Unique ID issued by UMIN | UMIN000014632 |
---|---|
Receipt number | R000017008 |
Scientific Title | The phase II study of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients |
Date of disclosure of the study information | 2014/07/25 |
Last modified on | 2018/07/27 09:09:50 |
The phase II study of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients
Induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients
The phase II study of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients
Induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients
Japan |
oral squamous cell carcinoma
Oral surgery |
Malignancy
NO
The objective of this study is to evaluate the safety and efficacy of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients.
This study is multi-center open label trial carried out at eight hospitals.
The patients with OSCC (stage II-IV, primary tumor size is more than 3cm) will be enrolled and received chemotherapy for 2 weeks and followed by definitive surgery.
We investigate antitumor effect and adverse effects, and evaluate the usefulness of this chemotherapy as induction manner.
Moreover we evaluate the effect for survival and QOL by function preserving surgery.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
histological effect (histological response rate)
overall survival, disease-free survival, complication after surgery, the rate of avoidance of reconstructive surgery
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Induction chemotherapy
Cetuximab day1(400mg/m2), day 8 (250mg/m2)
S-1 day 1-14 (80mg/m2)
CDDP day 1-5,8-12 (5mg/m2)
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) histologically confirmed SCC
2) measurable and evaluable tumor
3) untreated case with more than large T2 (maximum size >3cm) tumor
4) Performance status 0-1
5) The functions of main organ (bone marrow, heart, lung, liver, kidney) are almost normal.
1) double cancer case
2) severe systemic complications
3) metastasis to CNS
4) ischemic heart disease
5) active gastrointestinal ulcer
6) severe mental disorder
7) women who are fertile or during pregnancy
8) past illness of severe drug allergy
9) attending doctor's decision as unsuitable patient for this study
55
1st name | |
Middle name | |
Last name | Mitsuhiro Nakazawa |
Osaka university Graduate school of dentistry
Osaka university dental hospital
2nd dept. of oral & maxillofacial surgery
1-8 Yamadaoka Suita Osaka
06-6879-2941
nakazawa@dent.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Mitsuhiro Nakazawa |
Osaka university dental hospital
2nd dept. of oral & maxillofacial surgery
1-8 Yamadaoka Suita Osaka
06-6879-2941
nakazawa@dent.osaka-u.ac.jp
The workshop of chemotherapy for oral cancer
None
Other
NO
大阪大学歯学部附属病院(大阪府)、市立池田病院(大阪府)、市立東大阪医療センター(大阪府)、りんくう総合医療センター(大阪府)、市立伊丹病院(兵庫県)、明和病院(兵庫県)
2014 | Year | 07 | Month | 25 | Day |
Partially published
Completed
2014 | Year | 07 | Month | 17 | Day |
2014 | Year | 08 | Month | 01 | Day |
2019 | Year | 08 | Month | 31 | Day |
2019 | Year | 08 | Month | 31 | Day |
2019 | Year | 08 | Month | 31 | Day |
2019 | Year | 11 | Month | 30 | Day |
2014 | Year | 07 | Month | 24 | Day |
2018 | Year | 07 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017008