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

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT03936179
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
44
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • Radiation: high dose radiation therapy with concurrent chemotherapy
 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
Anticipated Enrollment :
50 participants
Allocation:
N/A
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 :
Aug 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Apr 1, 2022

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 [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 [1 year]

    Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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/ mm3,absolute granulocyte count (AGC) ≥2 × 109 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

Locations

Site City State Country Postal Code
1 Shanghai General Hospital Shanghai China

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chen tingfeng, director,department of radiation therapy, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT03936179
Other Study ID Numbers:
  • SGH201921
First Posted:
May 3, 2019
Last Update Posted:
Mar 18, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Mar 18, 2021