NCT04138212RecruitingPhase 3
Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)
Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903)
Source: ClinicalTrials.gov · Last updated 9 Aug 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Multimodal treatment combining surgery with chemotherapy and/or radiotherapy is necessary to improve the chances of survival in patients with locally advanced thoracic esophageal cancer. However, there is no consensus about the neoadjuvant treatment for resectable locally advanced esophageal squamous cell carcinoma. The aim of current randomized controlled clinical trail is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiation therapy plus surgery on overall survival for patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 456 patients with locally advanced esophageal squamous cell carcinoma in 3 years. Eligible patients will be randomized into neoadjuvant chemotherapy group (paclitaxel 175mg/m2 plus cisplatin 75mg/m2, q21d, 2 cycles) or neoadjuvant chemoradiation group (41.4Gy, 1.8Gy\*23d plus paclitaxel 50mg/m2 plus carboplatin AUC=2, q1w, 5 cycles). The primary endpoint is 5 year overall survival and the secondary endpoints include 5 year disease-free survival, adverse events, pathologic complete response, postoperative complications, quality of life. The biomarkers predicting the sensitivity of neoadjuvant therapy will be explored.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 456 (estimated)
- First submitted
- 20 Oct 2019
- Start date
- 22 Oct 2019
- Primary completion date
- 21 Dec 2023
- Lead sponsor
- Henan Cancer Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04138212
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 456
- From 22 Oct 2019 to the primary completion date, 21 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent cancer disease in other site
- Need continuous steroid treatment
- Can not achieve R0 resection
Other illness
- Previous cancer treatment history
- Cardiac infarction in 6 months
Other
- Tumor length ≥8cm
- Tumor width ≥5cm
- Psychotic patient
- Gastric tube can not be used for reconstruction after esophagectomy
- Pregnant woman
Who the study is looking for
- cT2-T4aN+M0 or cT3-4aN0M0 (8th TNM staging system) thoracic esophageal squamous cell carcinoma
- No metastatic cervical lymph node
- No anti-cancer treatment
- No contraindication for esophagectomy
- No contraindication for chemotherapy or chemoradiation therapy
- PS score 0-1
- Written consent is obtained
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.