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

NCT03113214 | Completed

• 1 other identifier: SGH201713
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

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

  1 year

Secondary Outcomes (1)

• Time to Local Failure

  2 years

Study Arms (6)

radiochemotherapy 1

EXPERIMENTAL

Patients will be treated with radiation therapy 57.2 Gy.

Radiation: radiochemotherapy 1

radiochemotherapy 2

EXPERIMENTAL

Patients will be treated with radiation therapy 64.4 Gy.

Radiation: radiochemotherapy 2

radiochemotherapy 3

EXPERIMENTAL

Patients will be treated with radiation therapy 71.6 Gy.

Radiation: radiochemotherapy 3

radiochemotherapy 4

EXPERIMENTAL

Patients will be treated with radiation therapy 78.8 Gy.

Radiation: radiochemotherapy 4

radiochemotherapy 5

EXPERIMENTAL

Patients will be treated with radiation therapy 86 Gy.

Radiation: radiochemotherapy 5

radiochemotherapy 6

EXPERIMENTAL

Patients will be treated with radiation therapy 93.2 Gy.

Radiation: radiochemotherapy 6

Interventions

radiochemotherapy 1 RADIATION

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

Also known as: concurrent radiochemotherapy 1

radiochemotherapy 1

radiochemotherapy 2 RADIATION

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;

Also known as: concurrent radiochemotherapy 2

radiochemotherapy 2

radiochemotherapy 3 RADIATION

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;

Also known as: concurrent chemoradiotherapy regimen 3

radiochemotherapy 3

radiochemotherapy 4 RADIATION

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;

Also known as: concurrent chemoradiotherapy regimen 4

radiochemotherapy 4

radiochemotherapy 5 RADIATION

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;

Also known as: concurrent chemoradiotherapy regimen 5

radiochemotherapy 5

radiochemotherapy 6 RADIATION

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;

Also known as: concurrent chemoradiotherapy regimen 6

radiochemotherapy 6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Genernal Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Tingfeng Chen, MD

  the ethic committee of shanghai genernal hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director, department of radiation

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: February 2, 2017
• Primary Completion: January 10, 2019
• Study Completion: February 2, 2019
• Last Updated: April 5, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)