Cancer Institute and Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
NCT Number: NCT02446574
This is a unicentered phase I/II study to explore the dose of paclitaxel and cisplatin with radiation therapy, and to document the adverse events for further clinical trial.
Looking for future studies?
Notify Me18 year–68 year
All sexes
Interventional
Phase 1 / Phase 2
Beijing, Beijing Municipality, 100021, China
Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients with pathologically positive lymph nodes who have been treated with resection alone. The investigators have proved the value of prophylactic radiation therapy after radical esophagectomy for esophageal carcinoma with positive lymph node metastases under the conventional 2-dimensional radiotherapy methods in subset analysis of prospective randomized clinical trial. For patients with positive lymph nodes, 5 year survival after surgery alone was 28.4%, median overall survival was 24 months, recurrence occurred 34.6% in mediastinal lymph nodes,13.3% in supraclavicular lymph nodes,10% in abdominal lymph nodes. Distant metastases occurred in 21% patients. Adjuvant radiotherapy significantly reduced the recurrence in mediastinal lymph nodes(13.4%), supraclavicular lymph nodes (6.1%). However distant metastases rate increased to 30.7%. Chemotherapy may be vital for these patients. Chen reported that the 5 year overall survival rates for the chemoradiotherapy group and radiotherapy group were 47.4% and 38.6% (P=0.03). Based on the investigators' studies, treatment failure occurred in 8% patients because of celiac metastases. Small radiation field by omitting celiac axis lymph node basin may ensure 5-6 cycles of concurrent chemotherapy for lower toxicity.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hemoglobin at least 10 g/dL Hepatic Not specified Renal Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 65 mL/min Calcium no greater than 11 mg/dL Cardiovascular No uncontrolled heart disease No uncontrolled hypertension
Exclusion criteria
starting dose 20mg/m2 qw
Other names: taxel
dose 25mg/m2 qw
Other names: platimum
60Gy/2Gy/30f
Time frame: 3 months
Time frame: 18 months
Time frame: 60 months
Time frame: 36 months
Chinese Academy of Medical Sciences
Other
Phase I /II Study of Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01719926
Adnexal Diseases, Colonic Diseases
Amsterdam, Netherlands
View Trial DetailsNCT00213486
Digestive System Diseases, Digestive System Neoplasms
Rouen, France
View Trial DetailsNCT02359968
Digestive System Diseases, Digestive System Neoplasms
Angers, France
View Trial DetailsNCT06027515
Digestive System Diseases, Digestive System Neoplasms
Boston, Massachusetts, United States
View Trial Details