Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer

Treatments: Other: Adjuvant chemoradiotherapy; Other: Neoadjuvant chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01463501

ZhejiangCH09

Details and patient eligibility

About

This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.

Full description

Patient Population:

Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1, M0

Scheme:

Patients are randomized to 2 arms:

Arm A:

Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.

Arm B:

Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20cm from the incisors) or gastroesophageal junction are included.
• No distant metastases (M0).
• Patients will be stratified by stage (clinical N0 versus clinical N1).
• Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
• Resectable mediastinal nodes are eligible.
• No prior chemotherapy for this malignancy.
• No prior radiotherapy that would overlap the field(s) treated in this study.
• Patients with other malignancies are eligible only if > 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
• Age > 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.

Exclusion criteria

• Cancers of the cervical esophagus (< 20 cm are excluded).
• Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
• Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
• Patients with biopsy proven metastatic celiac nodes are ineligible.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Neoadjuvant Treatment

Experimental group

Description:

Preoperative chemotherapy/radiotherapy

Treatment:

Other: Neoadjuvant chemoradiotherapy

Adjuvant Treatment

Experimental group

Description:

Postoperative chemotherapy/radiotherapy

Treatment:

Other: Adjuvant chemoradiotherapy