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Completed

NCT Number: NCT02446574

Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma

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.

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Key information

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • KPS≥70
  • Diagnosis of pathologically positive lymph node thoracic esophageal cancer
  • Complete resection
  • 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

  • Uncontrolled diabetes
  • Interval between surgery and adjuvant therapy more than 3 months
  • 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
  • With Weight loss greater than 10% from baseline
  • With other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • Be pregnant

Treatment and study plan

paclitaxel

Drug

starting dose 20mg/m2 qw

Other names: taxel

Cisplatin

Drug

dose 25mg/m2 qw

Other names: platimum

Radiation

Radiation

60Gy/2Gy/30f

Primary outcomes

  1. Maximum tolerated dose of weekly paclitaxel and cisplatin with concurrent radiation(Phase I endpoint)

    Time frame: 3 months

Secondary outcomes

  1. Toxicities according to the Common Terminology Criteria for Adverse Events version 3.0.

    Time frame: 18 months

  2. Overall Survival survival of weekly paclitaxel and cisplatin with concurrent radiation(Phase II endpoint)

    Time frame: 60 months

  3. Disease-free survival of weekly paclitaxel and cisplatin with concurrent radiation(Phase II endpoint)

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Phase I /II Study of Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
May 18, 2015
Registry last updated
Oct 24, 2017

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.

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