Overview

This trial is active, not recruiting.

Condition esophageal squamous cell carcinoma
Treatments docetaxel and cisplatin concurrent chemoradiotherapy, docetaxel and cisplatin
Phase phase 3
Sponsor LANG Jin-yi
Start date March 2012
End date September 2014
Trial size 320 participants
Trial identifier NCT01551589, BT-IST-SCCHN-037, CSWOG0001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
docetaxel and cisplatin concurrent chemoradiotherapy
Drug: Consists of docetaxel 60-80mg/m2 day 1 and cisplatin 25mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles. only irradiate positive lymph node by CT or PET-CT Radiation: IMRT IMRT is administered with chemotherapy from week 1 to week 8 PTV-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
(Active Comparator)
docetaxel and cisplatin
Prophylactic Irradiation easier involved lymph node region according to different primary tumor sites For upper site: CTV include Bilateral supraclavicular/1/2/4/7 region node,middle site:CTV include 2/4/7/8 region node;lower site:CTV include 4/5/7/8/16/17/18 node. CTV need include the region where the positive node is in the same time. Drug: docetaxel and cisplatin The concurrent consists of docetaxel 60-80mg/m2 day 1 and cisplatin 75mg/m2 days 1 to 3,repeat every 3 weeks, for 2 cycles. IMRT IMRT is administered with chemotherapy from week 1 to week 8 PTV-GTV(primary tumor):66-70Gy/33~35F,once a day, 5 times per week PTV-CTV(Clinical target):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

Primary Outcomes

Measure
Local control rate/ Inside irrational field recurrence rate
time frame: 2 year

Secondary Outcomes

Measure
3-year Overall survival(OS)
time frame: CT scans performed every 6 months for 3 years
3-year Disease-free survival
time frame: CT scans every 6 months for 3 years
Quality of life(QoL)
time frame: Evaluation of quality of life every week for 3 months
Safety and Tolerability
time frame: CT scans every 3 months for 1 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Multicenter Prospective Randomized Phase III Trial Comparing Elective to Prophylactic Regional Lymph Node Irradiation for Thoracic Esophageal Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by The Second People's Hospital of Sichuan.