TP006/#1423 Addchemo CC trial – adjuvant treatment in plasma HPV-DNA positive patients: a biomarker for chemotherapy in locally advanced cervical cancer

Abstract

Objectives This study hypothesizes that patients with locally advanced cervical cancer (CC) who persist with positive expression of plasma cell‐free HPV‐DNA (cfDNA‐HPV) after standard chemoradiation treatment, may derive benefit of using adjuvant chemotherapy. Thus, the objectives are: ‐ Primary Objectives: To assess the progression free survival (PFS) of patients with advanced CC undergoing adjuvant chemotherapy from a biomarker. ‐ Secondary objectives: To assess response rate, overall survival, and treatment toxicity. Methods Multicentric, experimental, prospective study. The participants will receive the conventional treatment based on concomitant radiochemotherapy (ChRT), characterizing the descriptive phase of the research. In the second phase, the randomization of the study will be carried out, outlining an experimental study. Inclusion Criteria: Patients with CC FIGO 2018 IB3 to IVA, 18 years or older, immunocompetent, HPV types 16 or 18 positive in cervical tumor and plasma at diagnosis and adequate liver and kidney function. Patients should receive standard ChRT (EBRT 40‐50Gy, brachytherapy 30‐40Gy and weekly cisplatin). Four weeks after the end of treatment, plasma cfDNAHPV will be performed. Those with a negative result will start an observation protocol, with imaging and clinical examination every four months in the first two years and every six months in the third year. Patients with positive cfDNA‐HPV, will be randomized to receive two additional cycles of adjuvant chemotherapy with cisplatin 50 mg/m2 D1 and gemcitabine 1000 mg/m2 D1 and D8 every 21 days or observation. Results Trial in progress: there are no available results at the time of submission. Conclusions Trial in progress: there are no available conclusions at the time of submission.