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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113214
• Other study ID #: SGH201713
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: February 2, 2019

Study information

• Verified date: April 2018
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed primary squamous cell carcinoma of the esophagus

2. Age 1 8-75.

3. Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons.

4. Patients with distant metastasis and life expectancy >/= 3 months are eligible.

5. Zubrod performance status 0 to 2

6. No prior radiation to the thorax that would overlap with the current treatment field.

7. Patients with nodal involvement are eligible

8. 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.

9. A signed informed consent must be obtained prior to therapy. 1 0. Induction chemotherapy is allowed

Exclusion Criteria:

1. The presence of a fistula.

2. Prior radiotherapy that would overlap the radiation fields.

3. gastroesophageal junction cancer.

4. 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Radiation:
• radiochemotherapy 1
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
• radiochemotherapy 2
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;
• radiochemotherapy 3
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;
• radiochemotherapy 4
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;
• radiochemotherapy 5
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;
• radiochemotherapy 6
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;

Locations

Country	Name	City	State
China	Shanghai Genernal Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose	Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity	1 year
Secondary	Time to Local Failure	Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan	2 years