- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05044117
Single-agent Capecitabine as Metronomic Chemotherapy in LAHNSCC (CMHN)
Single-agent Capecitabine as Metronomic Chemotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (CMHN):A Phase III, Multicentre, Randomised Controlled Trial
연구 개요
상세 설명
The standard treatment for resectable locoregionally advanced squamous cell carcinoma of the head and the neck (LAHNSCC) is a regimen consisting of radical surgery plus radiotherapy or concurrent chemoradiotherapy. And induction chemotherapy plus radical radiotherapy or concurrent chemoradiotherapy is also recommended for locoregionally advanced squamous cell carcinoma of larynx and hypopharynx. With the extensive application of comprehensive treatment, the 5-year overall survival of LAHNSCC has not reached 50% yet. So, it is urgent to explore a regimen with high efficiency and low toxicity on the basis of existing standard treatment.
Two retrospective studies found that the metronomic use of orally administered fluorouracil drugs following the reference treatment significantly improved prognosis in LAHNSCC. And capecitabine is one kind of the oral fluorouracil drugs, which has high efficiency and low toxicity. Indeed, metronomic capecitabine maintenance was shown to be effective in patients with breast cancer, colorectal cancer, and nasopharyngeal carcinoma in phase III trials.
The abovementioned studies suggested the promising use of metronomic capecitabine in LAHNSCC. However, there has been no randomized trials in this field. Therefore, we initiated a randomized phase III trial to investigate the efficacy and safety of the addition of metronomic capecitabine to the standard treatment in LAHNSCC.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Ying Sun, M.D.
- 전화번호: +86-(020)-87343816
- 이메일: sunying@sysucc.org.cn
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국, 510060
- 모병
- Sun Yat-sen University Cancer Center
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연락하다:
- Ying Sun, M.D.
- 전화번호: +86-(020)-87343816
- 이메일: sunying@sysucc.org.cn
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Performance status of ECOG grade 0 or 1.
- Tumor staged as III-IV (as defined by the 8th AJCC edition), with newly histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, larynx or hypopharynx.
Complete one of the following treatments:
- Radical surgery plus radiotherapy or concurrent chemoradiotherapy
- Neoadjuvant therapy plus radical radiotherapy or concurrent chemoradiotherapy
- Concurrent chemoradiotherapy
- Postoperative radiotherapy started within 4 to 8 weeks after completion of radical surgery.
- Within 4 to 8 weeks after completion of the last radiation dose.
- No clinical evidence of persistent locoregional disease or distant metastases before enrollment.
- Adequate hematologic (neutrophil count > 1.5×10^9/L, hemoglobin > 90g/L and platelet count > 100×10^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase ≤ 2.5×ULN) and renal function (creatinine clearance ≥ 50 ml/min).
- Patients must be appraised of the investigational nature of the study and provide written informed consent.
Exclusion Criteria:
- p16 positive.
- Patients who were known to be intolerable or allergic to capecitabine.
- Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- Prior surgery, chemotherapy, radiotherapy or other anti-tumor treatments (except diagnostic) to primary tumor or nodes before the standard therapy.
- Patients who received surgery treatment, biotherapy or immunotherapy during radiotherapy.
- Patients who are receiving or highly likely to receive other chemotherapy treatment, biotherapy or immunotherapy after radiotherapy.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Clinical observation
The standard treatment followed by clinical observation.
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실험적: Metronomic capecitabine
The standard treatment followed by a maintenance therapy with capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year.
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Metronomic capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Progression-free survival
기간: 2 years
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PFS will be measured from the day of randomization until treatment failure, death from any cause, or the last follow-up visit, whichever occurred first.
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall survival
기간: 2 years
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OS will be measured from the day of randomization until death due to any cause, or the last follow-up visit.
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2 years
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Distant failure-free survival
기간: 2 years
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DFFS will be measured from the day of randomization until death until distant metastasis, or the last follow-up visit.
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2 years
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Locoregional failure-free survival
기간: 2 years
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LRFFS will be measured from the day of randomization until death until local and/or regional recurrence, or the last follow-up visit.
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2 years
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Adverse events
기간: Up to 2 years
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The incidence of capecitabine-related and other adverse events.
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Up to 2 years
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Patient reported quality-of-life score
기간: Up to 2 years
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Patient reported quality of life would be evaluated using the Quality of Life Questionnaire-Core 30 module (QLQ-C30).
The score is between 0-100, and the higher score means worse quality of life.
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Up to 2 years
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공동 작업자 및 조사자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- CMHN
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Capecitabine에 대한 임상 시험
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Hebei Medical University알려지지 않은
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Assistance Publique - Hôpitaux de Paris모집하지 않고 적극적으로