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Trial Title:
Hypofractionated Radiochemotherapy
NCT ID:
NCT06331468
Condition:
Uterine Cervix Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Cisplatin
Conditions: Keywords:
Uterine Neoplasm
Cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
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.
Arm group label:
Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy
Other name:
Platinol
Intervention type:
Radiation
Intervention name:
intensity modulated radiation therapy (IMRT)
Description:
given once daily Monday-Thursday, four fractions per week for 2 weeks. The radiation dose
is 4.56 Gy x 8 fractions.
Arm group label:
Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy
Intervention type:
Radiation
Intervention name:
high-dose-rate (HDR) brachytherapy
Description:
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.
Arm group label:
Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy
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:
1. 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.
2. 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.
This protocol requires photon IMRT technique followed by high dose rate (HDR)
brachytherapy. The therapies use focused energy beams to kill cancer cells. Radiation
therapy must be completed within 30 days +/- 2 days of initiation. Computed tomography
simulation with the patient in a head-first laying on back-supine position is required.
MRI-guided treatment planning and image guidance during treatment for motion management
will be used.
IMRT will be given once daily Monday-Thursday, four fractions per week. The
high-dose-rate (HDR) brachytherapy following institutional protocol. Brachytherapy will
be delivered twice per week with a 2-day break in between sessions. A total of four
brachytherapy treatments will be delivered.
After active therapy is completed, treatment-related toxicity will be assessed at the
1-month post-treatment completion visit and again at the 3-month post-treatment
completion. Patients removed from the study for unacceptable adverse events will be
followed until resolution or stabilization of the adverse event(s).
Routine MRI imaging to assess treatment response to radiotherapy is conducted at Day 15.
Treatment response to radiotherapy followed by brachytherapy will be assessed at the 1-
month and 3-months post-treatment completion.
Following the 3-months post-treatment completion, study participants will be followed for
disease progression and survival status until Year 2 post-treatment initiation. NOTE:
Cervical cancer patients are routinely followed (clinical surveillance) every 3-months
during the first two years post-treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Untreated, pathologically or cytologically-confirmed diagnosis of FIGO Stage IB3,
II, or IIIA-IIIC1 bulky ( ≥ 6cm) 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
Exclusion Criteria:
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
120 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Markey Cancer Center
Address:
City:
Lexington
Zip:
40506
Country:
United States
Start date:
November 2024
Completion date:
November 1, 2028
Lead sponsor:
Agency:
Denise Fabian
Agency class:
Other
Source:
University of Kentucky
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06331468