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NCT Number: NCT03731442

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

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.

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Key information

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Location status: Recruiting

Location contact

Zefen Xiao, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Involved field irradiation

Radiation

Involved field irradiation; intensity-modulated radiation therapy

Elective field irradiation

Radiation

Elective field irradiation; intensity-modulated radiation therapy

paclitaxel

Drug

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

Platinum

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Deng, MD

CONTACT

[email protected]

+86-18611766429

Zefen Xiao, MD

CONTACT

[email protected]

+86-13621018159

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Collaborators

  • Anyang Tumor Hospital
  • Fujian Cancer Hospital
  • Hebei Medical University Fourth Hospital
  • Peking University Cancer Hospital & Institute
  • The First Affiliated Hospital with Nanjing Medical University
  • Tianjin Medical University Cancer Institute and Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2027
First posted
Nov 6, 2018
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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