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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Esophageal Squamous Cell Carcinoma	Radiation: Involved Field Irradiation(IFI); Drug: docetaxel and cisplatin; Radiation: Elective Nodal Irradiation (ENI)	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Multicenter Prospective Randomized Phase III Trial Comparing Elective to Prophylactic Regional Lymph Node Irradiation for Thoracic Esophageal Cancer
Study Start Date :	March 2012
Actual Primary Completion Date :	July 2017
Actual Study Completion Date :	July 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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.	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.; Other Name: chemothrrapy
Active Comparator: 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.	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.; Other Name: chemothrrapy; 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.

Outcome Measures

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Primary Outcome Measures :

1. radiation pneumonitis and radiation esophagitis [ Time Frame: Acute and late toxicities of lung and esophagus were evaluated according to RTOG criteria with CT scans every 3 months for 1 years ]
   radiation pneumonitis and radiation esophagitis,

Secondary Outcome Measures :

1. 3-year Overall survival(OS) [ Time Frame: CT scans performed every 6 months for 3 years ]
   3-year Overall survival(OS)
2. 3-year Disease-free survival [ Time Frame: CT scans every 6 months for 3 years ]
   3-year Disease-free survival
3. Quality of life(QoL) [ Time Frame: Evaluation of quality of life every week for 3 months ]
   Quality of life(QoL)
4. Local control rate/ Inside irrational field recurrence rate [ Time Frame: 2 year ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

China, Guangxi
Guangxi Tumor Hospital
Nanning, Guangxi, China, 530021
China, Guizhou
GuiZhou Cancer Hospital
Guiyang, Guizhou, China, 550000
China, Sichuan
The Second People's Hospital of Sichuan
Chengdu, Sichuan, China, 610000
China, Yunnan
Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University
Kunming, Yunnan, China, 652100

Sponsors and Collaborators

Chengya Chou

Investigators

Study Chair:	JINYI LANG, M.D.	The Second People's Hospital of Sichuan

More Information

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Responsible Party:	Chengya Chou, Chairman of Radiotherapy department, The Second People's Hospital of Sichuan
ClinicalTrials.gov Identifier:	NCT01551589 History of Changes
Other Study ID Numbers:	CSWOG0001; BT-IST-SCCHN-037 ( Other Identifier: BT-IST-SCCHN-037 )
First Posted:	March 13, 2012
Last Update Posted:	July 26, 2017
Last Verified:	July 2017

Keywords provided by Chengya Chou, The Second People's Hospital of Sichuan:

Esophageal squamous cell carcinoma; Concurrent chemoradiotherapy; Clinical target volume; Safety; Prognosis

Additional relevant MeSH terms:

Carcinoma, Squamous Cell; Esophageal Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms	Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Docetaxel; Cisplatin; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action