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High-dose 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 chemoradiotherapy

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.
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.
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 Genernal HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

high dose chemoradiotherapy

Arm Description

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

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

toxicities

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

Full Information

NCT ID

NCT03535207

First Posted

May 1, 2018

Last Updated

March 17, 2021

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03535207

Brief Title

High-dose Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer

Official Title

Phase II Study of High-dose （86 Gy）Intensity Modulated Radiotherapy and Concurrent Paclitaxel and Cisplatin in Locoregionally Advanced Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2018 (Actual)

Primary Completion Date

December 30, 2021 (Anticipated)

Study Completion Date

June 30, 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 locoregionally advanced esophageal cancer

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.

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 chemoradiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

high dose chemoradiotherapy

Intervention Description

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.

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

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: 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/ 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. 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

Phone

37798364

Ext

8119

ningcnn@163.com

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

Yong Liu, MD

Phone

37798364

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 Director

Facility Information:

Facility Name

Shanghai Genernal Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

210000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ningning Chen, MD

Phone

37798364

Ext

8119

ningcnn@163.com

First Name & Middle Initial & Last Name & Degree

yong Liu, MD

Phone

37798364

drliuyrt@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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

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

result

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High-dose Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer

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