A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

A Feasibility Study of Integrated Delivery of Hypofractionated Pelvic IMRT With Carboplatin and Paclitaxel in Stage III Copy-Number Low and Copy-Number High Subtypes of Endometrial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691010
• Other study ID #: 22-405
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 10, 2023
• Est. completion date: January 10, 2025

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kaled Alektiar, MD
• Phone: 212-639-7981
• Email: alektiak[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out whether short-course radiation therapy (1 week instead of the usual 5 weeks) with chemotherapy (carboplatin and paclitaxel) is practical (feasible), meaning that most participants are able to complete the treatment schedule.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: January 10, 2025
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have newly diagnosed endometrial carcinoma. The following histologic subtypes are eligible for inclusion: endometrioid, serous, clear cell, dedifferentiated/undifferentiated, mixed epithelial, adenocarcinoma not otherwise specified, and carcinosarcoma.

• Surgery must have included a hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node surgical assessment (sentinel lymph node mapping and/or sampling). Para-aortic lymph node surgical assessment is optional.

• Patients must have FIGO (2009) stage IIIA or IIIC1 disease (as determined by surgical staging).

• Patients must consent to testing with MSK-IMPACT part A and are encouraged to consent to both parts A and C.

• Age = 18 years.

• Patients must have an Karnofsky Performance Status (KPS) = 70 (or ECOG 0 or 1).

• Neurologic function: Neuropathy (sensory and motor) grade = 1.

• No residual gross disease after surgery.

• No prior radiation therapy or chemotherapy for treatment of endometrial cancer.

• No active infection requiring antibiotics, except for uncomplicated urinary tract infection.

• Patients must have adequate organ function, defined by the following laboratory results no more than 14 days prior to first study treatment:

• Absolute neutrophil count (ANC) = 1500/mcL

• Platelet count = 100,000/mcL

• AST/ALT = 3X upper limit of normal (ULN)

• Total bilirubin = 1.5X ULN. Patients with known Gilbert's disease and a total bilirubin = 3X ULN may be enrolled.

• Creatinine = 1.5X ULN

• Entry into study is limited to no more than 12 weeks from the date of surgery.

• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

• Patients of childbearing age will by definition have undergone hysterectomy and bilateral oophorectomy prior to study enrollment.

• Participants must agree not to breastfeed during the study or for 150 days after the last dose of study treatment.

Exclusion Criteria:

• Patients whose endometrial cancers harbor known pathogenic POLE mutations

• Patients whose endometrial cancers are mismatch repair deficient, as determined by immunohistochemical staining for MLH1, PMS2, MSH2, and MSH6 and/or MSI-H

• Active inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.

• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. This includes but is not limited to: uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, and superior vena cava syndrome.

• Patients unfit for pelvic radiation therapy due to the following:

• Has had radiation therapy encompassing >20% of the bone marrow within 2 weeks, or any radiation therapy within 1 week prior to day 1 of protocol therapy

• Patients with a history of pelvic radiation.

• Patients with a history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula.

• Any hematological abnormality or disorder that would be a contraindication to radiation per the treating physician.

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Cancer
• Endometrial Carcinoma
• Endometrial Neoplasms
• Stage III Endometrial Carcinoma

Intervention

Radiation:
• Intensity-modulated radiation therapy
After cycles 1, 2, 3 or 4 of chemotherapy, patients will receive IMRT to the vaginal cuff and pelvic lymph nodes with a total dose of 25 Gy delivered in 5 daily fractions of 5 Gy

Drug:
• Carboplatin
Patients enrolled in this trial will receive chemotherapy with carboplatin IV AUC 5 at the discretion of the treating investigator plus paclitaxel 175 mg/m2 every 21 days for 6 cycles
• Paclitaxel
Patients enrolled in this trial will receive chemotherapy with carboplatin IV AUC 5 at the discretion of the treating investigator plus paclitaxel 175 mg/m2 every 21 days for 6 cycles

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All protocol activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (All protocol activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All protocol activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (All protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All protocol activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (All protocol activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of integrated delivery of short-course IMRT with carboplatin/paclitaxel in patients with stage III endometrial cancer	Feasibility of study treatment is defined as defined as the number of participants who complete all 6 planned cycles of carboplatin and paclitaxel with no delays in chemotherapy cycles greater than 21 days.	up to 3 years

External Links

•   Memorial Sloan Kettering Cancer Center