ARTIA-Cervix: Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix
Study Details
Study Description
Brief Summary
This is a single-arm, prospective, Phase II, 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Daily Adaptive External Beam Radiation Therapy Daily adaptive radiation therapy delivered with Varian Ethos treatment system. |
Device: Varian Ethos Adaptive Radiation Therapy
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
|
Outcome Measures
Primary Outcome Measures
- Acute Patient Reported Outcome (PRO) GI Toxicity [End of external beam treatment delivery (week 5)]
GI toxicity as reported by the patient using the gastrointestinal section of the NCI-PRO questionnaire
Secondary Outcome Measures
- Acute PRO Bowel Toxicity [End of external beam treatment delivery (week 5)]
Bowel toxicity as reported with EPIC bowel questionnaire
- Acute PRO Urinary Toxicity [End of external beam treatment delivery (week 5)]
Urinary toxicity as reported with EPIC urinary questionnaire
- Patient Reported Quality by EQ-5D-5L [24 months post treatment]
Quality of life as document with EQ-5D-5L patient reported questionnaire
- Patient Reported Quality by EORTC [24 months post treatment]
Quality of life as document with EORTC patient reported questionnaire
- Disease-free Survival [Enrollment through 2 year follow up]
Disease-free survival at 2 years
- Normal Tissue Complication Probability Model [Enrollment through 2 year follow up]
Develop a normal tissue complication probability (NTCP) model of acute GI toxicity based on true integrated daily dose to the bowel
- Workflow Feasibility [End of external beam treatment delivery]
Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT
- CTCAE Toxicities [Enrollment through 2 year follow up]
Physician reported CTCAE toxicities
Eligibility Criteria
Criteria
Inclusion Criteria:
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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 positive LN.
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Patients must NOT have had a hysterectomy.
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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.
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Patients must be planning to undergo concurrent pelvic radiation and chemotherapy.
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ECOG performance status ≤ 2 (Karnofsky ≥60%).
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Patient must be willing and able to complete the PRO-CTCAE, EQ-5D, EPIC and EORTC questionnaires as described in the study protocol.
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Patient must have normal organ and marrow function as defined below:
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leukocytes ≥ 2,500/mcL
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absolute neutrophil count ≥ 1,500/mcL
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platelets ≥ 100,000/mcL
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hemoglobin ≥ 8 g/dL (can be transfused with red blood cells pre-study)
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total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
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AST(SGOT)/ALT(SGPT) ≤ 3 × ULN
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alkaline phosphatase ≤ 2.5 × ULN
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creatinine < 1.5 mg/dL to receive weekly cisplatin*
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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).
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Age ≥ 18 years.
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No known allergy to cisplatin or compounds of similar biologic composition.
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Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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Prior radiation therapy to the pelvis or abdominal cavity, para-aortic lymph glands (PALN) radiation, or previous therapy of any kind for this malignancy.
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Patients with PALN nodal metastasis.
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Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
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Prior systemic anticancer therapy due to a diagnosis of cancer (e.g., chemotherapy, targeted therapy, immunotherapy) within 3 years prior to entering the study.
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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).
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Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease.
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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.).
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Patients with active tuberculosis (TB).
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Patients who are pregnant.
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Patients who are actively breastfeeding (or who do not agree to discontinue breastfeeding before the initiation of protocol therapy).
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Patients who are of child-bearing potential who do not agree to use birth control in accordance with institution's standard of care.
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Patients with a prior known history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula.
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Patients who undergo a pelvic or para-aortic lymph node dissection prior to planned chemoradiation therapy.
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Patients with active infection of HIV; positive 1 / 2 antibodies.
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Patients with hip prosthetics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | Moores Cancer Center at UC San Diego Health | La Jolla | California | United States | 92037 |
| 3 | University of Texas Southwestern | Dallas | Texas | United States | 75390 |
Sponsors and Collaborators
- Varian, a Siemens Healthineers Company
Investigators
- Principal Investigator: Jyoti Mayadev, MD, University of California, San Diego
- Principal Investigator: Kevin Moore, PhD, University of California, San Diego
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VAR-2021-04