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Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.


For the esophageal carcinoma in II~III stage, routine dosage of Paclitaxel and platinum
medicine chemotherapy concurrently radical radiotherapy is worthy to be studied. On this
base, we advanced approach the enlarged field radiotherapy and the intervention of Tarceva.
And we approach the therapeutic effect for this method theoretically, which may give a
further reasonable guidance for the clinical therapy.


Inclusion Criteria:



1. Subjects must be confirmed Esophageal Carcinoma pathologically

2. (EUS)I~IVa, without contraindication for radical radiotherapy

3. Subjects haven't been given neither radiotherapy nor chemotherapy before

4. Age 18-70,behavioral status evaluation ECOG scores 0—2 and anticipated survival more
than 3 months

5. In 7 days after being selected, subjects should follow the status: WBC ≥ 4.0 x
10^9/L; ANC ≥ 1.5x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 100 g/L; serum Cr ≤ ULN; serum
bilirubin ≤ ULN; ALT/AST ≤ 2.5ULN

6. Subjects should sign for the informed consent

7. Subjects should perform good compliance

8. Female subjects who have the ability of fertility should take contraception during
the whole course and also 3 months after last dosage.In 7 days before the inclusion,
urine pregnancy tests of subjects should be negative.

Exclusion Criteria:

1. Patients who have uncontrolled infection or severe medical disease

2. Patient who used to appear 4th stage swallowing obstruction or
perforation/symptomatic-perforation after radiotherapy

3. Patients who are/were given any other medicine tests currently/in last 4 weeks

4. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines

5. Women in status of pregnancy

6. Patients with main organ failure

7. Other kinds of abnormal, e.g: mental anomaly, drug abuse, alcohol abuse, and such so
on, with which will not fit for this study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Description:

failure: death from any cause

Outcome Time Frame:

five years after enrollment

Safety Issue:

No

Principal Investigator

Shixiu Wu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

1st affliated hospital of Wen Zhou Medical college

Authority:

China: Ministry of Health

Study ID:

Shixiu - 1

NCT ID:

NCT00686114

Start Date:

May 2008

Completion Date:

March 2013

Related Keywords:

  • Esophageal Cancer
  • Esophageal cancer
  • chemoradiation
  • radiosensitivity
  • EGFR inhibition
  • Esophageal Diseases
  • Esophageal Neoplasms

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