Uterine Cervical Neoplasms Clinical Trial
Official title:
Postoperative Concurrent Chemoradiotherapy Combined With Recombinant Human Endostatin for High-risk Early Stage Cervical Cancer: A Phase II Pilot Study (ChESS).
To assess the efficacy and safety of postoperative concurrent chemoradiotherapy combined with recombinant human endostatin (Endostar) in patients with high-risk early stage cervical cancer.
This is a pilot phase 2, single arm study to assess the efficacy and safety of concurrent
chemoradiotherapy combined with recombinant human endostatin (Endostar) in early stage
cervical cancer patients with high risk factor(s).
Postoperative pelvic radiotherapy starts 2-3 weeks after surgery. Intensity modulated
radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total
prescription dose of 45-50Gy to PTV region. The external beam radiotherapy should be
completed within 6 weeks. Concurrent chemotherapy consists of cisplatin (75 mg/m2, day 1-3)
and 5-fluorouracil (5-FU; 1000mg/m2/day, civ, day 1-4) for 2 cycles every 3 weeks.
Recombinant human endostatin (Endostar,15mg/m2/d, civ, d1-7) is applied 3 days before the
concurrent chemoradiotherapy for 2 cycles every 3 weeks.
Aimed to recruit total of 120 cases in this single arm study. The primary endpoint is 3-year
disease-free survival and acute toxicity. Secondary endpoints include time to distant
metastasis survival, local-regional recurrence free survival, 3 and 5-year overall survival,
and safety and tolerability. Quality of life will be evaluated with EORTC-Q30.
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