Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2018
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedFirst Posted
Study publicly available on registry
November 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
ExpectedDecember 12, 2018
December 1, 2018
4 years
October 31, 2018
December 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1-, 2-, 3-year overall survival
Overall survival
From treatment initiation to death from any cause or censor, assessed up to 36 months
Secondary Outcomes (4)
1-, 2-, 3-year local progression-free survival
From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
1-, 2-, 3-year progression-free survival
From treatment initiation to first documented progression or death or censor, assessed up to 36 months
Simultaneously integrated boost radiation therapy completion rate
During chemoradation, assessed up to 60 days
Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
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
Study Arms (2)
Involved field irradiation
EXPERIMENTALPatients 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.
Elective field irradiation
EXPERIMENTALPatients 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.
Interventions
Involved field irradiation; intensity-modulated radiation therapy
Elective field irradiation; intensity-modulated radiation therapy
Paclitaxel 135-150mg/m2, d1, every 3 weeks
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese Academy of Medical Scienceslead
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Tianjin Medical University Cancer Institute and Hospitalcollaborator
- Anyang Tumor Hospitalcollaborator
- Fujian Cancer Hospitalcollaborator
- Peking University Cancer Hospital & Institutecollaborator
- Hebei Medical University Fourth Hospitalcollaborator
Study Sites (1)
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)
Beijing, Beijing Municipality, 100021, China
Related Publications (1)
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.
PMID: 32928136DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 31, 2018
First Posted
November 6, 2018
Study Start
November 1, 2018
Primary Completion
October 31, 2022
Study Completion (Estimated)
October 31, 2027
Last Updated
December 12, 2018
Record last verified: 2018-12