NCT01444547

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

8.9 years

First QC Date

September 28, 2011

Last Update Submit

May 2, 2014

Conditions

Esophageal Cancer

Keywords

esophageal cancerpaclitaxelcisplatin

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR)

    The primary objective of this study is to determine the response rate of paclitaxel plus cisplatin as first-line therapy in patients with locally advanced, recurrent or metastatic esophageal carcinoma

    5 year

Secondary Outcomes (1)

  • Time to event efficay

    5 year

Study Arms (1)

single-arm Paclitaxel-Cisplatin

EXPERIMENTAL
Drug: paclitaxel and cisplatin

Interventions

paclitaxel and cisplatinDRUG

Paclitaxel 150 mg/m2 will be administered as an intravenous (IV) infusion over 3 hour on Days 1; Cisplatin 50 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day. 14 days as a cycle, up to 8 cycles.

Also known as: Paclitaxel,Beijing Union Pharmaceutical Factory
single-arm Paclitaxel-Cisplatin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven diagnosis of the squamous cell carcinoma or adenocarcinoma of esophagus
  • locally advanced, recurrent or metastatic disease
  • Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale
  • Previous adjuvant or pre-operative chemotherapy without containing paclitaxel or platinum at least 12 months before enrollment
  • Adequate organ function including the following:
  • Bone marrow: absolute neutrophil count (ANC) \>or equal to 1.5 \* 109/L, platelets \>or equal to 100 \*109/L, hemoglobin \> or equal to 10 g/dL.
  • Hepatic: bilirubin \< or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) \< or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin \> or equal to3g/dL.
  • Renal: Calculated creatinine clearance major or equal to 60 ml/min (using the standard Cockcroft-Gault formula).

You may not qualify if:

  • No Prior palliative chemotherapy for advanced disease
  • Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment
  • Known or suspected brain metastasis
  • Second primary malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

Related Publications (2)

  • Lee S, Park YH, Kim KH, Cho EY, Ahn YC, Kim K, Shim YM, Ahn JS, Park K, Im YH. Thymidine synthase, thymidine phosphorylase, and excision repair cross-complementation group 1 expression as predictive markers of capecitabine plus cisplatin chemotherapy as first-line treatment for patients with advanced oesophageal squamous cell carcinoma. Br J Cancer. 2010 Sep 7;103(6):845-51. doi: 10.1038/sj.bjc.6605831. Epub 2010 Aug 10.

    PMID: 20700125RESULT

  • Olaussen KA, Fouret P, Kroemer G. ERCC1-specific immunostaining in non-small-cell lung cancer. N Engl J Med. 2007 Oct 11;357(15):1559-61. doi: 10.1056/NEJMc072007. No abstract available.

    PMID: 17928611RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

TP protocolPaclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Jing Huang, M.D.,Ph.D

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Zhou, M.D

CONTACT

8610-87788800mondaycm@yahoo.com.cn

Xiao Lv, M.D

CONTACT

8610-87788800xiaoxiao81473@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 28, 2011

First Posted

September 30, 2011

Study Start

January 1, 2007

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

CN(1)