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New radiation technique aims to spare cervical cancer patients from gut woes

NCT ID NCT05197881

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This trial tests a new type of radiation therapy for cervical cancer that adjusts the beam daily based on the patient's anatomy. The goal is to reduce acute bowel side effects like diarrhea and urgency. About 125 patients with advanced cervical cancer will receive this treatment, and their reported side effects will be compared to historical rates from standard radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Daily adaptive external beam radiation therapy delivered via Varian Ethos system
What this could lead to
If successful, this approach could reduce acute gastrointestinal side effects like diarrhea and urgency during radiation for cervical cancer, making treatment more tolerable.
What could go wrong
This is an early-phase, single-arm study comparing results to historical data, not a randomized trial. The new technique may not significantly reduce side effects or could have unforeseen issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 paraaortic lymph nodes. 2. 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). 3. Patients must NOT have had a hysterectomy. 4. 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 care. 5. Patients must be planning to undergo concurrent pelvic radiation and chemotherapy. 6. ECOG performance status ≤ 2 (Karnofsky ≥60%). 7. Patient must be willing and able to complete the PRO-CTCAE, EQ-5D, EPIC and EORTC questionnaires as described in the study protocol. 8. 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, the formula of Cockcroft and Gault for females should be used:CCr=(0.85 ×(140-age)×IBW)/((Scr×72)) where age is the patient's age in years (from 20 to 80 years), Scr is the serum creatinine in mg/dL, and IBW is the ideal body weight in kg (according to the calculation IBW = 45.5 kg + 2.3 kg for each inch over 5 feet). 9. Age ≥ 18 years (or meets local age of consent). 10. Study participant is already intending to be prescribed a standard of care cisplatin treatment regimen. 11. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Prior radiation therapy to the pelvis or abdominal cavity, para-aortic lymph glands (PALN) radiation, or previous therapy of any kind for this malignancy. 2. Patients with PALN nodal metastasis. 3. Patients who have undergone staging pelvic and/or paraaortic lymphadenectomy. 4. Prior allogeneic bone marrow transplantation or prior solid organ transplantation. 5. Prior systemic anticancer therapy due to a diagnosis of cancer (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study. 6. 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). 7. Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease. 8. 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); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis, multiple sclerosis.). 9. Patients with active tuberculosis (TB). 10. Patients who are pregnant. 11. Patients who are actively breastfeeding (or who do not agree to discontinue breastfeeding before the initiation of protocol therapy). 12. 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. 13. Patients with a prior known history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula. 14. Patients who undergo a pelvic or para-aortic lymph node dissection prior to planned chemoradiation therapy. 15. Patients with known active infection of HIV. 16. Patients with hip prosthetics

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Moores Cancer Center at UC San Diego Health

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Alabama Birmingham

    RECRUITING

    Burmingham, Alabama, 35233, United States

  • University of Arkansas Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75390, United States

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