Different Radiation Dose of Neoadjuvant Chemoradiation for Resectable Thoracic Esophageal Squamous Carcinoma (Neo-DRATEC)

University of Chinese Academy Sciences

Status: Completed

Conditions: Esophageal Carcinoma; Neoadjuvant Chemoradiotherapy; Surgery

Treatments: Radiation: Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation; Radiation: Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT03381651

ZhejiangEC5040

Details and patient eligibility

About

Esophageal cancer is one of the most common cancers worldwide, while more than half new cases and deaths occurred in China. Surgery is the main curative treatment for this disease, the 5-year survival of EC remains poor, since most diseases are diagnosed at advanced stages.

In last decades, several large clinical trials and meta-analyses have demonstrated that neo-adjuvant chemoradiotherapy followed by surgery can significantly increase the overall survival of patients with EC compared with surgery alone, while no effect of nCRT was apparent on postoperative health-related quality of life . However, the optimal radiation dose and surgery timing are still unknown.

The investigators hypothesize that patients who receive higher dose (50.4Gy/28F) of neoadjuvant chemoradiation will have better pathologic response and progress-free survival compared to lower dose (41.4Gy/23F) of chemoradiation followed by surgery.

Enrollment: 147 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age:18-70 years

Histologically verified squamous carcinoma of the thoracic esophagus.

Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.

Tumors should be resectable or potentially resectable and without distant metastasis, as assessed before neoadjuvant CRT, including clinical stage T2-4N0M0 or T1-4N1M0 according to the 6th AJCC system.

Joined the study voluntarily and signed informed consent form

No surgical contraindications

No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥10 g/dL, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≤ 2.5 x ULN, creatinine≤1.5 x ULN

Exclusion criteria

Cervical esophageal cancer (The upper end of the lesion is in the esophagus of the cervical segment).

Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy) proven metastatic supraclavicular or celiac nodes are ineligible.

Invasion of the tracheobronchial tree or aorta

Tracheoesophageal fistula

Concurrent pregnancy or lactation

Severe diabetes mellitus with poor blood glucose control

History of a second malignancy

Patients being unable to undergo esophageal reconstruction with gastric tube, due to prior surgery.

Patients undergoing esophageal reconstruction with jejunum.

Patients have allergy reaction or contraindications to taxanes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 2 patient groups

Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation

Active Comparator group

Description:

Neoadjuvant chemoradiation: RT: 50.4Gy/28F/5.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 6 wks; Surgery: 4-6 weeks after nCRT

Treatment:

Radiation: Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation

Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation

Active Comparator group

Description:

Neoadjuvant chemoradiation: RT: 41.4Gy/23F/4.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 5 wks; Surgery: 4-6 weeks after nCRT

Treatment:

Radiation: Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation