Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Omission of elective nodal irradiation in N0 hemi-neck of well lateralized H\&N SCCs ( pN0 or by PETCT). Dose de-escalation of elective nodal irradiation in N0 hemi-neck of midline H\&N SCCs ( pN0 or by PETCT).

Elective nodal de-escalation arm

Sara A Elsharkawy

May Ashour

Sara Elsharkawy

Tarek Shouman

This is a non-randomized prospective trial evaluating the non- inferiority of de-escalating the volume and/or dose of elective nodal irradiation in post-operative head and neck squamous cell carcinomas.

This is a non-randomized prospective trial evaluating the non-inferiority of volume and/or dose de-escalation of elective nodal irradiation in post-operative head and neck squamous cell carcinomas with assessment of toxicity profiles.

57 head and neck squamous cell carcinoma cases eligible for post-operative radiotherapy will be recruited and managed according to tumor laterality, nodal status, and laterality of nodal dissection (ipsilateral/ bilateral nodal dissection).

Ipsilateral nodal dissection:

* If ipsilateral N0, bilateral nodal irradiation will be omitted.
* If ipsilateral N positive and tumor was well lateralized, contralateral nodal negativity will be assessed by PETCT. IF PETCT is free, the ipsilateral nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be omitted.
* If ipsilateral N positive and tumor was not well lateralized, ipsilateral nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be de-escalated to 40 Gy dose equivalent.
* Cases with PETCT positive for malignancy will be excluded from the study.

Bilateral nodal dissection:

* If bilateral N0, bilateral nodal irradiation will be omitted.
* If one sided N positive, laterality of the tumor will be assessed:

  * In well lateralized tumors, the positive side nodal regions will be irradiated while the contralateral nodal irradiation will be omitted.
  * In midline/ non lateralized tumor the positive side nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be de-escalated to 40 Gy dose equivalent.
* If bilateral N positive, cases will be excluded from the study.

Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma

National Cancer Institute, Egypt

Digestive System Diseases

Rare Diseases

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

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

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Cisplatin

Antimetabolites

Immunosuppressive Agents

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

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
Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma	NCT05650034	Head and Neck C...	Elective nodal ...	18 Years - 78 Years	National Cancer Institute, Egypt
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
Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma	NCT05650034	Head and Neck C...	Elective nodal ...	18 Years - 78 Years	National Cancer Institute, Egypt
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
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
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 elective nodal irradiation