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NCT Number: NCT03381651

Different Radiation Dose of Neoadjuvant Chemoradiation for Resectable Thoracic Esophageal Squamous Carcinoma

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Radiation

50.4Gy/28F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly

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

Radiation

41.4Gy/23F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly

Primary outcomes

  1. Progression free survival

    Time frame: 2 year

    Time from randomization to tumor progression or any deaths

Secondary outcomes

  1. R0 resection rate in each arm

    Time frame: analysis is completed 4 weeks after surgery

    no cancer cells seen microscopically at the resection margin

  2. Complete pathological response rate

    Time frame: analysis is completed 4 weeks after surgery

    using the Chirieac grading system

  3. Postoperative complications in each study arm

    Time frame: 30 and 90 days after surgery

    According to the NCI CTC3.0

  4. Treatment failure pattern

    Time frame: 2 year

    including local recurrence or distant metastasis or both

  5. Overall survival

    Time frame: 5 year

    by intention to treat and per protocol analyses in each study arm

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

Different Radiation Dose of Neoadjuvant Chemoradiation Followed by Surgery in Treating Patients with Locally Advanced, Resectable Thoracic Esophageal Cancer

Acronym: Neo-DRATEC

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Dec 22, 2017
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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