Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer

Wenzhou Medical University

Status and phase: Unknown; Phase 3

Conditions: Esophageal Cancer

Treatments: Drug: Tarceva; Radiation: Radiotherapy; Drug: Paclitaxel; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00686114

Shixiu - 1

Details and patient eligibility

About

This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.

Full description

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.

Enrollment: 344 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 6 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 ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
6. Subjects should sign for the informed consent
7. Subjects should perform good compliance
8. Male and 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 or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
3. Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
4. Patients who multiple foci esophagus
5. Patients who are/were given any other medicine tests currently/in last 4 weeks
6. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
7. Women in status of pregnancy
8. Patients who have complications exist as following:

(1)Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2)A history of myocardial infarction in the past 6 months; (3)There is a need for antibiotic treatment of acute bacterial or fungal infection; (4)Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5)Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6)Uncontrollable seizures, or loss of insight because of mental illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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344 participants in 4 patient groups

A

Experimental group

Description:

Enlarged field + Paclitaxel + Cisplatin + Tarceva

Treatment:

Radiation: Radiotherapy

Drug: Cisplatin

Drug: Paclitaxel

Radiation: Radiotherapy

Drug: Tarceva

B

Experimental group

Description:

Enlarged field + Paclitaxel + Cisplatin

Treatment:

Radiation: Radiotherapy

Drug: Cisplatin

Drug: Paclitaxel

Radiation: Radiotherapy

C

Active Comparator group

Description:

Conventional field + Paclitaxel + Cisplatin + Tarceva

Treatment:

Radiation: Radiotherapy

Drug: Cisplatin

Drug: Paclitaxel

Radiation: Radiotherapy

Drug: Tarceva

D

Active Comparator group

Description:

Conventional field + Paclitaxel + Cisplatin

Treatment:

Radiation: Radiotherapy

Drug: Cisplatin

Drug: Paclitaxel

Radiation: Radiotherapy