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New treatment option for Cervical Cancer by FIGO Stage 2018
Official title Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix
ClinicalTrials.gov ID: NCT05197881
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients must have histologically confirmed, newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous...
- For patients with involved pelvic lymph nodes, the upper border of the CTV nodal volume may not extend above the confluence of the common iliac...
- Patients must NOT have had a hysterectomy.
- Pelvic nodal status is to be confirmed by one or more of the following studies/procedures: PET/CT scan, CT scan, MR Scan, fine needle biopsy, extra...
- Patients must be planning to undergo concurrent pelvic radiation and chemotherapy.
You likely can't join if
- Prior radiation therapy to the pelvis or abdominal cavity, para-aortic lymph glands (PALN) radiation, or previous therapy of any kind for this...
- Patients with PALN nodal metastasis.
- Patients who have undergone staging pelvic and/or paraaortic lymphadenectomy.
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Prior systemic anticancer therapy due to a diagnosis of cancer (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering...
- Patients diagnosed on imaging or biopsy with a synchronous primary malignancy (with the exception of DCIS of the breast, or early stage basal cell...
See the full eligibility criteria
Who can join
- Patients must have histologically confirmed, newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2018 clinical stages IB2-IVA, without involved...
- For patients with involved pelvic lymph nodes, the upper border of the CTV nodal volume may not extend above the confluence of the common iliac arteries with the aorta (i.e., aortic bifurcation).
- Patients must NOT have had a hysterectomy.
- Pelvic nodal status is to be confirmed by one or more of the following studies/procedures: PET/CT scan, CT scan, MR Scan, fine needle biopsy, extra peritoneal biopsy or laparoscopic biopsy, per institutional standard of...
- Patients must be planning to undergo concurrent pelvic radiation and chemotherapy.
- ECOG performance status ≤ 2 (Karnofsky ≥60%).
- Patient must be willing and able to complete the PRO-CTCAE, EQ-5D, EPIC and EORTC questionnaires as described in the study protocol.
- Patient must have normal organ and marrow function as defined below:
- leukocytes ≥ 2,500/mcL
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 100,000/mcL
- hemoglobin ≥ 8 g/dL (can be transfused with red blood cells pre-study)
- total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ 3 × ULN
- alkaline phosphatase ≤ 2.5 × ULN
- creatinine \< 1.5 mg/dL to receive weekly cisplatin\
- Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if there is no hydronephrosis and the estimated creatinine clearance (CCr) is \>30 ml/min. For the purpose of estimating the CCr...
- Age ≥ 18 years (or meets local age of consent).
- Study participant is already intending to be prescribed a standard of care cisplatin treatment regimen.
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Prior radiation therapy to the pelvis or abdominal cavity, para-aortic lymph glands (PALN) radiation, or previous therapy of any kind for this malignancy.
- Patients with PALN nodal metastasis.
- Patients who have undergone staging pelvic and/or paraaortic lymphadenectomy.
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Prior systemic anticancer therapy due to a diagnosis of cancer (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.
- Patients diagnosed on imaging or biopsy with a synchronous primary malignancy (with the exception of DCIS of the breast, or early stage basal cell carcinoma of the skin).
- Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease.
- Patients with a history of other symptomatic autoimmune disease: rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's Granulomatosis)...
- Patients with active tuberculosis (TB).
- Patients who are pregnant.
- Patients who are actively breastfeeding (or who do not agree to discontinue breastfeeding before the initiation of protocol therapy).
- Patients who are of child-bearing potential who do not agree to use birth control (for a minimum of 14 months after the last dose of cisplatin) in accordance with institution's standard of care.
- Patients with a prior known history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula.
- Patients who undergo a pelvic or para-aortic lymph node dissection prior to planned chemoradiation therapy.
- Patients with known active infection of HIV.
- Patients with hip prosthetics
The study team makes the final eligibility decision.
Where it's taking place
- Burmingham, Alabama, United States
- Little Rock, Arkansas, United States
- La Jolla, California, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Burmingham, Alabama, United States; Little Rock, Arkansas, United States; La Jolla, California, United States; Philadelphia, Pennsylvania, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.