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

Who is this study for? Patients with Esophageal Cancer

What treatments are being studied? Paclitaxel+Platinum+PEG-rhG-CSF

Status: Recruiting

Location: See location...

Intervention Type: Radiation, Drug

Study Type: Interventional

Study Phase: Phase 3

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 16

Maximum Age: 70

Healthy Volunteers: f

View:

• 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.

Locations

Other Locations

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)

RECRUITING

Beijing

Contact Information

Primary

Zefen Xiao, MD

xiaozefen@sina.com

+86-13621018159

Backup

Lei Deng, MD

dengleipumc@163.com

+86-18611766429

Time Frame

Start Date: 2018-11-01

Estimated Completion Date: 2027-10-31

Participants

Target number of participants: 300

Treatments

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.

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.

Related Therapeutic Areas

Esophageal Cancer

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