Hypofractionated Radiochemotherapy

NCT06331468 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-23-GYN-10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the use of hypofractionated radiation (delivery of fewer but larger doses of radiation) with concurrent chemotherapy for women with metastatic of bulky uterine cervix cancer. The main questions it aims to answer are:

• What is the MRI-assessed rate of response at 1-month and 3-months post-treatment?
• What is the safety and tolerability of cisplatin-based hypofractionated pelvic Intensity Modulated Radiation Therapy (IMRT) followed by brachytherapy?
• What is the median progression-free survival and overall survival at 1 and 2 years for patients who undergo cisplatin-based hypofractionated pelvic IMRT?
• What is the proportion of patients who complete the treatment in prescribed timeframe?
• What the levels of cervix cancer circulating tumor cells pretherapy and after treatment? To confirm eligibility, within four weeks prior to study enrollment, all patients will undergo the following:
• Complete history and physical exam, GOG performance status evaluation
• Standard of care scans, which include staging CTs and/or PET scans, and MRI to verify eligibility and appropriate stage of disease. Blood tests will be done to check various organ functions. Treatment will be administered on an outpatient basis. The main difference between the proposed regimen in the trial and standard of care is as follows:
• The trial has a shortened course of EBRT. Standard of care utilizes 25 treatments, also known as "fractions" of EBRT, while the trial utilizes 8 fractions of EBRT. An equivalent "biological effective dose" is achieved by increasing the radiation dose per fraction.
• The concurrent cisplatin dosing is shortened from 5-6 cycles of cisplatin to 2 cycles of cisplatin. The dose of cisplatin is 40 mg/m2.

Conditions

Uterine Cervix Cancer

Keywords

Uterine Neoplasm; Cisplatin

Outcome Measures

Primary Outcomes (1)

• MRI assessed rate of complete response

  MRI-assessed rates of complete response as estimated by the number of CRs (complete response per RECIST v1.1) divided by the total number of evaluable subjects

  1 month post treatment (day 60)

Secondary Outcomes (5)

• MRI assessed rate of complete response

  3 months post treatment (day 120)

• progression-free survival (PFS)

  up to 2 years

• overall survival (OS)

  up to 2 years

• Treatment Completion

  up to 32 days

• Treatment Tolerability

  up to 2 years

Other Outcomes (1)

• Change in levels of uterine cervix cancer circulating tumor cells

  pre-treatment; 1-month post-treatment completion (Day 60); and 3-mos post-treatment completion (Day 120)

Study Arms (1)

Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy

EXPERIMENTAL

Cisplatin two (2) one-time weekly intravenous infusions at 40 mg/m2 (70mg maximum) IMRT once daily, four fractions per week for 2 weeks 4.56 Gy x 8 fractions High dose rate Brachytherapy twice per week with a 2-day break in between sessions for a total of four brachytherapy treatments. The dose is 7 Gy x 4 fractions

Drug: Cisplatin; Radiation: intensity modulated radiation therapy (IMRT); Radiation: high-dose-rate (HDR) brachytherapy

Interventions

intensity modulated radiation therapy (IMRT) RADIATION

given once daily Monday-Thursday, four fractions per week for 2 weeks. The radiation dose is 4.56 Gy x 8 fractions.

Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy

Cisplatin DRUG

A total of two IV infusions of cisplatin will be administered on Day 1 and again on Day 8 +/- 1 day. Cisplatin starting dose is 40 mg/m2. Dose reduction is allowed (30 mg/m2) as needed for management of toxicities.

Also known as: Platinol

Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy

high-dose-rate (HDR) brachytherapy RADIATION

administered 2x weekly (allow at least 72-hours window between sessions); weekdays only for 2 weeks. The radiation dose is 7 Gy x 4 fractions.

Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated, pathologically or cytologically-confirmed diagnosis of FIGO Stage IB3, II, or IIIA-IIIC1 bulky ( ≥ 6cm) or Stage IVA or Stage IVB (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix with limited metastatic burden (not requiring urgent systemic therapy).
• Adequate organ and marrow function
• Gynecologic Oncology Group performance status of 0, 1, or 2
• Patient agrees to use two forms of birth control if they are of child-bearing potential
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Presence of another concurrent active invasive malignancy
• Prior invasive malignancy diagnosed within the last three years, with the following two exceptions: \[a\] non-melanoma skin cancer and/or \[b\] prior in situ carcinoma of the cervix
• Receipt of prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues, at the discretion of the treating physician
• Currently receiving any other investigational agent(s) for the treatment of cancer
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cisplatin or other agents used in study
• Presence of uncontrolled intercurrent illness as determined by the treating physician
• pregnant or lactating
• Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better

Sponsors & Collaborators

• Denise Fabian: lead

Study Sites (1)

Markey Cancer Center

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms

Interventions

Cisplatin; Radiotherapy, Intensity-Modulated; Brachytherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Denise Fabian, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Taul, RN

CONTACT

859-323-2354; yvonne.taul@uky.edu

Denise Fabian, MD

CONTACT

Study Design

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

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: June 26, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)