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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

enlarge irradiation volume

Small volume radiation

cisplatin

fluorouracil

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring thoracic esophageal squamous cell carcinoma, esophagectomy, radiation, tumor bed, elective nodal irradiation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 and ≤70
Performance status 0-1
Weight is not less than 90% of it before operation
Registration within 8 weeks after esophagectomy
Histologically proven primary thoracic esophageal squamous cell carcinoma
R0 resection and number of lymph nodes dissected ≥15 after esophagectomy
Pathological stage of T3-4N0-3M0
Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective)
Without supraclavicular nodes and abdominal regions nodes existed after surgery
Without neo-adjuvant chemotherapy and radiotherapy
WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
Platelets ≥ 100X109/L
Hemoglobin ≥ 90g/L(without blood transfusion)
AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
Creatinine ≤ 1.5 x upper limit of normal
Sign study-specific informed consent prior to study entry

Exclusion Criteria:

Multiple primary esophageal tumors
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
Severe, active comorbidity, defined as follows:
3.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy

Sites / Locations

Fudan University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

Survival

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.

Secondary Outcome Measures

Safety and Tolerability

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

Failure pattern

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.

Full Information

NCT ID

NCT01391572

First Posted

July 8, 2011

Last Updated

July 20, 2011

Sponsor

Fudan University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01391572

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

April 2011 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Fudan University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

Detailed Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

Keywords

thoracic esophageal squamous cell carcinoma, esophagectomy, radiation, tumor bed, elective nodal irradiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

enlarge irradiation volume

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Small volume radiation

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Primary Outcome Measure Information:

Title

Survival

Description

Secondary Outcome Measure Information:

Title

Safety and Tolerability

Description

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

Title

Failure pattern

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 and ≤70 Performance status 0-1 Weight is not less than 90% of it before operation Registration within 8 weeks after esophagectomy Histologically proven primary thoracic esophageal squamous cell carcinoma R0 resection and number of lymph nodes dissected ≥15 after esophagectomy Pathological stage of T3-4N0-3M0 Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective) Without supraclavicular nodes and abdominal regions nodes existed after surgery Without neo-adjuvant chemotherapy and radiotherapy WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L Platelets ≥ 100X109/L Hemoglobin ≥ 90g/L(without blood transfusion) AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal Creatinine ≤ 1.5 x upper limit of normal Sign study-specific informed consent prior to study entry Exclusion Criteria: Multiple primary esophageal tumors Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). Severe, active comorbidity, defined as follows: 3.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception. Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

8621-64175590

Ext

1504

birdhome2000@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Phone

8621-64175590

Ext

1504

birdhome2000@hotmail.com

First Name & Middle Initial & Last Name & Degree

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

12. IPD Sharing Statement

Learn more about this trial

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

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