Radiation Therapy and Concurrent Cisplatin Chemotherapy for Locally Advanced or Metastatic Malignant Melanoma
A Prospective Phase II Study of Radiation Therapy and Concurrent Cisplatin Chemotherapy in the Treatment of Locally Advanced or Metastatic Malignant Melanoma
연구 개요
상세 설명
This is a phase II, prospective trial designed to determine the response rate achieved with cisplatin delivered concurrent with radiation therapy in locally advanced or metastatic melanoma.
Radiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments). Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation). Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians).
If the patient's tumor has inadequate response to chemoradiation then salvage therapies can be used as deemed appropriate by the treating physicians. In order to allow adequate response to radiation therapy, salvage therapies will not be utilized until at least 4 weeks following chemoradiation unless deemed emergent by the treating physicians.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Utah
-
Salt Lake City, Utah, 미국, 84112
- Huntsman Cancer Institute
-
Salt Lake City, Utah, 미국, 84143
- LDS Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- Signed study-specific consent form prior to registration.
- Pathologically confirmed malignant melanoma.
- Measurable melanoma lesion deemed to require radiation by treating physicians for purposes of local control or palliation. The lesion may be the primary melanoma, a nodal metastasis, or a distant metastasis. Recurrent lesions are allowed.
- Lesion has to be measurable clinically or radiographically in 2 dimensions.
- Karnofsky Performance Scale (KPS) > 70.
Laboratory values
- White blood cells (WBC) > 3000/mm3
- Absolute granulocyte count > 1,500
- Platelets > 100,000/mm3
- Total bilirubin < 2.0 x institutional upper limit of normal
- AST or ALT (aminotransferase/alanine aminotransferase) < 2.5 x institutional upper limit of normal
- Serum calcium < 1.3 x institutional upper limit of normal
- Serum creatinine < 1.5 mg/dL or Creatinine clearance > 50 cc/min,calculated as follows: CCr = 0.85 x (140-age) x (weight in kg) 72 x serum creatinine in mg/dL
Exclusion criteria:
- Systemic therapy for malignant melanoma within one month preceding trial enrollment.
- Prior irradiation to the planned field.
- Concomitant chemotherapy (in addition to cisplatin) or biologic therapy is allowed.
- Significant infection or other co-existent medical condition which would prevent the use of full dose chemotherapy.
- Pre-existing sensory neuropathy (CTC 3.0 ≥ Grade II)
- Pregnancy or lactation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 모든 참가자
|
Radiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments).
Cisplatin dose will be 100 mg/m2 given i.v.
every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
다른 이름들:
Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation).
Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians).
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Response Rate of Melanoma Lesions
기간: 2005-2010
|
Response rate of melanoma lesions was measured after treated with the trial agent.
|
2005-2010
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Dennis Shrieve, MD, Huntsman Cancer Institute
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HCI15461
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
Radiation Therapy에 대한 임상 시험
-
Alpha Tau Medical LTD.European Organisation for Research and Treatment of Cancer - EORTC아직 모집하지 않음
-
Alpha Tau Medical LTD.모병
-
Alpha Tau Medical LTD.모병
-
Alpha Tau Medical LTD.모집하지 않고 적극적으로