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Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Radiotherapy

Chemotherapy (5-FU+DDP)

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:

Histopathologically proven diagnosis of esophageal squamous cell carcinoma.
ECOG performance status 0-1.
Able to swallow semifluid diet.
Patients must not have received either radiotherapy or chemotherapy.
Technically unresectable, medically inoperable, or surgery declined by the patient.
SUVmax in the pre-treatment FDG-PET scan > 5 for the primary tumor and the length of the primary tumor ≤10cm.
Normal liver and renal function and adequate bone marrow reservation.
Meet the requirements of the dose limitation to the critical organ: V20≤25%，Dmean≤15Gy for lung; Dmax ≤45Gy for spinal cord，Dmean ≤20Gy for liver.
Written, signed informed consent.

Exclusion Criteria:

Other malignancy histology.
Any evidence of visceral metastases.
Prior radiotherapy to the thorax or systemic therapy for esophageal cancer.
Evidence of deep esophageal ulcer or esophageal perforation.
Weight loss ≥10% within half year or cachexia.
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
History of cardiac disease: congestive heart failure > NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months.
Concurrent uncontrolled medical conditions.
Pregnant or lactating women.
Drug addiction, alcoholism or AIDS.
Uncontrolled seizures or psychiatric, behavioural disorders.

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiotherapy+chemotherapy

Arm Description

Radiotherapy: LEVEL 1: dose given at PTV-G and PTV-C will be 64Gy/32 fractions and 50Gy/25 fractions. LEVEL 2: dose given at PTV-G and PTV-C will be 63Gy/28 fractions and 50.4Gy/28 fractions. LEVEL 3: dose given at PTV-GR (with an integrated boost to the 50% SUVmax area of the primary tumor of the pre-treatment 18FDG-PET/CT scan), PTV-G and PTV-C will be 70Gy/28 fractions, 63Gy/28 fractions and 50.4Gy/28 fractions. LEVEL 4: dose given at PTV-GR (with an integrated boost to the 50% SUVmax area of the primary tumor of the pre-treatment 18FDG-PET/CT scan), PTV-G and PTV-C will be 70Gy/25 fractions, 62.5Gy/25 fractions and 50Gy/25 fractions. Chemotherapy: Concurrent chemotherapy: Cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24 hours daily on Days 1-4 and 29-32. Consolidation chemotherapy: Cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks for 2 cycles.

Outcomes

Primary Outcome Measures

Dose limiting toxicity(DLT)

Secondary Outcome Measures

Overall survival (OS)

Progression-free survival (PFS)

Failure patterns

Late toxicity

Esophageal perforation, esophageal bleeding or late radiation-induced lung or heart injury of grade 3 or above(CTCAE3.0)

Full Information

NCT ID

NCT01843049

First Posted

April 24, 2013

Last Updated

April 26, 2013

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01843049

Brief Title

Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer

Official Title

Dose Escalation Using a Simultaneous Integrated Boost Technique Based on 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer: a Phase I/II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Most local failures after definitive chemoradiation for unresectable esophageal cancer occur in the gross tumor volume (GTV). And the metabolic active areas post-treatment were located in the high FDG uptake areas prior to the radiotherapy. The hypothesis is that selective dose boost to the esophageal GTV could be safely delivered using a simultaneous integrated boost (SIB) technique, and that boosting the high 18F-deoxyglucose (FDG) uptake areas of the esophageal GTV defined prior to treatment may improve local tumor control.

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

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

radiotherapy+chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

Patients will receive from 5 to 6 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy (5-FU+DDP)

Intervention Description

Patients will receive 2 cycles of concurrent chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24h daily on Days 1-4 and 29-32) during radiotherapy period. Consolidation chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks) will be given for 2 cycles one month after the end of radiochemotherapy.

Primary Outcome Measure Information:

Title

Dose limiting toxicity(DLT)

Time Frame

3 months after the finish of the radiotherapy

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Time Frame

3 years

Title

Progression-free survival (PFS)

Time Frame

3 years

Title

Failure patterns

Time Frame

3 years

Title

Late toxicity

Description

Esophageal perforation, esophageal bleeding or late radiation-induced lung or heart injury of grade 3 or above(CTCAE3.0)

Time Frame

3 years

Other Pre-specified Outcome Measures:

Title

Local recurrent rate within the >50% SUVmax region of the primary tumor

Time Frame

3 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: Histopathologically proven diagnosis of esophageal squamous cell carcinoma. ECOG performance status 0-1. Able to swallow semifluid diet. Patients must not have received either radiotherapy or chemotherapy. Technically unresectable, medically inoperable, or surgery declined by the patient. SUVmax in the pre-treatment FDG-PET scan > 5 for the primary tumor and the length of the primary tumor ≤10cm. Normal liver and renal function and adequate bone marrow reservation. Meet the requirements of the dose limitation to the critical organ: V20≤25%，Dmean≤15Gy for lung; Dmax ≤45Gy for spinal cord，Dmean ≤20Gy for liver. Written, signed informed consent. Exclusion Criteria: Other malignancy histology. Any evidence of visceral metastases. Prior radiotherapy to the thorax or systemic therapy for esophageal cancer. Evidence of deep esophageal ulcer or esophageal perforation. Weight loss ≥10% within half year or cachexia. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. History of cardiac disease: congestive heart failure > NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months. Concurrent uncontrolled medical conditions. Pregnant or lactating women. Drug addiction, alcoholism or AIDS. Uncontrolled seizures or psychiatric, behavioural disorders.

Central Contact Person:

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

Wen Yu, MD, PHD

Phone

8621-64175590

Ext

1505

yuzhiwen0827@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaolong Fu, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

25586952

Citation

Yu W, Cai XW, Liu Q, Zhu ZF, Feng W, Zhang Q, Zhang YJ, Yao ZF, Fu XL. Safety of dose escalation by simultaneous integrated boosting radiation dose within the primary tumor guided by (18)FDG-PET/CT for esophageal cancer. Radiother Oncol. 2015 Feb;114(2):195-200. doi: 10.1016/j.radonc.2014.12.007. Epub 2015 Jan 10.

Results Reference

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Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer

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