Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
2017년 12월 3일 업데이트: Masonic Cancer Center, University of Minnesota
Phase II Pilot Study of TPF (Docetaxel, Cisplatin, and 5-FU) Induction Chemotherapy Followed by Concurrent Cisplatin and Reduced Dose Radiation in Locally Advanced Head and Neck Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.
연구 개요
상태
종료됨
정황
상세 설명
OBJECTIVES:
Primary
- Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by cisplatin and reduced-dose radiotherapy.
Secondary
- Determine the progression-free, disease-free, and overall survival of patients treated with this regimen.
- Determine the pattern of failure in patients treated with this regimen.
- Evaluate the quality of life of patients treated with this regimen.
- Assess pre- and post-treatment swallowing ability of patients and the impact on their quality of life.
Tertiary
- Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
- Evaluate the quality of saliva by examining total protein concentrations.
- Quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8, and vascular endothelial growth factor) in the saliva of these patients.
- Determine the degree of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
- Compare salivary flow rates with the grade of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
OUTLINE: This is a pilot study.
- Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day 5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial or clinical complete response proceed to chemoradiotherapy 3 weeks later.
- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5 days a week for 6 weeks.
- Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with residual neck disease or disease initially staged at N2 or greater undergo neck dissection.
Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8 and vascular endothelial growth factor); and examine the grade of mucositis and xerostomia.
Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year.
After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
연구 유형
중재적
등록 (실제)
4
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- Masonic Cancer Center at University of Minnesota
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
Histologically confirmed squamous cell carcinoma of the head and neck
Stage IVA or IVB disease
- Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery
- Measurable or evaluable disease
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min
- Bilirubin normal
Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:
- AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
Exclusion Criteria:
- Salivary gland, sinus, or nasopharyngeal primary disease
- Evidence of distant metastatic disease
- Pregnant or nursing
- Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
- Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
- Peripheral neuropathy ≥ grade 2
- Hearing loss ≥ grade 2
- Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs
- Poor nutritional status, in the opinion of the investigator
- Active infection
- Active ischemic heart disease
- Myocardial infarction within the past 6 months
- Prior radiotherapy above the clavicles
- Prior chemotherapy
- Prior surgery to the primary tumor except biopsy
- Concurrent amifostine or other investigational agents
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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: Chemotherapy + Low Dose Radiation
Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.
|
subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
다른 이름들:
If applicable on day 5, repeating every 3 weeks for 2 courses.
다른 이름들:
Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
다른 이름들:
Intravenous over 1 hour on day 1.
다른 이름들:
Intravenous continuously on days 1-4.
다른 이름들:
As appropriate, neck dissection.
다른 이름들:
60 Gy 5 days/week x 6 weeks with cisplatin
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Patients With Feeding Tube Dependency
기간: at 12 months
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All patients were non-evaluable and study was terminated early.
There is no measure of outcome.
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at 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Days With Progression-free Survival
기간: Between date of registration to date of first treatment failure or death.
|
All patients were non-evaluable and study was terminated early.
There is no measure of outcome.
Utilizing RECIST criteria.
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Between date of registration to date of first treatment failure or death.
|
|
Number of Days - Overall Survival
기간: Between date of registration to date of death.
|
All patients were non-evaluable and study was terminated early.
There is no measure of outcome.
Utilizing RECIST criteria.
|
Between date of registration to date of death.
|
|
Number of Days With Disease Free Survival
기간: From Date of Registration to Date of First Treatment Failure or Death
|
All patients were non-evaluable and study was terminated early.
There is no measure of outcome.
RECIST criteria measurement.
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From Date of Registration to Date of First Treatment Failure or Death
|
|
Time to Treatment Failure
기간: Number of Days from Complete or Partial Response to First Date of Recurrence or Progression
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All patients were non-evaluable and study was terminated early.
There is no measure of outcome.
Measure using RECIST criteria.
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Number of Days from Complete or Partial Response to First Date of Recurrence or Progression
|
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Swallowing Ability - Quality of Life Scores
기간: Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.
|
All patients were non-evaluable and study was terminated early.
There is no measure of outcome.
Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).
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Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.
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Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire
기간: baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year
|
All patients were non-evaluable and study was terminated early.
There is no measure of outcome.
|
baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Frank G. Ondrey, MD, PhD, Masonic Cancer Center, University of Minnesota
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2006년 3월 1일
기본 완료 (실제)
2008년 4월 1일
연구 완료 (실제)
2008년 4월 1일
연구 등록 날짜
최초 제출
2006년 7월 13일
QC 기준을 충족하는 최초 제출
2006년 7월 13일
처음 게시됨 (추정)
2006년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 12월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 12월 3일
마지막으로 확인됨
2017년 12월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2005LS012
- UMN-0502M67486
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. .