Clinical trial · Interventional
Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
A Randomized Phase II/III Trial Comparing Carboplatin-Ifosfamide (IC)-Chemotherapy Vs. IC-Chemotherapy Combined With Extreme Whole Body Hyperthermia In Patients With Recurrence Of Epithelial Ovarian Carcinoma: DOLPHIN-1-STUDY
- 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy is more effective with or without whole-body hyperthermia therapy in treating gynecologic cancer. PURPOSE: Randomized phase II/III trial to compare the effectiveness of chemotherapy with or without whole-body hyperthermia in treating patients who have recurrent ovarian epithelial, fallopian tube, or peritoneal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| hyperthermia treatment | Procedure | — | UNRESOLVED |
| ifosfamide | Drug | Ifosfamide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- Time to progressive disease
- measure
- Response rate
- measure
- Duration of response
- measure
- Survival time
- measure
- Effects on the presence of disseminated tumor cells in bone marrow
- measure
- Toxicity
- measure
- Quality of life
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial, fallopian tube, or extraovarian peritoneal cancer * Recurrent disease (any FIGO stage) * Not amenable to curative surgery or radiotherapy alone * Failed prior primary platinum-based therapy at least 6 months after therapy discontinuation * Measurable lesion by CT scan, MRI, chest x-ray, or sonography * Physical examination allowed for documenting lymph node and skin metastases * Physical gynecological examination allowed for well-defined palpable tumor lesions * Increase in CA 125 without any measurable tumor is not acceptable as indication of recurrence * No CNS metastases * No tumor of borderline malignancy PATIENT CHARACTERISTICS: Age * 18 to 65 Performance status * ECOG 0-2 Life expectancy * At least 24 weeks Hematopoietic * Neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic * Not specified Renal * Creatinine clearance at least 60 mL/min * No chronic or acute renal failure Cardiovascular * Cardiovascular function sufficient for hyperthermia treatment by stress-ECG * No cardiomyopathy with impaired ventricular function * No New York Heart Association class III or IV heart disease * No cardiac arrhythmias influencing LVEF and requiring medication * No myocardial infarction or angina pectoris within the past 6 months * No uncontrolled arterial hypertension Pulmonary * Pulmonary function sufficient for hyperthermia treatment by pulmonary function tests Other * No untreated endocrinological disease (e.g., hyperthyroidism or diabetes mellitus) * No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer * No contraindication against hyperthermia treatment (e.g., photodermatosis, history of malignant hyperthermia, or claustrophobia) * No hypersensitivity to carboplatin, ifosfamide, or any other study medication * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No concurrent cytotoxic or other antineoplastic therapy Endocrine therapy * Concurrent hormone replacement therapy allowed * Concurrent steroid antiemetics allowed Radiotherapy * See Disease Characteristics * At least 1 year since prior radiotherapy (tumoricidal dose) of the pelvis * Concurrent palliative local radiotherapy for painful (nonprogressive) existing lesion is allowed if other measurable sites are present * No concurrent radiotherapy to a second existing lesion Surgery * See Disease Characteristics Other * No prior form of hyperthermic therapy * At least 3 weeks since other medications as part of another clinical study * At least 3 weeks since prior investigational agents * At least 6 weeks since prior betablockers * No concurrent photosensitizing drugs * No concurrent betablockers * No other concurrent anticancer therapy
References
Publications (0)
Data not yet available