This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03731442
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
The First Affiliated Hospital with Nanjing Medical University
Tianjin Medical University Cancer Institute and Hospital
Anyang Tumor Hospital
Fujian Cancer Hospital
Peking University Cancer Hospital & Institute
Hebei Medical University Fourth Hospital
Information provided by (Responsible Party):
Zefen Xiao, Chinese Academy of Medical Sciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation. The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Radiation: Involved field irradiation Radiation: Elective field irradiation Drug: Paclitaxel Drug: Platinum Drug: PEG-rhG-CSF Phase 3

Detailed Description:

Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received surgery as their first treatment. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation.

Retrospective data of 218 cases in our hospital indicated patients underwent salvage chemoradiation had significantly improved survival compared with chemotherapy, radiotherapy or best supportive care. For patients with locoregional recurrence, the 1-, 3-year overall survival (OS) rates were statistically higher in patients received salvage chemoradiation than radiotherapy (1-year OS, 70.0% vs. 55.2%, 3-year OS, 41.9% vs. 23.5%, p=0.045). Patients received chemotherapy had 1-year OS of 0%.

Data of 218 cases of our hospital indicated patients received radiation dose > 54Gy had a significantly longer median overall survival time of 21.2 months compared with 11.3 months in patients had <54Gy. The optimal radiation dose should be further investigated.

The recurrence pattern of patients with esophageal cancer after esophagectomy mainly consist of supraclavicular and mediastinal lymph nodes. For patients recurred after radical surgery, prophylactic irradiation to high-risk lymph node regions should be considered. The study use simultaneously integrated boost (SIB) intensity-modulated radiation therapy (IMRT) in this trial, which made different radiation dose to recurrent tumor and high-risk lymph node regions possible.

The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery. Patients were further assigned to receive elective field irradiation (ENI) or involved field irradiation (IFI) according to tumor size, tumor location and time-to-recurrence.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Involved field irradiation
Patients after R0 surgery whose recurrence lesion larger than 5cm in diameter, or largest diameter was less than 5cm but with skip metastasis far from primary tumor or their time-to-recurrence longer than 16 months were assigned to involved field irradiation group. For lesions far from the thoracic stomach, the prescribed dose is 60Gy/2Gy/30f, and for lesions close to the thoracic stomach, the prescribed dose is 59.4-61.2Gy/1.8Gy/33-34f. Chest CT scan is planned at 50Gy. Radiation field should be modified according to the tumor response. Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks. PEG-rhG-CSF (3-6mg) should be given after 48 hours of chemotherapy.If patients received postoperative chemotherapy of paclitaxel and platinum and went through local-regional recurrence within six months, it is allowed to deliver chemotherapy regimens in the second line. Consolidate chemotherapy were adjusted to the patients after radiation therapy.
 Radiation: Involved field irradiation
Involved field irradiation; intensity-modulated radiation therapy

Drug: Paclitaxel
Paclitaxel 135-150mg/m2, d1, every 3 weeks

Drug: Platinum
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;

Drug: PEG-rhG-CSF
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
Experimental: Elective field irradiation
Patients after R1/R2 surgery or R0 surgery with the recurrence lesion whose diameter was less than 5cm without skip metastasis far from primary tumor and time-to-recurrence shorter than 16 months were assigned to elective field irradiation group. For lesions far from the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f with a simultaneously integrated boost up to 59.92-62.16Gy/2.14-2.22Gy/28f. For lesions close to the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f with a sequential boost of 10-12Gy/1.8-2Gy/5-7f. For patients whose planned thoracic stomach V50>50%, the dose should be lowered to 45Gy/1.8Gy/25f. Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks. PEG-rhG-CSF should be given in need. If patients received postoperative chemotherapy of TP and went through local-regional recurrence within 6 months, chemotherapy regimens delivered in the second line. Consolidate chemotherapy were adjusted to the patients after radiation therapy.
 Radiation: Elective field irradiation
Elective field irradiation; intensity-modulated radiation therapy

Drug: Paclitaxel
Paclitaxel 135-150mg/m2, d1, every 3 weeks

Drug: Platinum
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;

Drug: PEG-rhG-CSF
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 1-, 2-, 3-year overall survival [ Time Frame: From treatment initiation to death from any cause or censor, assessed up to 36 months ]
    Overall survival


Secondary Outcome Measures :
  1. 1-, 2-, 3-year local progression-free survival [ Time Frame: From treatment initiation to first documented local progression or death or censor, assessed up to 36 months ]
    Local progression-free survival

  2. 1-, 2-, 3-year progression-free survival [ Time Frame: From treatment initiation to first documented progression or death or censor, assessed up to 36 months ]
    Progression-free survival

  3. Simultaneously integrated boost radiation therapy completion rate [ Time Frame: During chemoradation, assessed up to 60 days ]
    Radiation therapy completion rate

  4. Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities [ Time Frame: Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities ]
    Toxicities of chemoradiation therapy


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locoregional recurrence after radical surgery;
  • Positive resection margin (R1/R2) after surgery;
  • Out-of-field recurrence after adjuvant chemoradiation or radiotherapy;
  • Recurrence after adjuvant chemotherapy;
  • No prior therapy after recurrence;
  • Age 16-70 years;
  • KPS>70;
  • No history of drug allergy;
  • Sufficient liver and kidney functions;
  • White blood cell count > 4.0*10^9/L.

Exclusion Criteria:

  • Age>70 or <16 years;
  • Pregnancy or lactation;
  • History of drug allergy;
  • Declining informed consent;
  • Insufficient liver or kidney functions, or abnormal CBC test;
  • Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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 ClinicalTrials.gov identifier (NCT number): NCT03731442


Contacts
Layout table for location contacts
Contact: Zefen Xiao, MD +86-13621018159 xiaozefen@sina.com
Contact: Lei Deng, MD +86-18611766429 dengleipumc@163.com

Locations
Layout table for location information
China, Beijing
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) Recruiting
Beijing, Beijing, China, 100021
Contact: Zefen Xiao, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
The First Affiliated Hospital with Nanjing Medical University
Tianjin Medical University Cancer Institute and Hospital
Anyang Tumor Hospital
Fujian Cancer Hospital
Peking University Cancer Hospital & Institute
Hebei Medical University Fourth Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Zefen Xiao, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03731442    
Other Study ID Numbers: 18-175/1753
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zefen Xiao, Chinese Academy of Medical Sciences:
Salvage therapy
Recurrence
Chemoradiation
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
 Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action