Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer
A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer
The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer.
Side effects (toxicity) information will also be collected.
연구 개요
상태
정황
상세 설명
Surgical removal has been the standard treatment for operable esophageal cancer. However, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery.
Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).
Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Florida
-
Fort Myers, Florida, 미국, 33901
- Florida Cancer Specialists
-
Jacksonville, Florida, 미국, 32256
- Integrated Community Oncology Network
-
-
Georgia
-
Gainesville, Georgia, 미국, 30501
- Northeast Georgia Medical Center
-
-
Kentucky
-
Louisville, Kentucky, 미국, 40207
- Consultants in Blood Disorders and Cancer
-
-
New Jersey
-
Morristown, New Jersey, 미국, 07960
- Hematology Oncology Associates of Northern NJ
-
-
Ohio
-
Canton, Ohio, 미국, 44710
- Aultman Hospital
-
Cincinnati, Ohio, 미국, 45242
- Oncology Hematology Care
-
-
Tennessee
-
Chattanooga, Tennessee, 미국, 37404
- Chattanooga Oncology Hematology Associates
-
Nashville, Tennessee, 미국, 37023
- Tennessee Oncology, PLLC
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or III
- No prior treatment for esophageal cancer
- Must be surgical candidate based on stage and location of disease
- Measurable or evaluable disease
- Able to be up and perform self care
- Adequate liver, renal function and bone marrow function
- Patients will have to have a central venous access device placed
- Able to give written informed consent.
- Age 18 or older
Exclusion Criteria:
- Stage IV disease
- Prior cancer treatment for advanced cancer in the last 5 years
- Pregnant or lactating women
- History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
- History of neurological disease
- Recent history of blood in the sputum or vomitus
- Non-healing wounds, ulcer or long bone fractures
- History of bleeding problems or coagulation problems
- History of abdominal fistula, gi perforation or intrabdominal abscess within 6 months
- History of uncontrolled hypertension
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
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: Treatment
Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks). Surgery will be performed approximately 12-14 weeks after beginning this combined treatment. |
수술
베바시주맙
다른 이름들:
카보플라틴
다른 이름들:
파클리탁셀
다른 이름들:
Erlotinib
다른 이름들:
5-FU
다른 이름들:
Radiation therapy
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pathologic Complete Response (pCR) Rate
기간: 18 months
|
pCR was defined as no residual viable cancer found at the primary site or regional lymph nodes upon pathologic review of the surgical specimen for patients who went to surgical resection.
|
18 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival
기간: 32 months
|
Overall Survival (OS) is defined as the time interval from the start of treatment until death.
Patients who remained alive were censored at the date of their last tumor assessment.
|
32 months
|
|
Progression-Free Survival
기간: 36 months
|
Progression-free survival (PFS) was defined as the interval from the date of first treatment until the date of disease progression or death, whichever occurred first.
Patients who did not progress were censored at the date of their last tumor assessment.
|
36 months
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: John D Hainsworth, MD, SCRI Development Innovations, LLC
간행물 및 유용한 링크
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 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. .