Radiation Dose Study of Concurrent Chemoradiotherapy With Cisplatin Plus Fluorouracil in Oesophageal Cancer

NCT01646853 | Unknown

• 1 other identifier: JSNT0415
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the optimal radiation dosage used in concurrent chemo-radiotherapy in Chinese population. A dose climbing experiment is carried out with an initiate dose of 50Gy conventionally applied in Western countries.

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Objective Tumor Response

  objective evaluation is made according to the standards of Response Evaluation Criteria in Solid Tumors (RECIST)，defined as complete response(CR),partial response (PR)，stable disease(SD),and progressive disease (PD).Tumor sizes are measured using barium esophagram or CT.

  One day after completion of the initial therapeutic dose (50.0Gy) and the total dose of radiotherapy

Secondary Outcomes (1)

• adverse events

  Side effect assessment was performed every week for the duration of concurrent radiochemotherapy, an expected average of 5 weeks

Study Arms (1)

Concurrent radiochemotherapy

EXPERIMENTAL

Radiation: Megavoltage photon beam; Drug: cisplatin-fluorouracil chemotherapy

Interventions

Megavoltage photon beam RADIATION

initial dose:50Gy/2Gy/25f,5days/week escalation dose:4Gy/2Gy/2f

Concurrent radiochemotherapy

cisplatin-fluorouracil chemotherapy DRUG

cisplatin 75 mg/m2 on day 1 with standard hydration fluorouracil 1000 mg/m2/day1 i.v. by continuous infusion from day 1 to day 4 of each cycle

Also known as: PF chemotherapy

Concurrent radiochemotherapy

Eligibility Criteria

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

You may qualify if:

• Biopsy-proven squamous cell carcinoma or adenocarcinoma of thoracic or cervical esophagus or gastroesophageal junction esophagus, including the gastroesophageal junction
• Measurable lesion
• Age \> 18 years
• Karnofsky performance score \> 70
• Life expectancy \> 3 months
• Adequate bone marrow function (white blood cell \[WBC\] count ≥ 3.5 109/L, neutrophil count ≥ 2.0 109/L, and platelet count ≥ 100 109/L), adequate renal function (creatinine ≤ 2 mg/dL or creatinine clearance ≥ 50 mL/min), and normal liver function (aspartate aminotransferase and alanine aminotransferase less than two times the upper limit of normal, total serum bilirubin ≤ 1.5 mg/dL).

You may not qualify if:

• Prior systemic chemotherapy for EC
• Evidence of distant metastatic disease
• Evidence of uncontrolled medical conditions (e.g.,serious infection,grade 4 hypertension,congestive heart failure)
• A history of concomitant or previous malignancy.
• Physical evidence of peripheral neuropathy or hearing loss

Sponsors & Collaborators

• Simcere Pharmaceutical Co., Ltd: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, 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

• Xinchen Sun, M.D.,Ph.D.

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinchen Sun, M.D.,Ph.D.

CONTACT

+86-025-68135700; shuizhuqq@yahoo.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 20, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

CN (1)