Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2025-04-01

Brief Summary

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A three-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But in China because of its toxic reaction, most of patients stop the halfway. Because low toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely used in clinical.

The purpose of this study is to confirm the difference of Capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 249 patients will be accrued from China within 2 years. The primary endpoints are grade 3-5 AEs and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.

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Detailed Description

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We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into three groups.Experimental group 1 : single drug Capecitabine and concurrent radiotherapy.Experimental group 2: Capecitabine plus oxaliplatin and concurrent radiotherapy. Control group:cisplatin plus 5-fluorouracil and concurrent radiotherapy. To evaluate the adverse events and the overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate.

Conditions

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Stage III Esophageal Squamous Cell Carcinoma Stage II Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Capecitabine-oxaliplatin-radiotherapy

oxaliplatin：65mg/m2，d1，8，22, 29,I.V.or d1, 8, 22, 29, 43, 50, 64, 71,I.V.plus,capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total.

radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Group Type EXPERIMENTAL

Capecitabine(Aibin)

Intervention Type DRUG

capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total

Oxaliplatin(Aiheng)

Intervention Type DRUG

Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.

Radiotherapy

Intervention Type RADIATION

concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

cisplatin with 5-FU and radiotherapy

cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85, 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88.

radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Group Type ACTIVE_COMPARATOR

Radiotherapy

Intervention Type RADIATION

concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

Capecitabine and radiotherapy

capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total, radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Group Type EXPERIMENTAL

Capecitabine(Aibin)

Intervention Type DRUG

capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total

Radiotherapy

Intervention Type RADIATION

concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

Interventions

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Capecitabine(Aibin)

capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total

Intervention Type DRUG

Oxaliplatin(Aiheng)

Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.

Intervention Type DRUG

Radiotherapy

concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

Intervention Type RADIATION

Other Intervention Names

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Aibin Aiheng Radiation Therapy

Eligibility Criteria

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Inclusion Criteria

* age 18-75years old
* Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0
* The patients have not received the surgery or chemo-radiotherapy.
* Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
* ALT、AST≤2.5\*N,Cr≤1.5\*N.
* performance status score 0-2

Exclusion Criteria

* pregnant, lactating women
* Oxaliplatin or fluorouracil Allergy or metabolic disorders
* Radiotherapy contraindications
* History of organ transplantation
* Brain metastasis
* The peripheral nervous system disorders
* Severe infection
* Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
* Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
* Other malignant tumor in recent 5 years.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR