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

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

high dose radiation therapy with concurrent chemotherapy

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shanghai General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

high dose radiochemotherapy

Arm Description

A total dose of 86 Gy to residual metabolic disease with concurrent chemotherapy

Outcomes

Primary Outcome Measures

overall survival rate

survival time was measured from the date of study enrollment to the date of death or last follow-up

Secondary Outcome Measures

acute and late toxicities

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

Full Information

NCT ID

NCT03936179

First Posted

May 1, 2019

Last Updated

March 17, 2021

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03936179

Brief Title

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

Official Title

Phase II Trial of High Dose PET/CT-guided Radiation Therapy With Concurrent Weekly Carboplatin and Paclitaxel in Localregionally Advanced Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

August 1, 2021 (Anticipated)

Study Completion Date

April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

high dose radiochemotherapy

Arm Type

Experimental

Arm Description

A total dose of 86 Gy to residual metabolic disease with concurrent chemotherapy

Intervention Type

Radiation

Intervention Name(s)

high dose radiation therapy with concurrent chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

overall survival rate

Description

survival time was measured from the date of study enrollment to the date of death or last follow-up

Time Frame

one year

Secondary Outcome Measure Information:

Title

acute and late toxicities

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ningning Cheng, MD

Phone

377985364

Ext

8119

ningcnn@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yong Liu, MD

Phone

37795364

Ext

8119

drliuyrt@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tingfeng Chen, MD

Organizational Affiliation

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Shanghai General Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ningning Cheng, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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