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High-dose 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
NCT03535207
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
51
Anticipated Duration (Months)
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 locoregionally advanced esophageal cancer

Condition or Disease Intervention/Treatment Phase
  • Radiation: high dose chemoradiotherapy
 N/A

Detailed Description

The Radiation Therapy Oncology Group (RTOG) 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional failure remains problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the standard dose (50-50.4 Gy) chemoradiotherapy . Our previous phase I radiation dose escalation trial established the maximum tolerated dose of 86 Gy 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 Study of High-dose （86 Gy）Intensity Modulated Radiotherapy and Concurrent Paclitaxel and Cisplatin in Locoregionally Advanced Esophageal Cancer
Actual Study Start Date :
Apr 1, 2018
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: high dose chemoradiotherapy

all eligible patients receive intensity-modulated radiotherapy 50 Gy in 25 fractions over 5 weeks and concurrent paclitaxel and cisplatin once weekly for 5 weeks，followed by hyperfractionated intensity-modulated radiotherapy boost to gross tumor volume concurrent with the same chemotherapy

Radiation: high dose chemoradiotherapy
Radiation therapy: 50 Gy at 2 Gy/Fx/d on weeks 1-5,followed by 36 Gy in 30 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 86 Gy. concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 1.5-2 and paclitaxel 45-50 mg/m2 over the duration (8 weeks) of radiation therapy. Adjuvant chemotherapy after high dose chemoradiation is optional.

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. 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:

  • Histologically confirmed primary squamous cell carcinoma of the esophagus

  • Age 1 8-75.

  • 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.

  • 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 Genernal Hospital Shanghai Shanghai China 210000

Sponsors and Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chen tingfeng, director, department of radiation, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT03535207
Other Study ID Numbers:
  • SGH201802
First Posted:
May 24, 2018
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