Head and Neck Cancer Clinical Trial
Official title:
Phase III Study of Hyperfractionated Radiation Therapy With or Without Simultaneaous Application of CIS-Platinum in Patients With Moderately Advanced to Advanced Cancers of the Head and Neck
Verified date | May 2019 |
Source | Swiss Group for Clinical Cancer Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. It is not yet known if radiation therapy plus chemotherapy is more effective than
radiation therapy alone in treating patients with advanced head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus
cisplatin with radiation therapy alone in treating patients with advanced head and neck
cancer.
Status | Completed |
Enrollment | 224 |
Est. completion date | July 2000 |
Est. primary completion date | March 1999 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
DISEASE CHARACTERISTICS: Histologically documented squamous cell cancer of the head and
neck in the following sites: Hypopharynx Larynx Oral cavity Oropharynx Stage III/IV disease
No distant metastases by the following: Chest x-ray (all patients) Liver ultrasound or CT
and bone scintigraphy (all hypopharyngeal cancers, those with involved lower neck nodes,
and as clinically indicated) Multiple sites of disease eligible provided radiotherapy
treatment volume remains acceptable PATIENT CHARACTERISTICS: Age: 20 to 75 Performance status: WHO 0-2 Hematopoietic: WBC greater than 3,000 Platelets greater than 100,000 Hepatic: Not specified Renal: Creatinine clearance at least 60 ml/min No renal disease or impairment of renal function Cardiovascular: No coronary heart disease No cardiac failure No history of pulmonary embolism within 2 years Other: No clinical hearing impairment No peripheral neuropathy with concomitant handicap No severe diabetes mellitus with serious vasculopathy or neuropathy No second cancer except: Nonmelanomatous skin or lip cancer In situ carcinoma of the cervix Blood/body fluid analyses to determine eligibility completed within 14 days prior to registration PRIOR CONCURRENT THERAPY: No prior treatment for head and neck cancer Excisional biopsy for diagnosis allowed |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universitaetsspital | Zurich |
Lead Sponsor | Collaborator |
---|---|
Swiss Group for Clinical Cancer Research |
Switzerland,
Ghadjar P, Hayoz S, Zimmermann F, Bodis S, Kaul D, Badakhshi H, Bernier J, Studer G, Plasswilm L, Budach V, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Impact of weight loss on survival after chemoradiation for locally advanced head and — View Citation
Ghadjar P, Pöttgen C, Joos D, Hayoz S, Baumann M, Bodis S, Budach W, Studer G, Stromberger C, Zimmermann F, Kaul D, Plasswilm L, Olze H, Bernier J, Wust P, Aebersold DM, Budach V. Haemoglobin and creatinine values as prognostic factors for outcome of conc — View Citation
Ghadjar P, Simcock M, Studer G, Allal AS, Ozsahin M, Bernier J, Töpfer M, Zimmermann F, Betz M, Glanzmann C, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Concomitant cisplatin and hyperfractionated radiotherapy in locally advanced head a — View Citation
Ghadjar P, Simcock M, Zimmermann F, Betz M, Bodis S, Bernier J, Studer G, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Predictors of severe late radiotherapy-related toxicity after hyperfractionated radiotherapy with or without concomita — View Citation
Ghadjar P, Sun H, Zimmermann F, Bodis S, Bernier J, Studer G, Aebersold DM; Swiss Group for Clinical Cancer Research (SAKK). Physical examination during chemoradiation predicts outcome of locally advanced head and neck cancer. Secondary results of a rando — View Citation
Huguenin P, Beer KT, Allal A, Rufibach K, Friedli C, Davis JB, Pestalozzi B, Schmid S, Thöni A, Ozsahin M, Bernier J, Töpfer M, Kann R, Meier UR, Thum P, Bieri S, Notter M, Lombriser N, Glanzmann C. Concomitant cisplatin significantly improves locoregiona — View Citation
Taussky D, Rufibach K, Huguenin P, Allal AS. Risk factors for developing a second upper aerodigestive cancer after radiotherapy with or without chemotherapy in patients with head-and-neck cancers: an exploratory outcomes analysis. Int J Radiat Oncol Biol — View Citation
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