![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | |
Unique ID issued by UMIN | C000000244 |
Receipt No. | R000000307 |
Scientific Title | Phase II study of salvage photodynamic therapy for local failure after definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma |
Date of disclosure of the study information | 2005/09/22 |
Last modified on | 2005/09/21 |
Basic information | ||
Public title | Phase II study of salvage photodynamic therapy for local failure after definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma | |
Acronym | Phase II study of salvage PDT for esophageal carcinoma | |
Scientific Title | Phase II study of salvage photodynamic therapy for local failure after definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma | |
Scientific Title:Acronym | Phase II study of salvage PDT for esophageal carcinoma | |
Region |
|
Condition | ||
Condition | esophageal squamous cell carcinoma | |
Classification by specialty |
|
|
Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy and safety of salvage photodynamic therapy for local failure after definitive chemoradiotherapy for esophageal squamous cell carcinoma |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Complete response rate of primary site |
Key secondary outcomes | Occurence rate of adverse event
Progression free survival Overall survival |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||||
No. of arms | 1 | |||
Purpose of intervention | Treatment | |||
Type of intervention |
|
|||
Interventions/Control_1 | Photodynamic therapy | |||
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1) Patients with esophageal squamous cell carcinoma who were treated with defenitive chemoradiotherapy
2) Patients` refusal of salvage surgery 3) assessed cancerous lesion limited within the submucosal layer by EUS 4) histolical confirmation of squamous cell carcinoma from the lesion 5) Performance status(ECOG): 0, 1, 2 6) Written informed consent 7) adequate organ function, defined as; WBC; 3000-12000/mm3, platelet count; >100000/mm3, serum creatinine level <1.5mg/dl, serum bilirubin level<2.0mg/dl, serum transaminase<100IU/l |
|||
Key exclusion criteria | 1) No other active malignancy
2) No other severe medical conditions 3) Patients who are suffered systemic infection 4) Patients who cannot keep shading 5) Lesions were judged within mucosal laiyer, and can be treated with EMR 6) Lesions were assessed as T4 before CRT. 7) clinically defined distant or lymph node metastasis by computed tomography and endoscopic ultrasound (EUS) before PDT 8) Patients with porphyria 9) Lesions were not completely evaluated because of stenosis after CRT |
|||
Target sample size | 37 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | National Cancer Center Hospital East | ||||||
Division name | Division of digestive endoscopy and GI oncology | ||||||
Zip code | |||||||
Address | 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan | ||||||
TEL | 04-7133-1111 | ||||||
Public contact | |||||||
Name of contact person |
|
||||||
Organization | National Cancer Center Hospital East | ||||||
Division name | Division of digestive endoscopy and GI oncology | ||||||
Zip code | |||||||
Address | |||||||
TEL | |||||||
Homepage URL | |||||||
toyano@east.ncc.go.jp |
Sponsor | |
Institute | National Cancer Center Hospital East |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Health, Labour and Welfare |
Organization | |
Division | |
Category of Funding Organization | |
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 |
|
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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 | |||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000307 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |