Clinical trial · Interventional
Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer
An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was closed because of slow accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. It is not yet known whether chemotherapy and radiation therapy are more effective with or without hyperthermia therapy in treating cervical cancer. PURPOSE: This randomized phase III trial compared the safety and efficacy of cisplatin and radiation therapy, together with hyperthermia therapy versus cisplatin and radiation therapy alone in the treatment of locally advanced cervical cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| external beam radiation therapy | Radiation | — | UNRESOLVED |
| hyperthermia treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients received cisplatin IV and concurrently underwent hyperthermia treatment over 60-90 minutes on day 1. Patients also underwent external beam radiation therapy once daily on days 1-5. Treatment repeated weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity. After completion of chemoradiotherapy and hyperthermia, patients underwent brachytherapy to the cervix for 2-3 days.
- interventionNames
- Drug: cisplatin
- Procedure: hyperthermia treatment
- Radiation: brachytherapy
- Radiation: external beam radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients received cisplatin and undergo external beam radiation therapy (and brachytherapy) as in arm I.
- interventionNames
- Drug: cisplatin
- Radiation: brachytherapy
- Radiation: external beam radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: Invasive cervical carcinoma (squamous, adeno or adenosquamous histologies, small cell histology excluded) * age \>18years * International Federation of Gynecology and Obstetrics ((FIGO) stage IB2, IIA-IVA, FIGO stages IA, IB1 with positive pelvic lymph nodes or parametria either on imaging techniques or pathologically involved at the time of surgery. patients undergoing surgical removal of the cervix and uterus are not eligible, parametria either on imaging techniques or pathologically involved at the time • Performance status Eastern Cooperative Oncology Group(ECOG)/World Health Organisation (WHO) 0, 1 or \>/=70%respectively White Blood count (WBC) ≥ 3,000, platelets ≥ 100,000, Absolute Neutrophil Count (ANC) \> 1500 • serum bilirubin ≤ 1.5 times upper limit of normal, transaminase ≤ 3 times upper limit of normal calculated creatinine clearance \>60milliliters (mls)/liter ( Cockcroft) OR creatinine \</= 2.0mgs% paraaortic adenopathy absent or 1.5 centimeter (cm) in greatest dimension on Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) scan; No history of myocardial infarction in the last 6 months no symptomatic angina pectoris negative pregnancy test in patients under 50 Hemoglobin \>12.0 Gd/dl or \>7.5 mmo;/L with transfusion if needed written written informed consent Exclusion criteria: surgical resection of the primary tumor (i.e. Total abdominal hysterectomy (TAH)/ Bilateral salpingoophorectomy (BSO) * patients with pacemakers or implanted defibrillators * patients with significant metallic foreign bodies (i.e. hip replacements, bone metallic rods,orthopedic plates, etc.) * prior radiotherapy or chemotherapy
References
Publications (0)
Data not yet available