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Esophageal Squamous Cell Carcinoma

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Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

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Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

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Docetaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Involved Field Irradiation(IFI):The clinical target volume of regional lymph node (CTVn) of IFI included the nodal region(s) in which the involved lymph node(s) was/were located.chemothrapy:docetaxel and cisplatin.

Elective Nodal Irradiation (ENI):The CTVn of ENI included the involved lymph node regions and clinically uninvolved lymph nodal stations according to the location of primary tumor. Lymph node station numbers 1/2/4/5/7, 2/4/5/7 and 4/5/7/16/17 were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.chemothrapy:docetaxel and cisplatin.

Involved Field Irradiation(IFI):only irradiate positive lymph node by CT or PET-CT Radiation: IMRT IMRT is administered with chemotherapy from week 1 to week 8PTV-GTV（primary tumor）：66-70Gy/33\~35F，once a day, 5 times per week PTV-CTV（Clinical target,primary tumor extended 3cm in Axial）：50-56Gy/33\~35f，once a day, 5 times per week PTV-GTVnd（positive node）：66-70Gy/33\~35F，once a day, 5 times per week.

Involved Field Irradiation(IFI)

Drug: docetaxel and cisplatin.Consists of docetaxel 60-80mg/m2 day 1 and cisplatin 25mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.

docetaxel and cisplatin

The CTVn of ENI included the involved lymph node regions and clinically uninvolved lymph nodal stations according to the location of primary tumor. Lymph node station numbers 1/2/4/5/7, 2/4/5/7 and 4/5/7/16/17were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.

Elective Nodal Irradiation (ENI)

JINYI LANG, M.D.

This study examines contrast advantages and disadvantages of elective or prophylactic nodal irradiation in the treatment of esophageal cancer with three-dimensional conformed radiotherapy.

Esophageal lymph node drainage area is rich, according to different sites, easy to metastasis to different regions. For patient underwent concurrent chemoradiotherapy, how reasonable design the clinical target volume of lymph node drainage area has always been controversial, one is to irradiate positive lymph nodes only, the other is to irradiate the easier involved lymph node area according to different sites, in order to contrast advantages and disadvantages of the two kind of target area design，so the study was designed.

Involved Field Irradiation (IFI) Versus Elective Nodal Irradiation (ENI) for Esophageal Cancer

Multicenter Prospective Randomized Phase III Trial Comparing Elective to Prophylactic Regional Lymph Node Irradiation for Thoracic Esophageal Cancer

radiation pneumonitis and radiation esophagitis,

Evaluation after treatment 3 months and two years in the tumor local control and key observation radiation fields inside and outside the tumor recurrence and lymph node metastatic rate. To guide the rational clinical target volume of lymph node of esophageal cancer underwnet concurrent chemoradiotherapy and to Prolong the survival time, improve the quality of life of the patients.

Chengya Chou

Chairman of Radiotherapy department

After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)

After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only

Elective nodal irradiation (ENI)

Adjuvant chemotherapy only

Xu-Wei Cai, M.D., Ph.D.

Xiao-Long Fu, M.D., Ph.D.

Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?

Patient Population:

Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging.

R0 resection; T1-2, N+, M0.

Scheme:

After esophagectomy, patients are firstly stratified by numbers of lymph node metastasis (\<3 or \>=3). Then patients are randomized to 2 arms:

Arm A:

Adjuvant chemotherapy (4 cycles).

Arm B:

Adjuvant chemotherapy (4 cycles) + Elective Nodal Irradiation (bilateral supraclavicular fossa and mediastinum).

Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0

Is Elective Nodal Irradiation (ENI) Necessary For Patients With Thoracic Esophageal Squamous Cell Carcinoma Who Undergo Esophagectomy And With Pathological Stage Of T1-2,N+,M0 -- A Randomized Phase Ⅲ Trial

To evaluate elective nodal irradiation (ENI) is better for the overall survival of patients with thoracic esophageal cancer after esophagectomy who with pathological stage of T1-2, N positive, M0

the incidence rate of adverse events, especially radiation-induced lung toxicity

To evaluate the rationality of ENI after esophagectomy by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences

The First Affiliated Hospital of Soochow University

The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Jiangsu Cancer Institute & Hospital

Affiliated Hospital of Jiangsu University

Zhejiang Cancer Hospital

First Affiliated Hospital of Wenzhou Medical University

Zhejiang University

The First Affiliated Hospital of Anhui Medical University

Anhui Provincial Hospital

Fujian Cancer Hospital

Shanghai Chest Hospital

Shanghai Pulmonary Hospital, Shanghai, China

RenJi Hospital

Fudan University

Xiao-Long Fu / Professor

Cisplatin 35 mg/m2 IV weekly during weeks 1 through 6 of IMRT.

Low risk planning target volume (PTV) of 36 Gy at 2 Gy per fraction daily to bilateral, uninvolved neck nodal regions at risk for harboring microscopic cancer. High risk PTV will receive 70 Gy.

Patrick D. Maguire, M.D.

Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC), though many clinical questions remain. Prior experience has revealed locoregional control (LRC), disease free survival (DFS) and overall survival (OS) at 3 years exceeding 80% after treatment with the use of hyperfractionated intensity modulated radiation therapy (IMRT) and concurrent weekly cisplatin chemotherapy for patients with locally advanced HNSCC. This multi-institutional phase II ZCC00204 trial resulted in an acceptable quality of life (QOL) and toxicity profile. The current trial is an attempt to maintain high LRC, while further minimizing both acute and chronic toxicities, and maximizing QOL.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Involved Field Irradiation (IFI) Versus Elective Nodal Irradiation (ENI) for Esophageal Cancer	NCT01551589	Esophageal Squa...	Involved Field ... docetaxel and c... Elective Nodal ...	18 Years - 80 Years	The Second People's Hospital of Sichuan
Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0	NCT01398449	Esophageal Squa...	Elective nodal ... Adjuvant chemot...	18 Years - 70 Years	Fudan University
Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer	NCT01372111	Head and Neck C...	Cisplatin Elective Nodal ...	18 Years -	Coastal Carolina Radiation Oncology
Involved Field Irradiation (IFI) Versus Elective Nodal Irradiation (ENI) for Esophageal Cancer	NCT01551589	Esophageal Squa...	Involved Field ... docetaxel and c... Elective Nodal ...	18 Years - 80 Years	The Second People's Hospital of Sichuan
Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0	NCT01398449	Esophageal Squa...	Elective nodal ... Adjuvant chemot...	18 Years - 70 Years	Fudan University
Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer	NCT01372111	Head and Neck C...	Cisplatin Elective Nodal ...	18 Years -	Coastal Carolina Radiation Oncology

Spots Global Cancer Trial Database for elective nodal irradiation (eni)