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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000306 |
Receipt No. | R000000394 |
Scientific Title | Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study |
Date of disclosure of the study information | 2006/03/01 |
Last modified on | 2014/12/26 |
Basic information | ||
Public title | Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study
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Acronym | Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study
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Scientific Title | Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study
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Scientific Title:Acronym | Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study
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Region |
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Condition | ||
Condition | Head and neck squamous cell carcinoma at stage III and IV | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess the efficacy and safety of weekly administration of cisplatin and docetaxel concurrently combined with conventional radiotherapy |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Response rate |
Key secondary outcomes | Survival rate, organ preservation rate, safety |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Concurrent chemoradiotherapy
Radiotherapy: 2Gy/fraction/day, 5fractions/week, total dose of 60-70Gy/30-35fractions for non-nasopharyngeal cancer, or 1.8Gy/fraction/day, 5fractions/week, total dose of 70.2Gy/39fractions for nasopharyngeal cancer Chemotherapy: weekly administration of cisplatin 20mg/m2 and docetaxel 10mg/m2, total of 6 courses Adjuvant chemotherapy of 2 or more than 2 courses of TPF (CDDP+DOC+5-FU) is scheduled for technically unresectable cases. |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) no tumor-specific pretreatment
2) no prior radiation against the same field as currently scheduled 3) estimable or measurable lesion 4) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5) expected survival duration for > 3months after the biginning of the treatment 6) no major impairment of liver, kidney, or bone marrow, fulfilling the condition of AST/ALT <2times the upper limit of normal, BUN <25mg/dl, serum creatinine <1.5mg/dl, creatinine clearance >60ml/min, white blood cell count >4000/mm3, neutrophil count >2000/mm3, and platelet count >100,000/mm3 7) no evidence of active infection or fever >38C 8) written informed consent |
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Key exclusion criteria | 1) interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT
2) major heart/lung disorders, or uncontrolled diabetes mellitus 3) distant metastases or second primary cancer except when there has been no evidence of the disease for more than 24 months without any treatment and when the disease is superficial 4) major pulmonary effusion or ascites 5) neuropathy or edema 6) pregnancy or lactation 7) history of major allergy to medicine 8) long use of steroid |
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Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka University School of Medicine | ||||||
Division name | |||||||
Zip code | |||||||
Address | 2-2 Yamadaoka, Suita, Osaka | ||||||
TEL | 06-6879-5056 | ||||||
hinohara@ent.med.osaka-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Osaka University School of Medicine | ||||||
Division name | Department of Otolaryngology | ||||||
Zip code | |||||||
Address | 2-2 Yamadaoka, Suita, Osaka | ||||||
TEL | 06-6879-5056 | ||||||
Homepage URL | |||||||
hinohara@ent.med.osaka-u.ac.jp |
Sponsor | |
Institute | Department of Otorhinolaryngology and Head and Neck Surgery, Osaka University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Department of Otorhinolaryngology and Head and Neck Surgery, Osaka University School of Medicine |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | CR rate 71%, 2-year overall survival 82%, and 4-year overall survival 68% for technically resectable disease.
CR rate 45%, 2-year overall survival 58%, and 4-year overall survival 44% for technically unresectable disease. |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000394 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |