Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer

NCT03189446 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 7964
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Cancer; Papillary Serous; Clear Cell Endometrial Cancer

Keywords

Endometrial Cancer; Gynecologic Cancer; radiation therapy

Outcome Measures

Primary Outcomes (1)

• Number of Patients Completing the Protocol

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

  4 months

Secondary Outcomes (5)

• Frequency of Adverse Events Related to Acute Toxicity During Treatment

  4 months

• Sites of Failure

  up to 2 years

• Recurrence-free Survival

  up to 2 years

• Contributing Cause of Death

  up to 2 years

• Overall Survival

  up to 2 years

Study Arms (1)

Vaginal Cuff Brachytherapy + Chemotherapy

EXPERIMENTAL

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; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Vaginal Cuff Brachytherapy RADIATION

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

Vaginal Cuff Brachytherapy + Chemotherapy

Carboplatin DRUG

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

Vaginal Cuff Brachytherapy + Chemotherapy

Paclitaxel DRUG

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

Vaginal Cuff Brachytherapy + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease). Post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed.
• 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 fitting one of the following high-intermediate risk factor categories:
• age ≥18 years with 3 risk factors
• Risk factors:
• Grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ½ myometrial invasion. Patients with these risk criteria may be enrolled with either positive or negative cytology.
• Patients with Stage II endometrial carcinoma (any histology) with cervical stromal invasion. (occult or gross involvement), with or without high-intermediate risk factors.
• Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible provided the disease is uterine-confined (with or without cervical stromal invasion or endocervical glandular involvement).
• Patients must have GOG performance status 0, 1, or 2.
• Patients must have adequate bone marrow, renal, hepatic and neurologic function per protocol.
• Patients who have met the pre-entry requirements specified in protocol; testing values/results must meet eligibility criteria specified in protocol.
• Patients must have signed an approved informed consent and authorization permitting release of personal health information.

You may not qualify if:

• Patients with recurrent disease.
• Patients with GOG performance status of 3 or 4.
• Greater than 12 weeks elapsed from surgery to enrollment.
• Patients have prior pelvic or abdominal radiation therapy.
• Known hypersensitivity to any component of study treatment that resulted in drug discontinuation.
• Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• Active pregnancy or lactation.
• Prior malignancy requiring treatment within the last 3 years.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Kathleen Moore
• Organization: Stephenson Cancer Center

Kathleen-Moore@ouhsc.edu

405-271-8777

Study Officials

• Kathleen Moore, MD

  Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 16, 2017
• Study Start: October 2, 2017
• Primary Completion: December 13, 2019
• Study Completion: October 6, 2021
• Last Updated: March 8, 2024
• Results First Posted: January 12, 2021

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)