- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03082586
Radiation Dose Escalation in Esophageal Cancer
December 19, 2020 updated by: Chen tingfeng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Phase I Trial of Radiation Dose Escalation With Concurrent Weekly Cisplatin and Paclitaxel in Patients With Esophageal Cancer
The aim of this trial is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (DDP & Paclitaxel) in patients with inoperable or medically unresectable esophageal cancer.
Study Overview
Status
Completed
Conditions
Detailed Description
The RTOG 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional remain problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the combined modality approach.
New regimen is urgently needed for improving localregional control and survival.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 210000
- the Ethic Committee of Shanghai General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- Patients with distant metastasis and life expectancy >/= 3 months are eligible.
- Zubrod 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. 1 0. Induction chemotherapy is allowed.
Exclusion Criteria:
- The presence of a fistula.
- Prior radiotherapy that would overlap the radiation fields.
- gastroesophageal junction cancer.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: radiochemotherapy 1
Patients will be treated with radiation therapy 57.2 Gy.
|
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly
Other Names:
|
Experimental: radiochemotherapy 2
Patients will be treated with radiation therapy 64.4 Gy.
|
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
Other Names:
|
Experimental: radiochemotherapy 3
Patients will be treated with radiation therapy 71.6 Gy.
|
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
Other Names:
|
Experimental: radiochemotherapy 4
Patients will be treated with radiation therapy 78.8 Gy.
|
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
Other Names:
|
Experimental: radiochemotherapy 5
Patients will be treated with radiation therapy 86 Gy.
|
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
Other Names:
|
Experimental: radiochemotherapy 6
Patients will be treated with radiation therapy 93.2 Gy.
|
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Dose Limiting Toxicities (DLTs) Occurring in Participants
Time Frame: 15 months
|
The DLTs were defined as grade >/=4 esophatitis, any other grade >/=3 nonhematological toxicity (except nausea and vomiting), or grade >/=4 hematological toxicity lasting more than 7 days, which are possibly, probably, or definitely associated with protocol treatment occurring during and after completion of the HFRT boost treatment.
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15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local Failure
Time Frame: 15 months
|
Local failure will be assessed radiographically using endoscopy with biopsy, CT scan, and a positron emission computed tomography-CT scan.
which was defined as persistence /recurrence of the tumor in the radiation therapy field.
|
15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: tingfeng chen, MD, the ethic committee of shanghai genernal hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.
- Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. doi: 10.1056/NEJM199206113262403.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2016
Primary Completion (Actual)
February 20, 2018
Study Completion (Actual)
February 20, 2018
Study Registration Dates
First Submitted
March 13, 2017
First Submitted That Met QC Criteria
March 13, 2017
First Posted (Actual)
March 17, 2017
Study Record Updates
Last Update Posted (Actual)
December 22, 2020
Last Update Submitted That Met QC Criteria
December 19, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGH201705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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