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Phase I trial of Nabpaclitaxel combinated radiotherapy for adenocarcinoma of the esophago-gastric junction

Phase I trial of Nabpaclitaxel combinated radiotherapy for adenocarcinoma of the esophago-gastric junction - Phase I trial of Nabpaclitaxel combinated radiotherapy for adenocarcinoma of the esophago-gastric junction

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024088
Enrollment
24
Registered
2016-09-17
Start date
2016-09-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of esophago-gastric junction

Interventions

Protocol of Naqbpacritaxel 120mg/m2~260mg/m2 tri-weekly with radiotherapy 1.8Gy/day (Total 39.6Gy)

Sponsors

Tokyo Women's Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Male and Femae who is More than 20 years Less than 80 years 2)Resectable Adenocarcinoma of esophago-gastric junction Stage2 or Stage3 3)Without metastasis of organs 4)Within 4weeks diagnosis using by GI or CT of Adenocarcinoma of esophago-gastric junction 5)Performance Status(ECOG)is 0or1 6)Without neoadjyuvant therapy 7)It is possible to perform chemo-radiotherapy before operation 8)The cases which meet criteria as follow1)White blood cell:more than 3,000/mm3 2)The number of neutrophil:more than1,500/mm3 3)The number of neutrophil:more than75,000/mm3 4)The amount of hemoglobin:more than9.0g/dl 5)AST or ALT is less than two point five times standard level in our institute 6)Creatinin is less than 1.5mg/dl 7)Neuropathy level is less than Grade 2 8)Total bililubin is less than 1.5mg/dL 9)Infomed consent is obtained

Exclusion criteria

Exclusion criteria: 1)Nobody performe nabpaclitaxcel before 2)Nobody use blood protacts within 2weeks3)Without drug hypersensitivity 4)Neuropathy level is more than Grade2 5)the patients who have another cancer in the time of entry. 6)With severe complication 7)With infection or chronic inflametory disease 8)Patient use the steroid 9)The patient is pregnancy 10)Male whose partner is pregnancy is possibility from now. 11)It is difficult to decide to take part in this trial with Mentaldisease 12)Docters decides patients are unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
Evaluation of maximum tolerated dose and recommended dose

Secondary

MeasureTime frame
Evaluation of Toxicity

Countries

Japan

Contacts

Public ContactKosuke Narumiya

Tokyo Women's Medical University Department of Gastroenterological Surgery

narumiya@ige.twmu.ac.jp03-3353-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026