Clinical trial · Interventional
Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer
Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| IMRT | Radiation | — | UNRESOLVED |
| PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- IMRT with concurrent cisplatin 40 mg/m2
- description
- Intensity-modulated Radiation Therapy (IMRT) with concurrent cisplatin 40 mg/m2
- interventionNames
- Drug: Cisplatin
- Radiation: IMRT
- type
- EXPERIMENTAL
- label
- PET-guided Bone Marrow-Sparing IMRT
- description
- PET-guided Bone Marrow-Sparing IMRT with concurrent cisplatin 40 mg/m2
- interventionNames
- Radiation: PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT)
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Primary Event (Acute Hematologic or GI Toxicity)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 \< 1.5 mg/dl; WBC ≥ 3,000/μl; ALT/AST \< 3 x ULN; INR ≤ 1.5 * Negative serum pregnancy test for women of child-bearing potential Exclusion Criteria: * Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; * Prior systemic chemotherapy within the past three years * Prior radiotherapy to the pelvis or abdomen that would result in overlap of radiation therapy fields; * Para-aortic, inguinal, or gross (unresected) pelvic nodal metastasis. Gross pelvic nodal metastasis is defined as either: Radiographic evidence of nodal metastasis on CT or MRI (node having short axis diameter \> 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
References
Publications (0)
Data not yet available