required

Exclusion Criteria

• Prior abdominal or pelvic irradiation
• Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks, unless chemotherapy is administered prior to RT. If chemotherapy is administered prior to RT, consult with PI regarding acceptable time frame.
• Prior history of inflammatory bowel disease
• The diagnosis of another malignancy within =< 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, or bladder or of the cervix)
• Medical, psychiatric, cognitive, or other conditions in the opinion of the investigator that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gita Suneja, MD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Locations

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

NCI-2021-12258

Identifier Type: REGISTRY

Identifier Source: secondary_id

HCI144462

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA042014

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HCI144462

Identifier Type: -

Identifier Source: org_study_id