Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05937438 |
| Other study ID # |
2023-ky 148 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
July 2023 |
| Source |
Anhui Provincial Hospital |
| Contact |
Dong P Qian, M.D. |
| Phone |
+86-19156007756 |
| Email |
qiandong[@]ustc.edu.cn |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Esophageal squamous cell carcinoma is a common malignancy in China. Although neoadjuvant
chemoradiotherapy followed by esophagectomy remains a standard modality for locally advanced
esophageal squamous cell carcinoma, esophagectomy followed by postoperative radiotherapy is
also prevalent in China. Several retrospective studies demonstrated that postoperative
radiotherapy could improve the prognosis of patients. Nevertheless, there still existed
approximately 11.5% and 17.2% of total patients developing local-regional relapse and
hematological metastasis. The result of Checkmate 577 has shown that postoperative
immunotherapy of nivolumab could improve the disease-free survival (median Disease-free
Survival 29.7 mos vs. 11.0 mos). Therefore, investigators aimed to implement a pilot study to
explore the safety and efficacy of combining postoperative radiotherapy and immunotherapy for
patients with locally advanced esophageal squamous cell carcinoma after esophagectomy.
Description:
Trial Title: Postoperative radiotherapy followed by immunotherapy for locally advanced
esophageal squamous cell carcinoma: A pilot study Trial Objective: To explore the safety and
efficacy of combining postoperative radiotherapy and immunotherapy for patients with locally
advanced esophageal squamous cell carcinoma after esophagectomy.
Trial Design: To enroll 70 patients with locally advanced esophageal squamous cell carcinoma
who would be randomly assigned to experimental arm (esophagectomy followed by postoperative
radiotherapy with immunotherapy) and controlled arm (esophagectomy followed by postoperative
radiotherapy).
Inclusion Criteria: a. 18-75 years old. b. after esophagectomy. c. confirmation of squamous
cell carcinoma by pathological examination. d. pathological staging of pIIb-IVa. e. over 12
lymph nodes dissected during surgery. f. ECOG 0-1. g. signature of inform consent by patients
Exclusion Criteria: a. younger than 18 years old or older than 75 years old. b. without
esophagectomy. c. non-squamous cell carcinoma. d. pathological staging of pI, IIa, IVb. e.
less than 12 lymph nodes dissected during surgery. f. ECOG 2-3 g. no signature of inform
consent.
Esophagectomy: Mckeown or Ivor-Lewis surgery
Staging Examination before Postoperative Radiotherapy: a. ECOG scoring. b. PET-CT
(preferred), or chest contrast CT, abdominal ultrasonography and bone scan. c. PD-L1
expression level of surgical specimen. d. NRS2002 and PG-SGS scoring.
Postoperative radiotherapy Radiotherapy CT simulation: Intravenous contrast is recommended
for CT simulation. Scan thickness should be less than 5 mm. Thermal mask or vacuum bag is
recommended.
Delineation of Clinical Tumor Volume (CTV): CTV should involve relative lymphatic drainage
area for primary lesion at different site. For cervical and upper-thoracic esophageal
squamous cell carcinoma, CTV should involve bilateral supraclavicular (1R), upper and lower
paratracheal (2R and 4R), upper and middle paraesophageal (8U and 8M), subcarinal lymphatic
drainage area. For middle esophageal squamous cell carcinoma, CTV should involve bilateral
supraclavicular (1R), upper and lower paratracheal (2R and 4R), upper, middle and lower
paraesophageal (8U, 8M and 8L), subcarinal lymphatic drainage area. For lower esophageal
squamous cell carcinoma, CTV should involve middle and lower paraesophageal (8M and 8L),
subcarinal lymphatic drainage area.
Production of Planning Tumor Volume (PTV): PTV is produced by a margin of 5 mm added to CTV.
Prescription Dose: 50.4Gy/28f was prescribed to 95% PTV. Dosimetric Limitation: 95%
prescription dose should cover 100% PTV and 95% PTV should receive 100% prescription dose.
Total Lung: V20<25%, Dmean<13Gy, V5<50%. Spinal Cord: Dmax<45Gy. Heart: V30<40%, Dmean<25Gy.
Treatment Implementation: Radiotherapy is implemented every day. Conebeam CT should be
utilized per week to confirm set-up error.
Randomization All participants enrolled after postoperative radiotherapy would be randomly
assigned to the experimented arm and controlled arm.
Experimental Arm (Immunotherapy Maintenance) Participants enrolled into experimental arm were
prescribed to receive immunotherapy maintenance for one year.
Controlled Arm Participants enrolled into controlled arm began to be followed-up after
postoperative radiotherapy.
Follow-up: Participants should be follow-up every three months right after the completion of
radiotherapy or immunotherapy to 3 years after radiotherapy or immunotherapy. Then follow-up
every half year is allowed to 5 years after radiotherapy or immunotherapy. After 5 years,
follow-up every year is appropriate. In follow-up, chest CT and abdominal ultrasonography
should be implemented.
Primary endpoint: 1-year disease-free survival (RECIST V1.1) Secondary endpoint: Rate of
irradiation-induced or immune-induced pneumonitis, 3-year disease-free survival and 3-year
overall survival.
