Clinical trial · Interventional
Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer
A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS
- 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)
This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
Conditions
Conditions (7)
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 Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-Dimensional Conformal Radiation Therapy | Radiation | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Topotecan Hydrochloride Liposomes | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (topotecan hydrochloride, radiation, cisplatin)
- description
- Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Topotecan Hydrochloride Liposomes
- Radiation: 3-Dimensional Conformal Radiation Therapy
- Drug: Cisplatin
Primary outcomes (2)
- measure
- Incidence of patients with acute toxicity assessed by Common Terminology Criteria for Adverse Events version 3.0
- timeFrame
- Up to 30 days after completion of radiation therapy
- measure
- Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (CTC RTOG/EORTC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary invasive carcinoma of the uterine cervix * Stages IB2, II, IIIB, and IVA disease * Any cell type * No known metastasis to scalene nodes or organs outside the radiation field * No known intraperitoneal metastases * No evidence of extrapelvic disease based on negative CT or PET scan * Must enroll within 8 weeks of diagnosis * Performance status - GOG 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Creatinine normal * Creatinine clearance \> 50 mL/min * Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed * No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except nonmelanoma skin cancer * No septicemia or severe infection * No other medical or psychiatric condition that would preclude study compliance * No prior chemotherapy for any prior malignancy * No prior cytotoxic chemotherapy for this malignancy * No prior radiotherapy for any prior malignancy * No prior pelvic or abdominal radiotherapy for this malignancy * No prior therapy for this malignancy
References
Publications (0)
Data not yet available