Unique ID issued by UMIN | UMIN000015293 |
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Receipt number | R000017790 |
Scientific Title | Randomized phase II feasibility study of mannitol or furosemide hydration in moderate dose of cisplatin-based chemotherapy with short hydration for advanced non-small cell lung cancer |
Date of disclosure of the study information | 2014/10/01 |
Last modified on | 2021/01/19 13:12:22 |
Randomized phase II feasibility study of mannitol or furosemide hydration in moderate dose of cisplatin-based chemotherapy with short hydration for advanced non-small cell lung cancer
Randomized phase II feasibility study of mannitol or furosemide hydration in cisplatin-based chemotherapy with short hydration for advanced non-small cell lung cancer
Randomized phase II feasibility study of mannitol or furosemide hydration in moderate dose of cisplatin-based chemotherapy with short hydration for advanced non-small cell lung cancer
Randomized phase II feasibility study of mannitol or furosemide hydration in cisplatin-based chemotherapy with short hydration for advanced non-small cell lung cancer
Japan |
advanced non small cell lung cancer
Medicine in general | Pneumology | Adult |
Malignancy
NO
To compare feasibility of mannnitol or furosemide forced diuresis of cisplatin-based chemotherapy with short hydration
Safety
feasibility of mannnitol or furosemide forced diuresis of cisplatin-based chemotherapy with short hydration
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
to evaluate the proportion of renal toxicity in cisplatin-based chemotherapy with short hydration using mannitol
to evaluate the proportion of renal toxicity in cisplatin-based chemotherapy with short hydration using furosemide
20 | years-old | <= |
75 | years-old | >= |
Male and Female
pathologically proven non small cell lung cancer
stage IV or stage III without suitability for curative treatment or postoperative reccurent case
combination chemotherapy using cisplatin plus 3rd generation anticancer drug
at the age of 20 to 75
measurable tumor sites
no prior chemotherapy
no prior systemic anticancer therapy including palliative brain or bone irradiation within 1 week of proposed entry to this trial
ECOG PS of 0 to 1
appropriate organ function
acquisition of written informed
consent
1. pts who will receive CDDP of less than 75 mg/m²/day
2. pts with active co-morbidities including severe conditions of heart diseases, cerebrovascular diseases, gastric ulcers, severe infections, uncontrollable diabetes, psychlogicai diseases, and hearing loss.
3. pts with active interstitial lung diseases.
4. pts with symptomatic brain metastases.
5. pts with active other cancers detected within the past 3 years.
6. pts with massive pleural and cardiac effusion and ascites that need to be immediately treated
7. pts with using oral diuretics
8. pts who can not drink water more than 1L/day.
66
1st name | |
Middle name | |
Last name | Katsuyuki Kiura |
Okayama University Hospital
Department of Respiratory Medicine
2-5-1, Shikatacho, Okayama, Japan
086-223-7151
s_wolfjp@yahoo.co.jp
1st name | |
Middle name | |
Last name | Go Makimoto |
Okayama University Hospital
Department of Repiratory Medicine
2-5-1, Shikatacho, Okayama, Japan
086-223-7151
s_wolfjp@yahoo.co.jp
Okayama University Hospital
none
Self funding
NO
岡山大学病院(岡山県)
2014 | Year | 10 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 01 | Day |
2014 | Year | 10 | Month | 01 | Day |
2014 | Year | 11 | Month | 01 | Day |
2018 | Year | 12 | Month | 31 | Day |
2014 | Year | 09 | Month | 30 | Day |
2021 | Year | 01 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017790
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