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This trial studies the efficacy and safty of paclitaxel in combination with cisplatin and 5-fluorouracil(TPF) induction chemotherapy for locally advanced borderline-resectable esophageal squamous cell carcinoma.
Esophageal cancer is one of the most common malignant tumors in China. In Asian countries, esophageal squamous carcinoma is the main pathological type of esophageal carcinoma. Prognosis of esophageal squamous carcinoma is usually poor and surgery is the only radical treatment. However, the optimal therapy pattern for local advanced esophageal carcinoma is still unclear. Part of the patients that clinical staging as T4 and with bulky lymph node metastasis are initially diagnosed as borderline-resectable, which means patients may be able to undergo R0 resection. However, for patients who are diagnosed as borderline-resectable esophageal carcinoma, there are still no sufficient studies implicate that how to improve R0 resection rate by convertion chemotherapy. Cisplatin in combination with 5-FU and docetaxel regimen(DCF) was reported as effective neoadjuvant chemotherapy in treating esophageal squamous carcinoma. However, studies also showed that the DCF regimen caused severe adverse reaction. The mechanism of paclitaxel is similar to docetaxel while with less adverse events than docetaxel. Based on the research situation mentioned above, the investigators decided to conduct a phase II clinical trial to further explore the efficacy and safety of paclitaxel in combination with cisplatin and 5-FU (TPF) induction chemotherapy for locally advanced borderline-resectable esophageal squamous carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel+Cisplatin+5fluorouracil | Experimental | Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel+Cisplatin+5fluorouracil | Drug | Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5. |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | The rate of R0 resection | following resection for up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| pathologic complete response rate | The rate of pathologic complete response following surgery | following resection for up to 36 months |
| OS | the duration from enrollment to the patient's death (all causes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu-hong Li, MD, Ph D | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37919448 | Derived | Wu JD, Wang ZQ, Li QQ, Li ZC, Ren C, Wang DS, Chen JY, Tan Q, Li YH, Yang H. A 3-Year Survival Update from a Phase 2 Study of Paclitaxel Plus Cisplatin and 5-Fuorouracil Induction Chemotherapy for Locally Advanced Borderline-Resectable Esophageal Squamous Cell Carcinoma: The NEOCRTEC-1601 Clinical Trial. Ann Surg Oncol. 2024 Feb;31(2):838-846. doi: 10.1245/s10434-023-14513-0. Epub 2023 Nov 2. | |
| 34319435 |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| for up to 36 months |
| PFS | the duration from enrollment to tumour progression or the patient's death (all causes) (whichever comes first) | for up to 36 months |
| Adverse envents | Incidence of AEs and SAEs during the study. | for up to 12 months |
| Derived |
| Wang Z, Hu M, Hu Y, Li Q, Wu J, Fong WP, Ren C, Wang D, Tan Q, Yang H, Li Y. Paclitaxel plus cisplatin and 5-fluorouracil induction chemotherapy for locally advanced borderline-resectable esophageal squamous cell carcinoma: a phase II clinical trial. Esophagus. 2022 Jan;19(1):120-128. doi: 10.1007/s10388-021-00864-8. Epub 2021 Jul 28. |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |