Clinical trial NCT02446574: Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma
Official title: Phase I /II Study of Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Esophageal Neoplasms
Keywords: chemoradiation
dose escalation
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2015-05-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. KPS≥70
2. Diagnosis of pathologically positive lymph node thoracic esophageal cancer
3. Complete resection
4. Adequate organ function:

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:

1. Uncontrolled diabetes
2. Interval between surgery and adjuvant therapy more than 3 months
3. Sign of recurrence on CT scan or ultrasound or PET-CT No palpable supraclavicular lymph nodes or involvement after cytology needle aspiration No lymph nodes greater than 1 cm on CT scan
4. With Weight loss greater than 10% from baseline
5. With other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
6. Be pregnant

Primary outcomes:
measure: Maximum tolerated dose of weekly paclitaxel and cisplatin with concurrent radiation(Phase I endpoint)
timeFrame: 3 months
Secondary outcomes:
measure: Toxicities according to the Common Terminology Criteria for Adverse Events version 3.0.
timeFrame: 18 months
measure: Overall Survival survival of weekly paclitaxel and cisplatin with concurrent radiation(Phase II endpoint)
timeFrame: 60 months
measure: Disease-free survival of weekly paclitaxel and cisplatin with concurrent radiation(Phase II endpoint)
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Science
state: Beijing
Study officials:
affiliation: Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Science
name: Zefen Xiao, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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