ClinicalTrials.gov
ClinicalTrials.gov Menu

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial 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: NCT03189446
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
The purpose of this study is to determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Papillary Serous Clear Cell Endometrial Cancer Radiation: Vaginal Cuff Brachytherapy Drug: Carboplatin Drug: Paclitaxel Phase 2

Detailed Description:
All patients will receive radiation therapy. Treatment will be delivered either by LDR or HDR brachytherapy. The treatment plan must be started at the time of enrollment. The vaginal brachytherapy should be started within 4 weeks of surgery (within 2 weeks of enrollment), in order to avoid delays in initiation of systemic therapy, which should start on post-operative day 21. The dose will be prescribed to the vaginal (mucosal) surface as defined at the surface of the applicators. Following vaginal cuff radiation therapy, all patients will receive chemotherapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose Dense Paclitaxel in Patients With High-Risk Endometrial Cancer
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaginal Cuff Brachytherapy + Chemotherapy
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
Radiation: Vaginal Cuff Brachytherapy
Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy

Drug: Carboplatin
Carboplatin (AUC6) on day 1 for 3 cycles

Drug: Paclitaxel
Paclitaxel 80mg/m2 IV over 1 hour on days 1,8 and 15 for 3 cycles




Primary Outcome Measures :
  1. Number of patients able to complete 6 cycles of treatment [ Time Frame: 2 years ]
    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


Secondary Outcome Measures :
  1. Number of participants with treatment related adverse events [ Time Frame: 2 years ]
    To determine the toxicity of vaginal cuff brachytherapy followed by carboplatin and dose dense paclitaxel chemotherapy.

  2. Number of participants who recur in radiation field versus distant recurrence [ Time Frame: 2 years ]
    To determine sites of failure associated with vaginal cuff brachytherapy



Information from the National Library of Medicine

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 to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females have this type of cancer.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is strongly encouraged but not mandatory. Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged. Peritoneal washing are optional. If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment CT/MRI is required. All patients will be staged according to the FIGO 2009 staging system and with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement. Patients with Stage II endometrial carcinoma with cervical stromal invasion. Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible if disease is uterine confined. Adequate bone marrow, renal, hepatic and neurologic function.

Exclusion Criteria:

  • Patients with recurrent disease. Greater than 12 weeks elapsed from surgery to enrollment. Prior pelvic or abdominal radiation therapy. Known hypersensitivity to any component of study treatment. Active pregnancy or lactation. Treatment for prior malignancy in the last 3 years.

Information from the National Library of Medicine

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): NCT03189446


Contacts
Contact: Ingrid Block 405 271-8777 ingrid-block@ouhsc.edu

Locations
United States, Oklahoma
Stephenson Cancer Center, University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Ingrid Block    405-271-8777    ingrid-block@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Lisa Landrum, MD OUHSC

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03189446     History of Changes
Other Study ID Numbers: 7964
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Oklahoma:
Endometrial Cancer
Gynecologic Cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action