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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Simcere Pharmaceutical Co., Ltd.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01646853
First received: July 9, 2012
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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 Intervention
Esophageal Neoplasms
Radiation: Megavoltage photon beam
Drug: cisplatin-fluorouracil chemotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Simcere Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Objective Tumor Response [ Time Frame: One day after completion of the initial therapeutic dose (50.0Gy) and the total dose of radiotherapy ] [ Designated as safety issue: No ]
    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:
  • adverse events [ Time Frame: Side effect assessment was performed every week for the duration of concurrent radiochemotherapy, an expected average of 5 weeks ] [ Designated as safety issue: Yes ]
    using the National Cancer Institute Common Toxicity Criteria,predominantly observe the presence of radiation esophagitis,radiaion pneumonia and hematological toxicity.


Estimated Enrollment: 500
Study Start Date: August 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646853

Contacts
Contact: Xinchen Sun, M.D.,Ph.D. +86-025-68135700 shuizhuqq@yahoo.cn

Locations
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
Simcere Pharmaceutical Co., Ltd
Investigators
Principal Investigator: Xinchen Sun, M.D.,Ph.D. Jiangsu Province Hospital
  More Information

No publications provided

Responsible Party: Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01646853     History of Changes
Other Study ID Numbers: JSNT0415
Study First Received: July 9, 2012
Last Updated: July 18, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014