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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01646853
Recruitment Status : Unknown
Verified July 2012 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was:  Not yet recruiting
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
Information provided by (Responsible Party):
Simcere Pharmaceutical Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Radiation: Megavoltage photon beam Drug: cisplatin-fluorouracil chemotherapy Not Applicable

Detailed Description:

Esophageal cancer (EC) continues to be a major health burden worldwide. The 5-year survival rates for esophageal cancer have remained less than 15% over decades, probably because of ineffective therapies and the detection of late-stage cancers. Concurrent chemo-radiotherapy was established as one of the viable options for therapy of patients with localized EC following the results from the landmark trial of the Radiation Therapy Oncology Group (RTOG) 85-01 trial, showing a significant survival advantage of concurrent chemoradiation over radiation alone.

The use of radiochemotherapy with cisplatin and 5-fluorouracil (5-FU) is a well-accepted standard for the definitive treatment of esophageal cancer in China which has also been demonstrated efficacy and good tolerability internationally. The AJCC recommended dose range of radiotherapy for concurrent therapy is 45-50.4Gy. Moreover, (RTOG) 85-01 trial also established 50.4 Gy as the standard dose of radiation to be administered concurrently with chemotherapy. However, the appropriate dose of radiation fit for Chinese remains controversial. Due to insufficient evidence of EBM, radiation therapist in China always prescribe a radiation dosage by their own experience. Dosages (e.g. 60-64Gy) significantly higher than the international standard is commonly used in Chinese EC patients which lead to a greater likelihood of toxicity. Thus Chinese oncologists are urgent to reach a consensus about radiation dosage in the standard treatment of local advanced EC.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Study Start Date : August 2012
Estimated Primary Completion Date : December 2013

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Arm Intervention/treatment
Experimental: Concurrent radiochemotherapy Radiation: Megavoltage photon beam
initial dose:50Gy/2Gy/25f,5days/week escalation dose:4Gy/2Gy/2f
Drug: cisplatin-fluorouracil chemotherapy
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
Other Name: PF chemotherapy

Primary Outcome Measures :
  1. Objective Tumor Response [ Time Frame: One day after completion of the initial therapeutic dose (50.0Gy) and the total dose of radiotherapy ]
    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.

Secondary Outcome Measures :
  1. adverse events [ Time Frame: Side effect assessment was performed every week for the duration of concurrent radiochemotherapy, an expected average of 5 weeks ]
    using the National Cancer Institute Common Toxicity Criteria,predominantly observe the presence of radiation esophagitis,radiaion pneumonia and hematological toxicity.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Biopsy-proven squamous cell carcinoma or adenocarcinoma of thoracic or cervical esophagus or gastroesophageal junction esophagus, including the gastroesophageal junction
  2. Measurable lesion
  3. Age > 18 years
  4. Karnofsky performance score > 70
  5. Life expectancy > 3 months
  6. 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).

Exclusion Criteria:

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01646853

Contact: Xinchen Sun, M.D.,Ph.D. +86-025-68135700

China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
Principal Investigator: Xinchen Sun, M.D.,Ph.D. The First Affiliated Hospital with Nanjing Medical University

Responsible Party: Simcere Pharmaceutical Co., Ltd Identifier: NCT01646853     History of Changes
Other Study ID Numbers: JSNT0415
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs