Is NCT05197881 recruiting in La Jolla, CA?

Yes, NCT05197881 is currently recruiting participants at its La Jolla, CA location. This cervical cancer by figo stage 2018 clinical trial is actively enrolling qualified participants.

How do I join the cervical cancer by figo stage 2018 clinical trial in La Jolla?

To join this clinical trial in La Jolla, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this La Jolla clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cervical Cancer by FIGO Stage 2018 Clinical Trial in La Jolla, CA

About This Cervical Cancer by FIGO Stage 2018 Study in La Jolla

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).

Sponsor: Varian, a Siemens Healthineers Company

Who Can Participate

Inclusion Criteria

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.

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 care.

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, 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).

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.

Exclusion Criteria

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); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis, multiple sclerosis.).

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in La Jolla?

Yes, this clinical trial (NCT05197881) has an active research site in La Jolla, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cervical Cancer by FIGO Stage 2018 Treatment Options in La Jolla, CA

If you're searching for cervical cancer by figo stage 2018 treatment options in La Jolla, CA, this clinical trial (NCT05197881) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our La Jolla research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cervical cancer by figo stage 2018 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cervical cancer by figo stage 2018 clinical trials near you to find additional studies recruiting in your area.

Cervical Cancer by FIGO Stage 2018 Clinical Trial in La Jolla, CA

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