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

Esophageal Cancer Clinical Trial

Official title:

Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03731442
• Other study ID #: 18-175/1753
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2018
• Est. completion date: October 31, 2027

Study information

• Verified date: December 2018
• Source: Chinese Academy of Medical Sciences
• Contact: Zefen Xiao, MD
• Phone: +86-13621018159
• Email: xiaozefen[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Recurrence

Intervention

Radiation:
• Involved field irradiation
Involved field irradiation; intensity-modulated radiation therapy
• Elective field irradiation
Elective field irradiation; intensity-modulated radiation therapy

Drug:
• Paclitaxel
Paclitaxel 135-150mg/m2, d1, every 3 weeks
• 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;
• PEG-rhG-CSF
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy

Locations

Country	Name	City	State
China	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

Sponsors (7)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Anyang Tumor Hospital, Beijing Cancer Hospital, Fujian Cancer Hospital, Hebei Medical University Fourth Hospital, The First Affiliated Hospital with Nanjing Medical University, Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-, 2-, 3-year overall survival	Overall survival	From treatment initiation to death from any cause or censor, assessed up to 36 months
Secondary	1-, 2-, 3-year local progression-free survival	Local progression-free survival	From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
Secondary	1-, 2-, 3-year progression-free survival	Progression-free survival	From treatment initiation to first documented progression or death or censor, assessed up to 36 months
Secondary	Simultaneously integrated boost radiation therapy completion rate	Radiation therapy completion rate	During chemoradation, assessed up to 60 days
Secondary	Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities	Toxicities of chemoradiation therapy	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