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

Primary Purpose

Esophageal Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Involved field irradiation
Elective field irradiation
Paclitaxel
Platinum
PEG-rhG-CSF
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Salvage therapy, Recurrence, Chemoradiation

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Involved field irradiation

Elective field irradiation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

1-, 2-, 3-year overall survival
Overall survival

Secondary Outcome Measures

1-, 2-, 3-year local progression-free survival
Local progression-free survival
1-, 2-, 3-year progression-free survival
Progression-free survival
Simultaneously integrated boost radiation therapy completion rate
Radiation therapy completion rate
Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
Toxicities of chemoradiation therapy

Full Information

First Posted
October 31, 2018
Last Updated
December 10, 2018
Sponsor
Chinese Academy of Medical Sciences
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
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1. Study Identification

Unique Protocol Identification Number
NCT03731442
Brief Title
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients
Official Title
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Salvage therapy, Recurrence, Chemoradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Involved field irradiation
Arm Type
Experimental
Arm Description
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.
Arm Title
Elective field irradiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Involved field irradiation
Intervention Description
Involved field irradiation; intensity-modulated radiation therapy
Intervention Type
Radiation
Intervention Name(s)
Elective field irradiation
Intervention Description
Elective field irradiation; intensity-modulated radiation therapy
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 135-150mg/m2, d1, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Platinum
Intervention Description
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Intervention Description
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
Primary Outcome Measure Information:
Title
1-, 2-, 3-year overall survival
Description
Overall survival
Time Frame
From treatment initiation to death from any cause or censor, assessed up to 36 months
Secondary Outcome Measure Information:
Title
1-, 2-, 3-year local progression-free survival
Description
Local progression-free survival
Time Frame
From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
Title
1-, 2-, 3-year progression-free survival
Description
Progression-free survival
Time Frame
From treatment initiation to first documented progression or death or censor, assessed up to 36 months
Title
Simultaneously integrated boost radiation therapy completion rate
Description
Radiation therapy completion rate
Time Frame
During chemoradation, assessed up to 60 days
Title
Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
Description
Toxicities of chemoradiation therapy
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zefen Xiao, MD
Phone
+86-13621018159
Email
xiaozefen@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Deng, MD
Phone
+86-18611766429
Email
dengleipumc@163.com
Facility Information:
Facility Name
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)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zefen Xiao, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32928136
Citation
Chang X, Deng L, Ni W, Li C, Han W, Gao LR, Wang S, Zhou Z, Chen D, Feng Q, Liang J, Bi N, Lv J, Gao S, Mao Y, Xue Q, Xiao Z. Salvage chemoradiation therapy for recurrence after radical surgery or palliative surgery in esophageal cancer patients: a prospective, multicenter clinical trial protocol. BMC Cancer. 2020 Sep 14;20(1):877. doi: 10.1186/s12885-020-07315-0.
Results Reference
derived

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

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