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A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Esophageal Squamous Cell Carcinoma

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Trial Information

A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma


Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a
(according to AJCC2002)

Scheme:

Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging
(N0 or N1), then randomized to 2 arms at 1:1 ratio.

Arm Cisplatin:

Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles.

Arm Paclitaxel:

Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant
chemotherapy for 2 cycles.


Inclusion Criteria:



- Joined the study voluntarily and signed informed consent form;

- Age 18-75

- Both genders

- Esophageal squamous cell carcinoma confirmed by pathology

- Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)

- No radiotherapy, chemotherapy or other treatments prior to enrollment

- PS ECOG 0-2

- Life expectancy of more than 3 months

- Hemoglobin(Hb)≥9 g/dL

- WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L

- platelet count (Pt) ≥100x 109/L

- Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN

- Renal function: creatinine < 1.5 x ULN

- No immuno-deficiency

- Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

- Complete esophageal obstruction

- Deep esophageal ulcer

- Esophageal perforation

- Haematemesis

- After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting
therapy

- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma
in situ, who survived with no evidence disease for over 3 years

- Participation in other interventional clinical trials within 30 days

- Pregnant or breast-feeding women or people during the birth-period who refused to
take contraceptives

- Drug addiction

- Alcoholism or AIDS

- Uncontrolled seizures or psychiatric diseases, loss of control over their own
behavior

- Patient who has metastasis such as lung, liver metastasis

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:

1-yr overall survivals

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Kuai Le Zhao, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

ESO2012-01

NCT ID:

NCT01591135

Start Date:

April 2012

Completion Date:

April 2017

Related Keywords:

  • Esophageal Squamous Cell Carcinoma
  • Esophageal squamous cell carcinoma
  • chemoradiotherapy
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases

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