The purpose of the study is to evaluate the role of hypofractionated in the treatment of locally advanced cervical cancer. The study will be conducted in Honduras and Mexico, and patients will be randomized to a standard fraction (45 Gy in 25 fractions) or hypofractionated (37.5Gy in 15 fractions) followed by surgery. Patients will receive weekly cisplatin with their treatments at 40 mg/m2. Response rate, survival, and toxicity will be evaluated.
Toxicity will be assessed six times during this study. In addition to the primary endpoint of patient-reported gastrointestinal toxicity, a broad range of other toxicities will be comprehensively evaluated, including urinary, hematologic and dermatologic, this data will allow to determining the effect of hypofractionated radiation therapy on each of these aspects of toxicity from pelvic radiation. Additionally, will be recognized that it is possible to advance in the understanding of the clinical risk and benefits of hypofractionation. The primary endpoint will be acute gastrointestinal toxicity using the Radiation Therapy Oncology Group (RTOG) common toxicity criteria. In total, evaluating toxicity in different time points will allow determining if hypofractionation is secure concerning acute and late toxicity, that would enable to offer an optional treatment to this kind of patient. Chronic gastrointestinal toxicity from radiation continues to increase rapidly over two years, and then the rate of developing new toxicities slows. As a result, the majority of chronic radiation-induced gastrointestinal toxicity by evaluating toxicity two years after completion of radiotherapy is going to be identified. Quality of life (QOL) will be evaluated using EORTC QLQ-CX24 and EORTC QLQ-C30, both of which have been validated and available in Mexican Spanish.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
External Bean Pelvic Radiation: 50 Gy in 15 fractions, with weekly cisplatin.
External Bean Pelvic Radiation: 37.5 Gy in 15 fractions, with weekly cisplatin.
Radical hysterectomy and pelvic and paraaortic lymph node resection
David Cantu de Leon
Mexico City, Tlalpan, Mexico
ACTIVE_NOT_RECRUITINGInstituto Nacional de Cancerologia
Mexico City, Mexico
RECRUITINGAcute and late toxicity.
Number of Participants With Treatment-Related Adverse Events as Assessed by RTOG
Time frame: 2 years
Overall survival
Number of Participants dead at two years according to kaplan-meyer analysis
Time frame: 2 years
disease specific survival
Number of Participants dead of disease at two years according to kaplan-meyer analysis
Time frame: 2 years
equivalent treatment
hypofractionated radiotherapy is similar in toxicity and disease control compared to standard external beam treatment.
Time frame: 2 years
Surgical complications
comparison of surgical complications between the two arms of treatment according to The Clavien-Dindo classification.
Time frame: 1 year
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