Trial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer
A Phase I/II Trial of Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT for Inoperable,Locally Advanced Esophageal Carcinoma
1 other identifier
interventional
30
1 country
1
Brief Summary
This trial is going to evaluate the efficacy and safety of IMRT / nab-TP chemotherapy for unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy regimen for local advanced and unresectable esophageal cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2014
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 3, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 7, 2017
March 1, 2016
3.3 years
May 3, 2016
February 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progress free survival
3 years
Secondary Outcomes (2)
Overall survival
3 years
CTCAE 4.0 toxicity
6 months
Study Arms (1)
nab-paclitaxel group
EXPERIMENTALWeekly Regimens of paclitaxel Plus Cispaltin Combined With Concurrent IMRT
Interventions
Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT
Eligibility Criteria
You may qualify if:
- inoperable locally advanced histologically confirmed esophageal cancer (T3N0M0-TxNxM1a（AJCC 2002)
- ECOG performance status scale 0-1
- at least 1 measurable target lesions
- white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count ≥ 90 g/dL, serum bilirubin level \< 1.5 of the upper limit of normal (ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L, serum creatinine ≤ 1.5 ULN; and
- normal cardiac function with no severe heart disease.
You may not qualify if:
- history of esophagectomy
- pregnancy or breast feeding
- past history of other cancers except for cured non-melanoma skin cancer or cervical cancer;
- concomitant treatment with other anticancer drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ping Wang, M. D.
Tianjin Medical University Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2016
First Posted
May 5, 2016
Study Start
July 1, 2014
Primary Completion
November 1, 2017
Study Completion
December 1, 2017
Last Updated
February 7, 2017
Record last verified: 2016-03