UMIN-CTR Clinical Trial
| Recruitment status | Terminated |
| Unique ID issued by UMIN | UMIN000003201 |
| Receipt No. | R000003870 |
| Scientific Title | A phase II study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma |
| Date of disclosure of the study information | 2010/02/17 |
| Last modified on | 2019/09/04 (Ver. 11) |
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| Basic information | ||
| Public title | A phase II study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma | |
| Acronym | chemoradiation therapy for advanced or recurrent gastric adenocarcinoma | |
| Scientific Title | A phase II study of palliative chemoradiation therapy with paclitaxel and cisplatin for local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma | |
| Scientific Title:Acronym | chemoradiation therapy for advanced or recurrent gastric adenocarcinoma | |
| Region |
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| Condition | ||
| Condition | gastric cancer | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | Evaluation of efficacy of chemoradiation therapy with paclitaxel and cisplatin for local symptoms
due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | Phase II |
| Assessment | |
| Primary outcomes | Improvement of gastrointestinal obstruction and/or localized pain |
| Key secondary outcomes | Improved duration of gastrointestinal obstruction , survival time, adverse event |
| 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 | chemoradiation therapy
with paclitaxel and cisplatin |
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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) Histologically confirmed gastric cancer
2) Patients who have local symptoms due to an unresectable primary advanced or locally recurrent gastric adenocarcinoma 3) Age between 20 to 80 at registration 4) ECOG PS 0 to 1 5) No or one history of chemotherapy for gastric cancer(adjuvant chemotherapy is excluded) 6) No history of chemotherapy with paclitaxel and cisplatin or chemotherapy including cisplatin(over 240mg/m2) 7) 3 weeks after other chemotherapy 8) No history of radiation therapy for left upper abdomen 9) Over 2 months survival is expected 10) adequate organ function 11) No other active malignancy 12) Written informed consent |
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| Key exclusion criteria | 1) Tumor localization is not detected by neither CT, endoscopy nor upper GI series
2) Serious comorbidities 3) Severe GI obstruction or gastrointestinal bleeding 4) Current inflammation or acute inflammatory disease 5) Allergy to cremophor EL 6) Brain metastasis with symptom 7) Female with present pregnancy or breast-feeding, or contemplating pregnancy. 8) Registered to other clinical trial 9) Patients judged inappropriate for the study by the physicians |
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| Target sample size | 20 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Kanagawa Cancer Center | ||||||
| Division name | Department of Gastrointestinal Surgery | ||||||
| Zip code | 241-8515 | ||||||
| Address | 1-1-2 Nakao, Asahi-Ku, Yokohama 241-0815, Japan | ||||||
| TEL | 0455202222 | ||||||
| takay0218@yahoo.co.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Kanagawa Cancer Center | ||||||
| Division name | Department of Gastrointesitnal Surgery | ||||||
| Zip code | 241-8515 | ||||||
| Address | 1-1-2 Nakao Asahi-Ku, Yokohama 241-0815, Japan | ||||||
| TEL | 0455202222 | ||||||
| Homepage URL | |||||||
| takay0218@yahoo.co.jp | |||||||
| Sponsor | |
| Institute | Study group of multi-modality therapy for gastric cancer |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Kanagawa standard anti-cancer therapy support system (KSATSS) |
| Organization | |
| Division | |
| Category of Funding Organization | Other |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Kanagawa Cancer Center |
| Address | 2-3-2 Nakao Asahi Yokohama Kanagawa Japan |
| Tel | 0455202222 |
| takay0218@yahoo.co.jp | |
| 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 | |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | None |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | None | ||||||
| Number of participants that the trial has enrolled | 5 | ||||||
| Results | This trial was terminated, because sufficient number of patients enrolled. |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Impossible to evaluate |
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| Participant flow | Impossible to evaluate |
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| Adverse events | Impossible to evaluate |
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| Outcome measures | Impossible to evaluate |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Terminated | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry |
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| Date trial data considered complete |
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| 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/icdr_e/ctr_view.cgi?recptno=R000003870 |
