Actively Recruiting
Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix
Led by Varian, a Siemens Healthineers Company · Updated on 2025-09-23
125
Participants Needed
5
Research Sites
434 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, prospective, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for locally advanced cervical cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT). The timepoint for this assessment will be at week 5 of external beam radiotherapy (EBRT) and will use the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
CONDITIONS
Official Title
Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed, newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma), FIGO 2018 stages IB2-IVA without paraaortic lymph node involvement
- Pelvic nodal status confirmed by PET/CT, CT, MRI, fine needle biopsy, extraperitoneal biopsy, or laparoscopic biopsy
- No history of hysterectomy
- Planning to undergo concurrent pelvic radiation and chemotherapy
- ECOG performance status of 2 or less (Karnofsky 60% or greater)
- Willing and able to complete PRO-CTCAE, EQ-5D, EPIC, and EORTC questionnaires
- Normal organ and marrow function meeting specified blood count and chemistry thresholds
- Age 18 years or older (or meets local age of consent)
- Intending to receive standard cisplatin chemotherapy
- Able and willing to sign informed consent
You will not qualify if you...
- Prior radiation therapy to pelvis, abdomen, or para-aortic lymph nodes
- Para-aortic lymph node metastasis
- Prior staging pelvic or para-aortic lymphadenectomy
- Prior allogeneic bone marrow or solid organ transplantation
- Prior systemic anticancer therapy within 3 years
- Synchronous primary malignancy except DCIS breast or early basal cell skin carcinoma
- History of inflammatory bowel disease or other specified autoimmune diseases
- Active tuberculosis infection
- Pregnancy or active breastfeeding
- Child-bearing potential without agreement to use birth control for at least 14 months after cisplatin
- History of vesicovaginal, enterovaginal, or colovaginal fistula
- Pelvic or para-aortic lymph node dissection before planned chemoradiation
- Known active HIV infection
- Presence of hip prosthetics
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of Alabama Birmingham
Burmingham, Alabama, United States, 35233
Actively Recruiting
2
University of Arkansas Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Moores Cancer Center at UC San Diego Health
La Jolla, California, United States, 92037
Actively Recruiting
4
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
5
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
H
Heike Hausen, MD
CONTACT
S
Sean Davidson, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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