Cervical Carcinoma, Endometrial Carcinoma
Conditions
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.
Interventions
RADIATIONHypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Sponsors
University of Utah
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Toxicity - Bowel Summary Score | from baseline to the week 3 timepoint, up to 6 weeks from the baseline visit | Change in toxicity will be measured by the change in bowel domain score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 14 items in this assessment create the Bowel Summary score. Bowel Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Bowel Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL). This outcome measure will report mean EPIC Bowel Summary scores at the week 3 timepoint. |
| Trial Feasibility - Number of Evaluable Patients | Baseline to week 3 (up to 6 weeks from the baseline visit) | To assess the feasibility of administering a clinical trial to evaluate hypofractionated radiotherapy. This outcome measure will report the number of evaluable patients and the number of patients who started study treatment but were not deemed evaluable. To be considered evaluable, an eligible patient must have completed 3 weeks of treatment and completed EPIC bowel domain questionnaire at baseline and 3 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument | Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) | Change in urinary toxicity will be measured by the change in urinary summary score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 10 items in this assessment create the Urine Summary score. Urine Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Urine Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL). This outcome measure will report mean EPIC Urine Summary scores at the week 3 and 1 year timepoint. |
| Change in Bowel Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument | Baseline to 1 year (up to 14 months from the baseline visit) | Change in toxicity will be measured by the change in bowel domain score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 14 items in this assessment create the Bowel Summary score. Bowel Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Bowel Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL). This outcome measure will report mean EPIC Bowel Summary scores at the week 3 timepoint. |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) | Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) | To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how OFTEN participants experienced Loose or Watery Stools (Diarrhea) in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit). |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen | Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) | To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how OFTEN participants experienced Pain in the Abdomen (Belly Area) in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit). |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen | Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) | To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing the SEVERITY of participants' Pain in the Abdomen (Belly Area) at its WORST in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit). |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen | Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) | To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how much Pain in the Abdomen (Belly Area) INTERFERED with their usual or daily activities in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit). |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement | Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) | To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how OFTEN participants experienced Lose Control of Bowel Movement in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit). |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere | Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) | To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how much Loss of Control of Bowel Movement Interfere INTERFERED with their usual or daily activities in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit). |
| Change in Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) | Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) | To assess acute and 1 year quality of life following treatment as assessed on the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx). FACT-Cx is a 42-item, self-assessed questionnaire rated on a 5-point Likert scale. FACT-Cx total scores range from 0-168, with higher scores indicating better Quality of Life (QOL) and lower scores indicating worse QOL This outcome measure will report the mean change in the FACT-Cx Total Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) timpoints. A positive change indicates the scores increased (improved QOL), and a negative Change indicates the scores decreased (worse QOL). |
| Change in FACIT Measure of Financial Toxicity (FACIT-COST) Score | Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) | To assess acute and 1 year quality of life following treatment as assessed on the FACIT Measure of Financial Toxicity (FACIT-COST). FACT-COST is a 12-item, self-assessed questionnaire rated on a 5-point Likert scale. FACT-COST Score ranges from 0-44, with higher scores indicating better financial well-being and lower scores indicating worse financial well-being. This outcome measure will report the mean change in the FACT-COST Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) time points. A positive change indicates the scores increased (better financial well-being), and a negative Change indicates the scores decreased (worse financial well-being). |
| Decision Regret Scale - Summary Score | Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) | To assess acute and 1 year satisfaction with decision-making following treatment. The Decision Regret Scale is a 5-item, self-assessed questionnaire rated on a 5-point Likert scale. Decision Regret Scale Score ranges from 0-100, with higher scores indicating high regret and lower scores indicating less regret. This outcome measure will report the mean Decision Regret Scale Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) time points. |
| Overall Survival | Time to the earliest of all-cause mortality (event), end of study follow-up (censoring criteria), or loss to follow-up (censoring criteria), assessed up to 3 years | Will use the Kaplan-Meier method to estimate overall survival throughout three years from the time of completing treatment. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGita Suneja, MD
Huntsman Cancer Institute
Participant flow
Recruitment details
Results from this study are preliminary, and meaningful conclusions should not be drawn from the small sample size.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| BMI | 34.01 kg/m^2 STANDARD_DEVIATION 9.86 |
| EPIC Bowel Summary Score | 86.73 score on a scale STANDARD_DEVIATION 12.82 |
| EPIC Urine Summary Score | 92.08 score on a scale STANDARD_DEVIATION 9.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| FACIT Measure of Financial Toxicity (FACIT-COST) Score | 28.33 score on a scale STANDARD_DEVIATION 10.45 |
| FIGO Grade Grade 1 (G1) | 7 Participants |
| FIGO Grade Grade 2 (G2) | 7 Participants |
| FIGO Grade Grade 3 (G3) | 8 Participants |
| FIGO Grade Grade X (GX) | 0 Participants |
| Functional Assessment of Cancer Therapy-Cervix (FACT-Cx). | 132.37 score on a scale STANDARD_DEVIATION 19.68 |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Inte A little bit | 3 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Inte Not at all | 18 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Inte Quite a bit | 0 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Inte Somewhat | 1 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Inte Very much | 0 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen A little bit | 4 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Not at all | 18 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Quite a bit | 0 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Somewhat | 0 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen Very much | 0 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Almost Constantly | 0 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Frequently | 1 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Never | 10 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Occasionally | 5 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea) Rarely | 6 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Almost constantly | 0 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Frequently | 0 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Never | 17 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Occasionally | 1 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement Rarely | 4 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Almost constantly | 0 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Frequently | 0 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Never | 10 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Occasionally | 5 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen Rarely | 7 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Mild | 10 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Moderate | 1 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen None | 11 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Severe | 0 Participants |
| Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen Very severe | 0 Participants |
| Prior Cancer Diagnosis No | 17 Participants |
| Prior Cancer Diagnosis Yes | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 22 |
| other Total, other adverse events | 22 / 22 |
| serious Total, serious adverse events | 4 / 22 |
Outcome results
None listed