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

NCT ID: NCT03113214

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-02
• Study Completion Date: 2019-02-02

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.

Detailed 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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radiochemotherapy 1

Patients will be treated with radiation therapy 57.2 Gy.

Group Type: EXPERIMENTAL

radiochemotherapy 1

Intervention Type: 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

radiochemotherapy 2

Patients will be treated with radiation therapy 64.4 Gy.

Group Type: EXPERIMENTAL

radiochemotherapy 2

Intervention Type: 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;

radiochemotherapy 3

Patients will be treated with radiation therapy 71.6 Gy.

Group Type: EXPERIMENTAL

radiochemotherapy 3

Intervention Type: 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;

radiochemotherapy 4

Patients will be treated with radiation therapy 78.8 Gy.

Group Type: EXPERIMENTAL

radiochemotherapy 4

Intervention Type: 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;

radiochemotherapy 5

Patients will be treated with radiation therapy 86 Gy.

Group Type: EXPERIMENTAL

radiochemotherapy 5

Intervention Type: 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;

radiochemotherapy 6

Patients will be treated with radiation therapy 93.2 Gy.

Group Type: EXPERIMENTAL

radiochemotherapy 6

Intervention Type: 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;

Interventions

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

Intervention Type: RADIATION

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;

Intervention Type: RADIATION

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;

Intervention Type: RADIATION

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;

Intervention Type: RADIATION

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;

Intervention Type: RADIATION

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;

Intervention Type: RADIATION

Other Intervention Names

concurrent radiochemotherapy 1; concurrent radiochemotherapy 2; concurrent chemoradiotherapy regimen 3; concurrent chemoradiotherapy regimen 4; concurrent chemoradiotherapy regimen 5; concurrent chemoradiotherapy regimen 6

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chen tingfeng

director, department of radiation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tingfeng Chen, MD

Role: STUDY_DIRECTOR

the ethic committee of shanghai genernal hospital

Locations

Shanghai Genernal Hospital

Shanghai, , China

Countries

China

Other Identifiers

SGH201713

Identifier Type: -

Identifier Source: org_study_id