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

Phase 2

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Radiation: enlarge irradiation volume; Radiation: Small volume radiation; Drug: cisplatin; Drug: fluorouracil

• Registration Number: NCT01391572
• Lead Sponsor: Fudan University

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).

Study Timeline

• Status Verified: 2011-03
• Study Start: 2011-04
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-22
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

1. Multiple primary esophageal tumors

2. 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).

3. 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.

4. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.

5. Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	enlarge irradiation volume	After esophagectomy, patients in Arm A will receive Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy
A	cisplatin	After esophagectomy, patients in Arm A will receive Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy
B	Small volume radiation	After esophagectomy, patients in Arm B will receive small field radiation (tumor bed only) + Sequential chemotherapy
A	fluorouracil	After esophagectomy, patients in Arm A will receive Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy
B	cisplatin	After esophagectomy, patients in Arm B will receive small field radiation (tumor bed only) + Sequential chemotherapy
B	fluorouracil	After esophagectomy, patients in Arm B will receive small field radiation (tumor bed only) + Sequential chemotherapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Fudan University Cancer Center; 🇨🇳 Shanghai, Shanghai, China