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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551589
• Other study ID #: CSWOG0001
• Secondary ID: BT-IST-SCCHN-037
• Status: Completed
• Phase: N/A
• First received: March 4, 2012
• Last updated: July 25, 2017
• Start date: March 2012
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: The Second People's Hospital of Sichuan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age = 18 and = 80

2. ECOG performance status 0-2

3. Weight is not less than 90% of it before treatment

4. Histologically proven primary thoracic esophageal squamous cell carcinoma previously untreated stage I-III

5. Chest and abdominal contrast enhanced CT within 2 weeks prior to registration(PET/CT scan is selective)

6. WBC = 4.0X109/L ,Absolute neutrophil count (ANC) = 2.0X109/L

7. Platelets = 100X109/L

8. Hemoglobin = 90g/L(without blood transfusion)

9. AST (SGOT)/ALT (SGPT) = 2.5 x upper limit of normal, Bilirubin = 1.5 x upper limit of normal

10. Creatinine = 1.5 x upper limit of normal

11. 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:

• Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months

• Transmural myocardial infarction within the last 6 months

• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

• 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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Radiation:
• Involved Field Irradiation(IFI)
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.

Drug:
• docetaxel and cisplatin
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.

Radiation:
• 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 4/5/7/16/17were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.

Locations

Country	Name	City	State
China	The Second People's Hospital of Sichuan	Chengdu	Sichuan
China	GuiZhou Cancer Hospital	Guiyang	Guizhou
China	Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University	Kunming	Yunnan
China	Guangxi Tumor Hospital	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Chengya Chou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radiation pneumonitis and radiation esophagitis	radiation pneumonitis and radiation esophagitis,	Acute and late toxicities of lung and esophagus were evaluated according to RTOG criteria with CT scans every 3 months for 1 years
Secondary	3-year Overall survival(OS)	3-year Overall survival(OS)	CT scans performed every 6 months for 3 years
Secondary	3-year Disease-free survival	3-year Disease-free survival	CT scans every 6 months for 3 years
Secondary	Quality of life(QoL)	Quality of life(QoL)	Evaluation of quality of life every week for 3 months
Secondary	Local control rate/ Inside irrational field recurrence rate	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.	2 year