NCT01051765

Brief Summary

Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. Different with westerns, squamous carcinoma is the main pathological type in china patients. The investigators then initiated a prospective phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.

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
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2009

Typical duration 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

August 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 20, 2010

Status Verified

May 1, 2009

Enrollment Period

2 years

First QC Date

January 19, 2010

Last Update Submit

January 19, 2010

Conditions

Advanced Esophageal Squamous Carcinoma

Outcome Measures

Primary Outcomes (1)

  • overall survival

    2 year

Secondary Outcomes (4)

  • PFS

    1year

  • response rate

    1.5 months

  • adverse events

    2 year

  • polymorphism of UGT1A

    2 year

Study Arms (1)

irinotecan/cisplatin

EXPERIMENTAL

irinotecan 130mg/m2 d1 cisplatin: 30mg/m2, d1,d2 every three weeks

Drug: irinotecan/cisplatin

Interventions

irinotecan/cisplatinDRUG

irinotecan 130mg/m2 d1 cisplatin 30mg/m2, d1,d2 every 3 weeks

irinotecan/cisplatin

Eligibility Criteria

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

You may qualify if:

  • Having signed informed consent
  • Age 18 to 70 years old
  • Histologically confirmed esophageal squamous carcinoma, no prior palliative chemotherapy; recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of irinotecan as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
  • Unresectable recurrent or metastatic disease
  • Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
  • Karnofsky performance status ≥70
  • Life expectancy of ≥3 month
  • No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
  • ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
  • Serum AKP \< 2.5 times ULN (within 7 days before enrollment)
  • Serum creatinine \<1.0 times ULN (within 7 days before enrollment)
  • Bilirubin level \< 1.0 times ULN (within 7 days before enrollment)
  • WBC\>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl(within 7 days before enrollment)
  • No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃；
  • Good compliance

You may not qualify if:

  • previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy
  • Known hypersensitivity to irinotecan
  • Only with Brain or bone metastasis
  • Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
  • No measurable lesions, eg. pleural fluid and ascites
  • Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
  • Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or
  • Pregnancy or lactation period
  • Other previous malignancy within 5 year, except non-melanoma skin cancer
  • Chronic diarrhea
  • Mentally abnormal or disable cognition,including CNS metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhang Xiaodong

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

IrinotecanCisplatin

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Central Study Contacts

zhang xiaodong, MD

CONTACT

86-01-88196175zxd0829@yahoo.com.cn

zhang xiaotian, MD

CONTACT

86-01-88196561zhangxtxx@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 20, 2010

Study Start

August 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2012

Last Updated

January 20, 2010

Record last verified: 2009-05

Locations

CN(1)