Phase 3
N=109
Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer
Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01554397 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Primary Event (Acute Hematologic or GI Toxicity) — 55; 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT) (Radiation); Cisplatin (Drug); IMRT (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Diego
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Event (Acute Hematologic or GI Toxicity) |
55; 46 | — |
| SECONDARY Progression-free Survival |
46; 55 | — |
| SECONDARY Acute Adverse Events |
17; 17; 2; 1; 17; 25 | — |
Summary
The purpose of this study is to find out whether patients with cervical cancer treated with PET-guided Bone Marrow Sparing IMRT have less side effects with equal cancer control compared to standard radiation techniques (IMRT). The hypothesis is that PET-guided Bone Marrow Sparing IMRT will reduce acute hematologic and gastrointestinal toxicity and increase chemotherapy tolerance for cervical cancer patients treated with concurrent cisplatin.
Eligibility Criteria
Inclusion Criteria
- Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- Biopsy result positive for carcinoma within 60 days prior to registration
- FIGO clinical stage I-IVA disease, based on standard diagnostic workup, including:History/physical examination and/or Examination under anesthesia (if indicated)
- If the patient is status post hysterectomy, one or more of the following conditions must be present: positive lymph nodes, positive margins, parametrial invasion, or non-radical surgery (i.e., simple hysterectomy).
- If the patient is inoperable, one or more of the following conditions must be present: clinical stage IB2-IVA, positive lymph nodes on nodal sampling or frozen section, and/or parametrial invasion
- Within 42 days prior to registration, the patient must have any of the following, if clinically indicated: examination under anesthesia, cystoscopy, sigmoidoscopy, rigid proctoscopy, or colonoscopy.
- X-ray (PA and lateral), CT scan, or PET/CT scan of the chest within 42 days prior to registration;
- CT scan, MRI, or PET/CT of the pelvis within 42 days prior to registration;
- Karnofsky Performance Status 60-100
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable); Creatinine clearance ≥ 50 mg/dl; Bilirubin 1 cm)OR Radiographic evidence of nodal metastasis on diagnostic FDG-PET or PET/CT scan (abnormally increased FDG uptake as determined and documented by the radiologist)OR Biopsy-proven metastasis (e.g. needle biopsy) in undissected node
- Distant metastasis
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Uncontrolled diabetes, defined as diabetes mellitus, which in the opinion of any of the patient's physicians requires an immediate change in management;
- Uncompensated heart disease or uncontrolled high blood pressure
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition
Data sourced from ClinicalTrials.gov (NCT01554397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.