Clinical trial NCT03366883: Paclitaxel, Cisplatin,5-FU vs. Radiotherapy Plus Paclitaxel, Cisplatin as Preoperative Therapy for Locally Advanced ESC
Official title: A Phase III Trial Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy With Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Cancer Stage IIB
Esophageal Cancer Stage III
Keywords: preoperative chemotherapy
preoperative chemoradiotherapy
clinical trial
phase III
Esophageal squamous cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Chest Hospital
name: Henan Cancer Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: First Affiliated Hospital of Chongqing Medical University
name: The First Affiliated Hospital of Anhui Medical University
First posted: 2017-12-08
Enrollment: 420
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer. The Preoperative chemoradiotherapy with radical surgery is the standard treatment in China. But, many patients do not receive this treatment for many other reasons. Most of them refused or abandon radiotherapy because of the Intolerable adverse effects of radiotherapy, so we have launched a randomized controlled trial to confirm the non-inferiority of TCF over chemoradiotherapy with TC (TC-RT) as preoperative therapy for locally advanced esophageal squamous cancer in overall survival.


Eligibility criteria: Inclusion Criteria:

* Histologically proven squamous cell carcinoma.
* All lesions are located in the thoracic esophagus.
* Clinical stages IIB and III (excluding T4) based on the 7th UICC-TNM classification.
* 20-75 years old.
* ECOG performance status of 0 or 1.
* Measurable lesions not required.
* No prior therapy against esophageal cancer except for complete resection by endoscopic mucosal resection/endoscopic submucosal dissection with either pM1/M2 disease or pM3 disease without vascular infiltration.
* No prior chemotherapy, radiotherapy or hormonal therapy against any cancers
* Adequate organ function.
* Written informed consent.

Exclusion Criteria:

* Synchronous or metachronous double cancers, except for intramucosal tumor curatively resected by local therapy.
* Active infection requiring systemic therapy
* Positive hepatitis B surface antigen and hepatitis B core antigen or human immunodeficiency virus antibody.(only positive hepatitis B surface antigen should receive anti-virus treatment during study)
* Pregnant or lactating women or women of childbearing potential.
* Patients requiring systemic steroid medication.
* Iodine hypersensitivity.
* Psychiatric disease.
* Hypersensitivity for CremophorEL.
* Poorly controlled diabetes.
* Severe emphysema or pulmonary fibrosis.
* Poorly controlled hypertension.
* Unstable angina within 3 weeks or with a history of myocardial infarction within 6 months.

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
Secondary outcomes:
measure: Disease Free Survival
timeFrame: 3years
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: through study completion, an average of 1 year
measure: Objective Response Rate
timeFrame: up to 24 weeks
measure: Rate of R0 resection
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: TianjinCIH
state: Tianjin
Study officials:
References: