- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00055965
Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
A Pragmatic, Randomised Study To Compare The Hospitalisation Rates Of Two Platinum-Based Outpatient Regimens (Gemcitabine/Cisplatin vs. Gemcitabine/Carboplatin) In Non-Small Cell Lung Cancer (NSCLC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if one regimen will require patients to spend more time in the hospital than the other regimen for treatment of chemotherapy-related side effects.
PURPOSE: Randomized phase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer.
연구 개요
상세 설명
OBJECTIVES:
- Compare the rates of overnight hospitalization due to toxicity (e.g., blood transfusion, antibiotic use, and to obtain relief of treatment-related symptoms) of patients with non-small cell lung cancer treated with gemcitabine and cisplatin vs gemcitabine and carboplatin.
- Compare the need for hospitalization for chemotherapy administration in patients treated with these regimens.
- Compare the tumor response rate of patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the relief of tumor-related symptoms in patients treated with these regimens.
- Compare the effect on Karnofsky performance status in patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIIA vs IIIB [dry] vs IIIB [wet] or IV) and performance status (50-60% vs 70-100%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1-2 hours on days 1 and 8.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1.
In both arms, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 6 months and then every 3-4 months thereafter.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
England
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Manchester, England, 영국, M20 4BX
- Christie Hospital NHS Trust
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed inoperable non-small cell lung cancer
- Stage IIIA, IIIB, or IV
- Not eligible for curative radiotherapy or surgery
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 50-100%
Life expectancy
- At least 12 weeks
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present)
Renal
- Creatinine no greater than ULN OR
- Creatinine clearance at least 60 mL/min
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after study completion
- No active infection
- No serious systemic disorder that would preclude study participation
- No grade 2 or greater peripheral neuropathy
- No significant neurological problems (e.g., seizures or psychiatric disorders)
- No other active malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior cytotoxic chemotherapy
- No other concurrent chemotherapy during or for 7 days after study therapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy
- No concurrent radiotherapy during or for 7 days after study therapy
Surgery
- See Disease Characteristics
Other
- At least 12 weeks since prior investigational agents
- No other concurrent antitumor therapy
- No concurrent experimental medications
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
---|
Rate of hospitalization due to toxicity
|
2차 결과 측정
결과 측정 |
---|
전반적인 생존
|
종양 반응률
|
Need for hospitalization for chemotherapy administration
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Relief of tumor-related symptoms
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Effect on Karnofsky performance status
|
Toxicity as measured by NCIC CTC v2.0
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000271903
- CHNT-GEM-HOSP
- EU-20245
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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