Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
PHASE II STUDY ON LARYNX PRESERVATION COMPARING INDUCTION CHEMOTHERAPY AND RADIOTHERAPY VERSUS ALTERNATING CHEMO-RADIOTHERAPY IN RESECTABLE HYPOPHARYNX AND LARYNX CANCERS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known which regimen of cisplatin and fluorouracil combined with radiation therapy is more effective in treating resectable cancer of the hypopharynx or larynx.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of cisplatin and fluorouracil combined with radiation therapy in preserving the larynx in patients who have resectable cancer of the hypopharynx or larynx.
연구 개요
상세 설명
OBJECTIVES:
- Compare relapse-free survival and larynx preservation in patients with resectable hypopharyngeal or laryngeal cancer treated with sequential vs alternating cisplatin and fluorouracil and radiotherapy.
- Compare the health-related quality of life in patients treated with these regimens.
- Compare the cost-effectiveness of these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by performance status, disease site, tumor stage, node stage, and center.
Patients are randomized to one of two treatment arms. Both groups may receive either conventional radiotherapy in single daily fractions, 5 days per week, for 7 weeks (option 1) or hyperfractionated radiotherapy in 2 daily fractions, 5 days per week, for 4-5 weeks (option 2), according to institutional policy.
- Arm I: Patients receive cisplatin and fluorouracil every 3 weeks. Patients with a complete or partial response on day 42 receive 2 additional courses of chemotherapy followed by 7 weeks of radiotherapy beginning on day 80. After radiotherapy, patients with a complete remission enter follow-up; those with a partial remission proceed to surgery. Patients with stable or progressive disease proceed immediately to surgery with or without postoperative radiotherapy.
- Arm II: Patients receive cisplatin and fluorouracil every 3 weeks for 4 courses. Patients treated on radiotherapy option 1 are evaluated 2 months after completion of radiotherapy; those with a complete remission enter follow-up while all others proceed to surgery. Patients treated on option 2 are evaluated on day 42; those with a partial or complete response complete chemoradiotherapy and are then evaluated and treated like option 1 patients. Patients with stable or progressive disease on day 42 proceed to surgery with or without a third course of chemotherapy on week 7.
Patients are followed every 3 months for 3 years and at least every 6 months thereafter.
PROJECTED ACCRUAL: A total of 564 patients will be accrued for this study within 4 years.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
-
Amsterdam, 네덜란드, 1007 MB
- Vrije Universiteit Medisch Centrum
-
Leiden, 네덜란드, 2300 CA
- Leiden University Medical Center
-
Maastricht, 네덜란드, 6202 AZ
- Academisch Ziekenhuis Maastricht
-
-
-
-
-
Antwerp, 벨기에, 2020
- Algemeen Ziekenhuis Middelheim
-
Edegem, 벨기에, B-2650
- Universitair Ziekenhuis Antwerpen
-
-
-
-
-
Lausanne, 스위스, CH-1011
- Centre Hospitalier Universitaire Vaudois
-
-
-
-
-
Haifa, 이스라엘, 31096
- Rambam Medical Center
-
-
-
-
-
Milano (Milan), 이탈리아, 20133
- Istituto Nazionale per lo Studio e la Cura dei Tumori
-
Monselice, Padova, 이탈리아, 35043
- Ospedale Civile Monselice
-
Pordenone, 이탈리아, 33170
- Azienda Ospedaliera "Santa Maria Degli Angeli"
-
-
-
-
-
Besancon, 프랑스, 25030
- CHR de Besancon - Hopital Jean Minjoz
-
Caen, 프랑스, 14076
- Centre Regional Francois Baclesse
-
Dijon, 프랑스, 21033
- Centre Hospitalier Universitaire de Dijon
-
Dijon, 프랑스, 21079
- Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
-
Lille, 프랑스, 59020
- Centre Oscar Lambret
-
Lille, 프랑스, 59037
- Centre Hospitalier Regional et Universitaire de Lille
-
Nantes-Saint Herblain, 프랑스, 44805
- CRLCC Nantes - Atlantique
-
Nice, 프랑스, 06189
- Centre Antoine Lacassagne
-
Rouen, 프랑스, 76031
- Hôpital Charles Nicolle
-
Vandoeuvre-les-Nancy, 프랑스, 54511
- Centre Alexis Vautrin
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically proven squamous cell carcinoma of the head and neck, including:
Stage III/IV cancer of the glottic or supraglottic larynx
Eligible T4 tumor defined as:
- Bulging the valleculae
- Bulging the hyothyroid membrane
- Minimal thyroid cartilage invasion or suspicion of invasion on imaging
Stage II/III/IV cancer of the pyriform sinus or of the hypopharyngeal aspect of the aryepiglottic fold (with or without extension to postcricoid area)
- No massive destruction of the thyroid cartilage
- No continuity between primary tumor and a lymph node
Operable on first attempt (as assessed by head and neck surgeon) by classical total laryngectomy with or without partial pharyngectomy
- No requirement for extended surgery (circumferential pharyngolaryngectomy)
- No tumor suitable for partial (functional) surgery or requiring extended surgery that necessitates any kind of flap for closure
- No N2c tumor unless no requirement for bilateral resection of internal jugular veins
Measurable or evaluable disease by panendoscopy and CT scan or MRI
- Esophagoscopy required
- Bronchofiberscopy recommended
- No requirement for tracheotomy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2 OR
- WHO 0-2
Hematopoietic:
- WBC at least 4,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Other:
- No medical, psychological, or geographical condition that precludes study compliance
- No serious nonmalignant systemic disease
No second malignancy except:
- Carcinoma in situ of the cervix
- Adequately treated nonmelanomatous skin cancer
- No poor nutritional status unlikely to be restored to fair status within 3 weeks
- No contraindication to CT scan or general anesthesia
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior anticancer biologic therapy
Chemotherapy
- No prior anticancer chemotherapy
Endocrine therapy
- No prior anticancer endocrine therapy
Radiotherapy
- No prior anticancer radiotherapy
Surgery
- See Disease Characteristics
Other
- No other prior anticancer therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
공동 작업자 및 조사자
수사관
- 연구 의자: Jean-Louis Lefebvre, MD, Centre Oscar Lambret
- 연구 의자: Jean-Claude Horiot, MD, PhD, Centre Georges François Leclerc
간행물 및 유용한 링크
일반 간행물
- Lefebvre JL, Rolland F, Tesselaar M, Bardet E, Leemans CR, Geoffrois L, Hupperets P, Barzan L, de Raucourt D, Chevalier D, Licitra L, Lunghi F, Stupp R, Lacombe D, Bogaerts J, Horiot JC, Bernier J, Vermorken JB; EORTC Head and Neck Cancer Cooperative Group; EORTC Radiation Oncology Group. Phase 3 randomized trial on larynx preservation comparing sequential vs alternating chemotherapy and radiotherapy. J Natl Cancer Inst. 2009 Feb 4;101(3):142-52. doi: 10.1093/jnci/djn460. Epub 2009 Jan 27.
- Lefebvre J, Horiot J, Rolland F, et al.: Phase III study on larynx preservation comparing induction chemotherapy and radiotherapy versus alternating chemoradiotherapy in resectable hypopharynx and larynx cancers. EORTC protocol 24954-22950. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA6016, 303s, 2007.
- Bottomley A, Tridello G, Coens C, Rolland F, Tesselaar ME, Leemans CR, Hupperets P, Licitra L, Vermorken JB, Van Den Weyngaert D, Truc G, Barillot I, Lefebvre JL. An international phase 3 trial in head and neck cancer: quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group. Cancer. 2014 Feb 1;120(3):390-8. doi: 10.1002/cncr.28392. Epub 2013 Oct 25.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료
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
- EORTC-24954
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .