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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer

Clinicaltrials.gov identifier NCT03936179

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted August 25, 2020

Study Description

Brief summary:

To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locaregionally esophageal cancer

  • Condition or Disease:Esophageal Cancer
  • Intervention/Treatment: Radiation: high dose radiation therapy with concurrent chemotherapy
  • Phase: N/A
Detailed Description

Standard dose chemoradiotherapy (SCRT) results in poor local control for localregionally advanced esopgageal cancer patients. Most local failures occur in the gross tumor volume.[F-18]-fluorodeoxyglucose (FDG) PET/CT can identify residual metabolic disease (RMD). Hyperfractionated radiotherapy allows for delivering a higher dose without increasing late toxicity. Our previous phase I radiation dose escalation trial demonstrated that 86 Gy could be safely delivered to the RMD with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Phase II Trial of High Dose PET/CT-guided Radiation Therapy With Concurrent Weekly Carboplatin and Paclitaxel in Localregionally Advanced Esophageal Cancer
  • Actual Study Start Date: August 2018
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
Experimental: high dose radiochemotherapy
A total dose of 86 Gy to residual metabolic disease with concurrent chemotherapy
Radiation: high dose radiation therapy with concurrent chemotherapy
standard dose of 50 Gy concurrent weekly with paclitaxel (45 mg/m2) and carboplatin (area under curve 1.5 ), immediately followed by hyperfractionated radiotherapy boost of 36 Gy in 30 fractions of 1.2 Gy to residual metabolic disease as defined by PET/CT
Outcome Measures
  • Primary Outcome Measures: 1. overall survival rate [ Time Frame: one year ]
    survival time was measured from the date of study enrollment to the date of death or last follow-up
  • Secondary Outcome Measures: 1. acute and late toxicities [ Time Frame: 1 year ]
    Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Patients must have FDG-avid and histologically or cytologically proven esophageal
cancer.

- Patients must be deemed unresectable disease or patient is not deemed operable due to
medical reasons.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 No prior radiation
to the thorax that would overlap with the current treatment field.

- Patients with nodal involvement are eligible

- Adequate bone marrow, renal and hepatic functions as assessed by the following:
Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/ mm^3,absolute granulocyte count
(AGC) ≥2 × 10^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of
normal (ULN), Creatinine </ =1 .5 times ULN. - A signed informed consent must be obtained prior to therapy. - No prior radiation to the thorax that would overlap with the current treatment field. Induction chemotherapy is allowed. Exclusion Criteria: - The presence of a fistula. - Prior radiotherapy that would overlap the radiation fields. - gastroesophageal junction cancer or the lower third esophageal cancer invading the gastric wall. - Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements. - Known hypersensitivity to paclitaxel. - Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study. - Acquired Immune Deficiency Syndrome. - Conditions precluding medical follow-up and protocol compliance

Contacts and Locations
Contacts

Contact: Ningning Cheng, MD 377985364 ext 8119 ningcnn@163.com

Contact: Yong Liu, MD 37795364 ext 8119 drliuyrt@163.com

Locations

China
Shanghai General Hospital
Shanghai

Sponsors and Collaborators

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

Study Chair: Tingfeng Chen, MD Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

More Information
  • Responsible Party: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • ClinicalTrials.gov Identifier: NCT03936179 History of Changes
  • Other Study ID Numbers: SGH201921
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: August 25, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Esophageal Neoplasms