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

NCT ID: NCT01551589

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-07-31

Brief 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.

Detailed 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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Involved Field Irradiation(IFI)

Involved Field Irradiation(IFI):The clinical target volume of regional lymph node (CTVn) of IFI included the nodal region(s) in which the involved lymph node(s) was/were located.chemothrapy:docetaxel and cisplatin.

Group Type: EXPERIMENTAL

Involved Field Irradiation(IFI)

Intervention Type: RADIATION

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.

docetaxel and cisplatin

Intervention Type: DRUG

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.

Elective Nodal Irradiation (ENI)

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

Group Type: ACTIVE_COMPARATOR

docetaxel and cisplatin

Intervention Type: DRUG

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.

Elective Nodal Irradiation (ENI)

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Other Intervention Names

chemothrrapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengya Chou

OTHER

Sponsor Role: lead

Responsible Party

Chengya Chou

Chairman of Radiotherapy department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

JINYI LANG, M.D.

Role: STUDY_CHAIR

The Second People's Hospital of Sichuan

Locations

Guangxi Tumor Hospital

Nanning, Guangxi, China

GuiZhou Cancer Hospital

Guiyang, Guizhou, China

The Second People's Hospital of Sichuan

Chengdu, Sichuan, China

Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University

Kunming, Yunnan, China

Countries

China

Other Identifiers

BT-IST-SCCHN-037

Identifier Type: OTHER

Identifier Source: secondary_id

CSWOG0001

Identifier Type: -

Identifier Source: org_study_id