NCT03381651: Neo-DRATEC

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

Completed NA Last updated 18 November 2024

What this trial tests

NA trial testing Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation in Esophageal Carcinoma in 147 participants. Completed in 22 February 2023.

Timeline

22 February 2018

Primary endpoint
22 February 2021

22 February 2023

Quick facts

Lead sponsor	Zhejiang Cancer Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	147
Start date	22 February 2018
Primary completion	22 February 2021
Estimated completion	22 February 2023
Sites	2 locations across China

Drugs / interventions tested

• Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation
• Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation

Conditions studied

• Esophageal Carcinoma — all drugs for Esophageal Carcinoma →
• Neoadjuvant Chemoradiotherapy — all drugs for Neoadjuvant Chemoradiotherapy →
• Surgery — all drugs for Surgery →

Sponsor

Zhejiang Cancer Hospital

Who can join

Adults 18 to 75, any sex, with Esophageal Carcinoma or Neoadjuvant Chemoradiotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy for the treatment of esophageal squamous cell carcinoma: a propensity score-matched study from the National Cancer Center in China.
   Zhang G, Zhang C, Sun N, Xue L, et al · · 2022 · cited 28× · PMID 34013382 · DOI 10.1007/s00432-021-03659-7
2. Clinical evidence for association of neoadjuvant chemotherapy or chemoradiotherapy with efficacy and safety in patients with resectable esophageal carcinoma (NewEC study).
   Zhou HY, Zheng SP, Li AL, Gao QL, et al · · 2020 · cited 18× · PMID 32637899 · DOI 10.1016/j.eclinm.2020.100422
3. Impact of Radiation Dose on Survival for Esophageal Squamous Cell Carcinoma Treated With Neoadjuvant Chemoradiotherapy.
   Yang Y, Xu X, Zhou X, Bao W, et al · · 2020 · cited 16× · PMID 32974158 · DOI 10.3389/fonc.2020.01431
4. Tumor microenvironment biomarkers predicting pathological response to neoadjuvant chemoimmunotherapy in locally advanced esophageal squamous cell carcinoma: post-hoc analysis of a single center, phase 2 study.
   Feng T, Li Q, Zhu R, Yu C, et al · · 2024 · cited 7× · PMID 39209452 · DOI 10.1136/jitc-2024-008942
5. Neoadjuvant Treatment Strategies for Resectable Proximal Gastric, Gastroesophageal Junction and Distal Esophageal Cancer.
   Ahmad MU, Javadi C, Poultsides GA. · · 2022 · cited 6× · PMID 35406527 · DOI 10.3390/cancers14071755
6. Deep learning-based multimodal pathogenomics integration for precision cancer prognosis.
   Feng X, Song G, Zhang Y, Guo L, et al · · 2026 · PMID 41547829 · DOI 10.1186/s12967-026-07682-5