Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Endometrial Neoplasms

Uterine Cervical Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Cervical Diseases

Radiation therapy

Akila Viswanathan, MD, MPH

The purpose of this study is to investigate the effect of certain variables such as the fullness of the patients bladder and the position of the treatment applicator on the dose of radiation that other organs such as the bladder and the rectum receive during radiation treatment for endometrial carcinoma.

* This study is separated into 2 phases. In phase 1, patients will be asked to have their bladder full for the second planned insertion of the brachytherapy applicator and empty for the third insertion. For phase 2, the effect of cylinder angle on normal tissue dosimetry will be investigated. Of the two bladder states assessed in phase 1 (empty or full), the one deemed to give the lower dose to the total amount of bladder tissue will be considered the standard and applied to all patients in phase 2.
* In phase 1, to standardize bladder filling, patients will be asked to empty their bladder, then to drink 32 oz of water one and a half hours before the CT scan. The patient will undergo a treatment-planning scan after the brachytherapy cylinder is inserted and before brachytherapy treatment.
* In phase 2, patients will be asked to fill or empty their bladder according to the results of phase 1. The vaginal cylinder will be placed horizontally for the second treatment. The cylinder will then be angled at a specific angle for the subsequent treatment.
* A history and physical exam will be performed within 2 weeks of study entry, then at 14 days, 90 days, and 180 days following the completion of therapy.

Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma

Brigham and Women's Hospital

Dana-Farber Cancer Institute

Akila Viswanathan, MD

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Sarcoma

Cystadenocarcinoma, Serous

Carcinosarcoma

Mixed Tumor, Mullerian

Adenocarcinoma, Clear Cell

Cystadenocarcinoma

Carcinoma, Endometrioid

Neoplasms, Connective and Soft Tissue

Neoplasms, Cystic, Mucinous, and Serous

Ovarian Neoplasms

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Soft Tissue Sarcoma

Malignant Mixed Mullerian Tumor

Uterine Sarcoma

Uterine Carcinosarcoma

Adenocarcinoma of the Appendix

Ovarian Cancer

Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.

Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.

Undergo standard of care vaginal cuff brachytherapy

Vaginal Cuff Brachytherapy

Undergo short course vaginal cuff brachytherapy

Short course vaginal cuff brachytherapy

Cristina DeCesaris, MD

Mathew G Geena

Anuja Jhingran, MD

Rachel Kingsford

This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells.

After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.

PRIMARY OBJECTIVES:

I. Evaluate the non-inferiority of participant health related quality of life (HRQOL) using the Global Health Score from the Quality of Life Questionnaire Core 30 (QLQ-C30) in the 2 arms one month after treatment.

SECONDARY OBJECTIVES:

I. Compare treatment-related symptoms on HRQOL using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), question 48 between the two treatment arms.

II. Compare cost effectiveness between the two treatment arms.

TERTIARY OBJECTIVES:

I. Report vaginal, bowel, and bladder symptoms on HRQOL using the EORTC EN24 the two treatment arms.

II. Evaluate toxicities between the two treatment arms. III. Compare local recurrence and document patterns of recurrence between the two treatment arms. There will be two analyses: A single interim evaluation of patterns of recurrence will be performed after a minimum of 75 participants have been accrued, and the second evaluation will be performed at the end of the study.

IV. Evaluate and compare doses to organs at risk (bladder, rectum, sigmoid colon, and urethra) and the prescribed target in the two arms.

V. Compare total distance traveled to the cancer center for study related visits.

OUTLINE: Participants are randomized to 1 of 2 arms.

Arm I: Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.

Arm II: Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.

After completion of study treatment, participants are followed up at 1, 6, and 12 months.

COHORT 2 (PILOT EXPANSION)

PRIMARY OBJECTIVES:

I. The primary objective is to evaluate the frequency and severity of participant-reported financial toxicity in participants with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one-month post-VCB.

SECONDARY OBJECTIVES:

I. Secondary objectives include evaluation of participant-reported diet and physical activity levels and quality of life in participants with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one-month post-VCB.

EXPLORATORY OBJECTIVES:

I. Exploratory objectives will include evaluation of differences in participant-reported financial toxicity, dietary and physical activity habits between cohorts, to assess any impact of treatment duration on outcomes.

Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer

Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)

The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) is used to evaluate quality of life in cancer patients. The questionnaire was given before and one month following treatment. The quality of life score ranges from 0-100, with higher scores indicating better quality of life. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.

One month post-brachytherapy, participants will be given the Functional Assessment of Chronic Illness Therapy (FACIT) - COmprehensive Score for financial Toxicity (COST) (FACIT-COST) questionnaire. The score range is 0-44, with higher scores indicating better financial well-being. Mean scores will be reported.

The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial-24 (QLQ-EN24) was used to evaluate quality of life in cancer patients with endometrial cancers. The questionnaire was given before and one month following treatment. From this assessment, one question was selected as an indicator for this outcome, which measured whether participants felt less feminine as a result of their disease or treatment. The score ranges from 0-100, with higher scores indicating feeling less feminine. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.

The amount charged to participants or their insurance in US Dollars (USD) was collected to evaluate cost of experimental versus standard of care courses of treatment. Data was collected at approximately six months after treatment.

Participants will be asked to complete the National Cancer Institute (NCI) Diet History Questionnaire 3 (DHQIII) through the NCI website. Additional information about the questionnaire, methods, and measurements will be updated when results are reported for this outcome.

Participants will be asked to complete the NCI Activities Completed over Time in 24-hours (ACT24) questionnaire through the NCI website. Additional information about the questionnaire, methods, and measurements will be updated when results are reported for this outcome.

Mean scores from the FACIT-COST (from Outcome Measure 2: Participant-Reported Financial Toxicity) will be correlated with mean QoL scores (from Outcome Measure 1). Additional information about the methods and measurements will be updated when results are reported for this outcome.

University of Utah

Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.

Experimental: Short Course Vaginal Cuff Brachytherapy

Control: Standard of Care Vaginal Cuff Brachytherapy

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) is used to evaluate quality of life in cancer patients. The quality of life score ranges from 0-100, with higher scores indicating better quality of life.

The primary outcome related to this baseline measure requires participants to have completed both the baseline and Month 1 assessments to be included. Participants without both were excluded in this baseline measure. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Two experimental arm participants did not complete the Month 1 questionnaire.

Baseline EORTC Quality of Life Score

The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial-24 (QLQ-EN24) was used to evaluate quality of life in cancer patients with endometrial cancers. From this assessment, one question was selected as an indicator for this outcome, which measured whether participants felt less feminine as a result of their disease or treatment. The score ranges from 0-100, with higher scores indicating feeling less feminine.

The secondary outcome related to this baseline measure requires participants to have completed both baseline and Month 1 questionnaires to be included. Participants who did not complete both were excluded. Five control arm participants did not complete the Month 1 questionnaire. One control arm participant did not complete the baseline questionnaire. Three experimental arm participants did not complete the Month 1 questionnaire.

Baseline EORTC Symptom Score

IIT Data Management Team

Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participant was excluded because they did not complete the baseline questionnaire. Two experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.

Change in Quality of Life From Baseline to 1 Month

Cohort 2: Participant-Reported Financial Toxicity

Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participants was excluded because they did not complete the baseline questionnaire. Three experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.

Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48

Amount charged for procedures could not be obtained for six participants on the experimental arm.

USD Amount Charged for Procedures

Cohort 2: Participant-Reported Diet

Cohort 2: Participant-Reported Activity Levels

Cohort 2: Financial Toxicity Correlated With Quality of Life

Overall Study

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles

Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted

Carboplatin IV on day 1 of a 21 day cycle for 3 cycles

Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles

Kathleen Moore, MD

The purpose of this study is to determine the feasibility of treatment in patients with high risk endometrial cancer treated by vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy.

Before the patient begins the study:

Endometrial cancer is commonly treated with surgery. The patient must have already had surgery including hysterectomy (removal of the uterus) prior to being considered eligible for this study. The surgery may also include removal of pelvic and para-aortic lymph nodes. Following the surgery, the doctor will identify if the patient has factors related to the cancer which places the patient at a greater risk for the cancer returning.

Prior to participating in this study there are exams, tests or procedures to find out if the patient can be treated in the study. Most are part of regular cancer care.

Treatment:

All patients will receive radiation therapy followed by three cycles of dose dense paclitaxel and carboplatin chemotherapy. Radiation therapy will be delivered either by LDR or HDR brachytherapy and must be specified at the time of enrollment. The vaginal brachytherapy should be started within 12 weeks of surgery (within 2 weeks of enrollment). Chemotherapy should start within 3 weeks of initiating brachytherapy.

Study participation will be up to two years.

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer

Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose Dense Paclitaxel in Patients With High-Risk Endometrial Cancer

Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy

Frequency and severity of adverse events as assessed by the CTCAE v4

Proportion of participants who experienced failure in regional or distant sites

time from study entry to the first tumor recurrence

The contributing cause of death for patients with high risk endometrial cancer

University of Oklahoma

Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles

Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted

Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles

Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma	NCT00165126	Endometrial Car... Cervix Cancer Carcinoma of th...	Radiation thera...	18 Years - 90 Years	Dana-Farber Cancer Institute
Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma	NCT00165126	Endometrial Car... Cervix Cancer Carcinoma of th...	Radiation thera...	18 Years - 90 Years	Dana-Farber Cancer Institute
Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer	NCT03422198	Endometrial Cle... Endometrial End... Endometrial Ser... Stage I Uterine... Stage IA Uterin... Stage IB Uterin... Stage II Uterin... Uterine Corpus ... Uterine Corpus ...	Vaginal Cuff Br... Short course va...	-	University of Utah
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer	NCT03189446	Endometrial Can... Papillary Serou... Clear Cell Endo...	Vaginal Cuff Br... Carboplatin Paclitaxel	18 Years - 99 Years	University of Oklahoma

Spots Global Cancer Trial Database for vaginal cuff brachytherapy