Radiation Dose Escalation in Esophageal Cancer

Not Applicable

Completed

Interventions: Radiation: radiochemotherapy 1
Radiation: radiochemotherapy 3
Radiation: radiochemotherapy 6
Radiation: radiochemotherapy 2
Radiation: radiochemotherapy 4
Radiation: radiochemotherapy 5

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

Brief Summary: The aim of this trial is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (DDP \& Paclitaxel) in patients with inoperable or medically unresectable esophageal cancer.

Detailed Description: The RTOG 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional 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.

Recruitment & Eligibility

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.
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.

Exclusion Criteria

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 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

Arm && Interventions

Group	Intervention	Description
radiochemotherapy 1	radiochemotherapy 1	Patients will be treated with radiation therapy 57.2 Gy.
radiochemotherapy 3	radiochemotherapy 3	Patients will be treated with radiation therapy 71.6 Gy.
radiochemotherapy 6	radiochemotherapy 6	Patients will be treated with radiation therapy 93.2 Gy.
radiochemotherapy 2	radiochemotherapy 2	Patients will be treated with radiation therapy 64.4 Gy.
radiochemotherapy 4	radiochemotherapy 4	Patients will be treated with radiation therapy 78.8 Gy.
radiochemotherapy 5	radiochemotherapy 5	Patients will be treated with radiation therapy 86 Gy.

Primary Outcome Measures

Name	Time	Method
Number of Dose Limiting Toxicities (DLTs) Occurring in Participants	15 months	The DLTs were defined as grade \>/=4 esophatitis, any other grade \>/=3 nonhematological toxicity (except nausea and vomiting), or grade \>/=4 hematological toxicity lasting more than 7 days, which are possibly, probably, or definitely associated with protocol treatment occurring during and after completion of the HFRT boost treatment.

Secondary Outcome Measures

Name	Time	Method
Local Failure	15 months	Local failure will be assessed radiographically using endoscopy with biopsy, CT scan, and a positron emission computed tomography-CT scan. which was defined as persistence /recurrence of the tumor in the radiation therapy field.