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PET/CT-directed Hyperfractionated Radiation Dose Escalation in Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

radiochemotherapy 1

radiochemotherapy 2

radiochemotherapy 3

radiochemotherapy 4

radiochemotherapy 5

radiochemotherapy 6

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:

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 5.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.

6.Known hypersensitivity to paclitaxel. 7.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. 8.Conditions precluding medical follow-up and protocol compliance

Sites / Locations

Shanghai Genernal Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

radiochemotherapy 1

radiochemotherapy 2

radiochemotherapy 3

radiochemotherapy 4

radiochemotherapy 5

radiochemotherapy 6

Arm Description

Patients will be treated with radiation therapy 57.2 Gy.

Patients will be treated with radiation therapy 64.4 Gy.

Patients will be treated with radiation therapy 71.6 Gy.

Patients will be treated with radiation therapy 78.8 Gy.

Patients will be treated with radiation therapy 86 Gy.

Patients will be treated with radiation therapy 93.2 Gy.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose

Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity

Secondary Outcome Measures

Time to Local Failure

Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan

Full Information

NCT ID

NCT03113214

First Posted

April 10, 2017

Last Updated

April 4, 2019

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03113214

Brief Title

PET/CT-directed Hyperfractionated Radiation Dose Escalation in Esophageal Cancer

Official Title

Phase I Study of PET/CT-directed Hyperfractionated Radiation Dose Escalation With Concurrent Weekly Carboplatin and Paclitaxel in Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

February 2, 2017 (Actual)

Primary Completion Date

January 10, 2019 (Actual)

Study Completion Date

February 2, 2019 (Actual)

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

The goal of this study is to find the maximum tolerable dose of radiation that can be delivered with concurrent chemotherapy (carboplatin & paclitaxel) in patients with esophageal cancer.

Detailed Description

Concurrent chemoradiotherapy is the standard of care for esophageal cancer based on the results of phase III randomised trials. The current standard radiation therapy dose has remained 50 Gy at -2 Gy/fraction for decades.However, locoregional control 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.Investigators hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed tomography (CT) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.

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

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

radiochemotherapy 1

Arm Type

Experimental

Arm Description

Patients will be treated with radiation therapy 57.2 Gy.

Arm Title

radiochemotherapy 2

Arm Type

Experimental

Arm Description

Patients will be treated with radiation therapy 64.4 Gy.

Arm Title

radiochemotherapy 3

Arm Type

Experimental

Arm Description

Patients will be treated with radiation therapy 71.6 Gy.

Arm Title

radiochemotherapy 4

Arm Type

Experimental

Arm Description

Patients will be treated with radiation therapy 78.8 Gy.

Arm Title

radiochemotherapy 5

Arm Type

Experimental

Arm Description

Patients will be treated with radiation therapy 86 Gy.

Arm Title

radiochemotherapy 6

Arm Type

Experimental

Arm Description

Patients will be treated with radiation therapy 93.2 Gy.

Intervention Type

Radiation

Intervention Name(s)

radiochemotherapy 1

Other Intervention Name(s)

concurrent radiochemotherapy 1

Intervention Description

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly

Intervention Type

Radiation

Intervention Name(s)

radiochemotherapy 2

Other Intervention Name(s)

concurrent radiochemotherapy 2

Intervention Description

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;

Intervention Type

Radiation

Intervention Name(s)

radiochemotherapy 3

Other Intervention Name(s)

concurrent chemoradiotherapy regimen 3

Intervention Description

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;

Intervention Type

Radiation

Intervention Name(s)

radiochemotherapy 4

Other Intervention Name(s)

concurrent chemoradiotherapy regimen 4

Intervention Description

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;

Intervention Type

Radiation

Intervention Name(s)

radiochemotherapy 5

Other Intervention Name(s)

concurrent chemoradiotherapy regimen 5

Intervention Description

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;

Intervention Type

Radiation

Intervention Name(s)

radiochemotherapy 6

Other Intervention Name(s)

concurrent chemoradiotherapy regimen 6

Intervention Description

concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose

Description

Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time to Local Failure

Description

Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan

Time Frame

2 years

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: 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 5.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. 6.Known hypersensitivity to paclitaxel. 7.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. 8.Conditions precluding medical follow-up and protocol compliance

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tingfeng Chen, MD

Organizational Affiliation

the ethic committee of shanghai genernal hospital

Official's Role

Study Director

Facility Information:

Facility Name

Shanghai Genernal Hospital

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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PET/CT-directed Hyperfractionated Radiation Dose Escalation in Esophageal Cancer

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