Neoplasms

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Digestive System Diseases

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Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

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Fluorouracil

Cisplatin

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Immunologic Factors

After esophagectomy, patients in Arm A will receive Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy

After esophagectomy, patients in Arm B will receive small field radiation (tumor bed only) + Sequential chemotherapy

In Arm A, postsurgical radiation target volume includes tumor bed and elective nodes area

enlarge irradiation volume

In Arm B, postsurgical radiation target volume includes tumor bed only

Small volume radiation

cisplatin

fluorouracil

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

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

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

A randomized phase II trial to estimate the optimal radiation volume of postsurgical radiation for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma (T3-4, any N, M0).

Patient Population:

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

T3-4, any N, M0.

Scheme:

After esophagectomy, patients are firstly stratified by 2 factors: (1)number of lymph node metastasis (\<3 or \>=3) and (2)tumor resection status (R1 resection or R2 resection).

Note: Pathological R0 resection status is required for this study. So here R1 and R2 resection are not actually pathological status of resection, only clinical judgement by physician based on the chest-CT before esophagectomy.

Then patients are randomized to 2 arms:

Arm A:

Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy (4 cycles).

Arm B:

Small field radiation (tumor bed only) + Sequential chemotherapy (4 cycles).

A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer

A Randomized Phase II Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Locoregionally Advanced Thoracic Esophageal Squamous Cell Carcinoma

To evaluate if the survival outcome of postsurgical radiation with a small target volume involved tumor bed only is not worse than a large volume (tumor bed and elective nodes) for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma.

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

To evaluate the rationality of radiation target volumes by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer	NCT01391572	Esophageal Squa...	enlarge irradia... Small volume ra... cisplatin fluorouracil	18 Years - 70 Years	Fudan University
A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer	NCT01391572	Esophageal Squa...	enlarge irradia... Small volume ra... cisplatin fluorouracil	18 Years - 70 Years	Fudan University
A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer	NCT01391572	Esophageal Squa...	enlarge irradia... Small volume ra... cisplatin fluorouracil	18 Years - 70 Years	Fudan University
A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer	NCT01391572	Esophageal Squa...	enlarge irradia... Small volume ra... cisplatin fluorouracil	18 Years - 70 Years	Fudan University

Spots Global Cancer Trial Database for enlarge irradiation volume