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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 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

the Ethic Committee of Shanghai General 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

Number of Dose Limiting Toxicities (DLTs) Occurring in Participants

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.

Secondary Outcome Measures

Local Failure

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.

Full Information

NCT ID

NCT03082586

First Posted

March 13, 2017

Last Updated

December 19, 2020

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03082586

Brief Title

Radiation Dose Escalation in Esophageal Cancer

Official Title

Phase I Trial of Radiation Dose Escalation With Concurrent Weekly Cisplatin and Paclitaxel in Patients With Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

November 20, 2016 (Actual)

Primary Completion Date

February 20, 2018 (Actual)

Study Completion Date

February 20, 2018 (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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

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)

Masking Description

open label

Allocation

Non-Randomized

Enrollment

31 (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 chemoradiotherapy regimen

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; 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 chemoradiotherapy regimen

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; 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 3

Other Intervention Name(s)

concurrent chemoradiotherapy regimen

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; 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 4

Other Intervention Name(s)

concurrent chemoradiotherapy regimen

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; 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 5

Other Intervention Name(s)

concurrent chemoradiotherapy regimen

Intervention Description

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;

Intervention Type

Radiation

Intervention Name(s)

radiochemotherapy 6

Other Intervention Name(s)

concurrent chemoradiotherapy regimen

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 concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly

Primary Outcome Measure Information:

Title

Number of Dose Limiting Toxicities (DLTs) Occurring in Participants

Description

Time Frame

15 months

Secondary Outcome Measure Information:

Title

Local Failure

Description

Time Frame

15 months

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 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

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

Principal Investigator

Facility Information:

Facility Name

the Ethic Committee of Shanghai General Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

210000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

10235156

Citation

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.

Results Reference

background

PubMed Identifier

1584260

Citation

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.

Results Reference

background

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Radiation Dose Escalation in Esophageal Cancer

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