- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00045461
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
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.
연구 개요
상세 설명
OBJECTIVES:
- Compare the time to progressive disease in patients with recurrent ovarian epithelial, fallopian tube, or extraovarian peritoneal cancer treated with carboplatin and ifosfamide with or without whole body hyperthermia.
- Compare the response rate, duration of response, and survival time of patients treated with these regimens.
- Compare the effect on the presence of disseminated tumor cells in bone marrow in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Assess quality of life of patients treated with these regimens.
OUTLINE: This is a phase II safety and efficacy study followed by a phase III randomized, open-label, multicenter study.
- Phase II: Patients receive ifosfamide IV over 1 hour and carboplatin IV over 20 minutes on day 1. Patients also undergo whole body hyperthermia for at least 1 hour on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Phase III (after successful treatment of 15 patients in phase II): Patients are stratified according to disease-free interval (6-12 months vs more than 12 months), measurable disease (bidimensionally measurable vs measurable by other clinical means), and disease recurrence (first recurrence vs second or greater recurrence). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive ifosfamide, carboplatin, and whole body hyperthermia as in phase II.
- Arm II: Patients receive ifosfamide and carboplatin as in arm I.
- In both arms, treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before each course, 4 weeks after the last course, and then every 3 months for 2 years.
Patients are followed at 4 weeks and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for phase II of this study. A total of 226 patients (113 per treatment arm) will be accrued for phase III of this study within 2 years.
연구 유형
등록 (예상)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드, 1105 AZ
- 모병
- Academisch Medisch Centrum at University of Amsterdam
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연락하다:
- Anneke M. Westermann, MD, PhD
- 전화번호: 31-20-566-5955
- 이메일: a.m.westermann@amc.uva.nl
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Berlin, 독일, D-13353
- 모병
- Charite University Hospital - Campus Virchow Klinikum
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연락하다:
- B. Hildebrandt, MD
- 전화번호: 49-30-450-553-636
- 이메일: bert.hildebrandt@chu-ite.de
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Frankfurt, 독일, D-60488
- 모병
- Krankenhaus Nordwest
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연락하다:
- Elke Jaeger, MD
- 전화번호: 49-69-7601-3380
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Hamburg, 독일, D-20246
- 모병
- University Medical Center Hamburg - Eppendorf
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연락하다:
- S. Hegewisch-Becker, MD
- 전화번호: 49-40-428-033-971
- 이메일: hegewisch@uke.uni-hamburg.de
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Luebeck, 독일, D-23538
- 모병
- Universitaets - Kinderklinik - Luebeck
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연락하다:
- A Bakhshandeh-Bath, MD
- 전화번호: 0049-451-500-2316
- 이메일: bakhshan@medinf.mu_luebeck.de
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Trostberg, 독일, D-83308
- 모병
- Kreiskrankenhaus Trostberg
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연락하다:
- A. Biedermann, MD
- 전화번호: 0862-11-87-5020
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Budapest, 헝가리, 1076
- 모병
- Peterfy Korhaz Szulo-Nobeteg Oztaly
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연락하다:
- L. Kornya, MD
- 전화번호: 36-1-322-3450
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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독성
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응답률
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삶의 질
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응답 기간
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생존 시간
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질병 진행 시간
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Effects on the presence of disseminated tumor cells in bone marrow
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공동 작업자 및 조사자
수사관
- 연구 의자: Harald Sommer, MD, Ludwig-Maximilians - University of Munich
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- LMU-DOLPHIN-1
- CDR0000256532 (레지스트리 식별자: PDQ (Physician Data Query))
- EU-20220
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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