Neoplasms

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Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

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Gastrointestinal Neoplasms

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Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Vinorelbine

Cisplatin

Neo-adjuvant Chemoradiotherapy followed by Surgery

1. Radiotherapy combined with concomitant chemotherapy:

   Radiotherapy Program:External radiation with a total dose of 40.0Gy is given in 20 fractions of 2.0Gy,5 fractions a week.

   neo-chemotherapy program: Vinorelbine 25mg/m2, IV (in the vein) on day 1 and day 8 of each 21 day cycle. Cisplatin 75mg/m2,IV DRIP on day 1 of each 21 day cycle;or Cisplatin 25mg/m2,IV DRIP on day 1 to day 4 of each 21 day cycle.

   Number of cycles:two
2. surgery:Mckeown Modification Surgery and total two-field lymphadenectomy

surgery

Jian-hua Fu, Professor

The primary objective is to compare neo-adjuvant chemoradiotherapy followed by surgery versus surgery, in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.

Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 480,000 new cases and 400,000 deaths occurred annually worldwide. In China, every year, no matter new cases or deaths account for more than half of the world. Besides, over 90% of Chinese patients have esophageal squamous cell carcinoma (ESCC).

Surgery is the main treatment of this disease, but the prognosis of patients with locally advanced esophageal cancer is rather poor. As a result of surgery alone, the 5-year survival rate of about 25% has not changed significantly in several decades.

Preoperative chemoradiotherapy followed by surgery seems to hopefully improve the survival of EC. Nevertheless, the results of different studies were inconsistent. Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increased the overall survival of patients with EC compared with surgery alone. It should be noticed that only 84 cases(23%) of ESCC were enrolled in this trial with potential minimal follow-up of 2 years, which may be not perfect to evaluate the effect of this combined therapy for this tumor type.

Up till now, vinorelbine has no indications for esophageal cancer, although, some studied have reported its effect and feasibility to the therapy of EC. Vinorelbine has similar mechanism with paclitaxel and docetaxel, which are recommended for the chemotherapy of EC by NCCN. They are all classified as antimicrotubule agents, which cause mitotic arrest and eventual cell death through inhibition of microtubule dynamics. In comparison with the taxanes, vinorelbine has obvious advantage of few cardiac toxicity. This should be beneficial to prevent cardiac side effects of chemoradiotherapy, especially for the middle or lower thoracic EC, which account for over 70% of thoracic EC in China. For this group of patients, radiotherapy can hardly avoid cardiac toxicity.

Based on our preliminary study, we have demonstrated the validity and safety of vinorelbine and cisplatin-based neoadjuvant chemoradiotherapy.

We are to carry out a phased III clinical trial to investigate the effect of this multidisciplinary therapy for the overall survival of patients with locally advanced ESCC.

Phase III Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer

A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery Versus Surgery for Locally Advanced Squamous Cell Esophageal Carcinoma

Evaluate the toxicities of neo-adjuvant chemoradiotherapy,according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0).

Removal rate， Time of operation， Quantity of bleeding， Thoracic Drainage， Days of Hospitalization， Rate of Operative Complication， Mortality of perioperation，

Criteria:Response Evaluation Criteria in Solid Tumors，RECIST

Affiliated Cancer Hospital of Shantou University Medical College

Shanghai Chest Hospital

Fudan University

Zhejiang Cancer Hospital

Taizhou Hospital

The Second People's Hospital of Sichuan

Tianjin Medical University Cancer Institute and Hospital

Sun Yat-sen University

Professor

Tubulin Modulators

Antimitotic Agents

Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE

only Mckeown MIE using thoracoscopy and laparoscopy

Mckeown MIE

Cheng chu Zhu, professor

min Kong, master

Bao fu Chen, professor

The primary objective is to compare neo-adjuvant chemoradiotherapy followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE, pure radical chemoradiotherapy in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.

Esophageal cancer is one of the most difficult malignancies to cure. Surgical resection remains the primary treatment for localized esophageal cancer. It increases the chances of cure and alleviates the symptoms of dysphagia compared with nonoperative methods. Advances in surgical techniques and equipments have made minimally invasive esophagectomy (MIE) more popular and wider application since 1990s. During the past two decades, MIE has progressively been accepted as an alternative treatment for esophageal cancer around the world. The prognosis has some improvement on account of these significant advances in surgical techniques and perioperative management, But the prognosis of patients with locally advanced esophageal cancer remains rather poor. As a result of surgery alone, the 5-year survival rate of about 25% has not changed significantly in several decades.

Preoperative chemoradiotherapy followed by surgery seems to hopefully improve the survival of EC. Nevertheless, the results of different studies were inconsistent. Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increased the overall survival of patients with EC compared with surgery alone. It should be noticed that only 84 cases(23%) of ESCC were enrolled in this trial with potential minimal follow-up of 2 years, which may be not perfect to evaluate the effect of this combined therapy for this tumor type.

Based on our preliminary study, we have demonstrated the validity and safety of vinorelbine and cisplatin-based neoadjuvant chemoradiotherapy. Then we are to carry out a clinical trial to investigate the effect of this multidisciplinary therapy, by comparing neo-adjuvant chemoradiotherapy followed by Mckeown MIE versus Mckeown MIE, pure radical chemoradiotherapy in terms of the overall survival time (OS) in patients with Stage IIB or III squamous cell esophageal carcinoma.

Study of Neo-adjuvant Chemoradiotherapy Followed by Minimally Invasive Esophagectomy for Squamous Cell Esophageal Cancer

A Single Institution Prospective Randomized Controlled Clinical Trial of Neo-adjuvant Chemoradiotherapy Followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE for Locally Advanced Squamous Cell Esophageal Carcinoma

Evaluate the toxicities of neo-adjuvant chemoradiotherapy,according to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0

The time between the start of surgery until the end of surgery

The total number of lymph nodes obtained including cervix area, mediastinum area , abdominal area

Participants will be followed for the duration of hospital stay after surgery, an expected average of 12 days

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase III Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer	NCT01216527	Squamous Cell E...	Neo-adjuvant Ch... surgery	18 Years - 70 Years	Sun Yat-sen University
Study of Neo-adjuvant Chemoradiotherapy Followed by Minimally Invasive Esophagectomy for Squamous Cell Esophageal Cancer	NCT02188615	Squamous Cell E...	Neo-adjuvant Ch... Cisplatin Mckeown MIE	18 Years - 70 Years	Taizhou Hospital

Spots Global Cancer Trial Database for squamous cell esophageal carcinoma