Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT04070976|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : September 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Radiation: Hypofractionated therapy Radiation: Standard therapy||Not Applicable|
The primary endpoint will be to assess the safety and efficacy to concomitant chemoradiotherapy followed by brachytherapy in cervical cancer clinical stage III. Secondary endpoints comprises security profile, survival rates, quality of life and related costs.
The data obtained by this protocol will allow to determine the effect of hypofractionated radiation therapy and its possible adverse effects. Side effects will be classified according to version 4.03 of CTCAE guidelines. The highest CTCAE grade will be obtained for each type of event, for each patient and the Radiation Therapy Oncology Group (RTOG) scale will be applied to evaluate the events related to conventional and hypofractionated radiotherapy, as well as brachytherapy.
Quality of life (QOL) will be evaluated using EORTC QLQ-CX24 and EORTC QLQ-C30, both have been validated and available in Mexican Spanish.
Direct and indirect expenses related to the treatment will be evaluated based on the treatment costs stipulate by the institution and the information obtained by the social workers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Randomized Controlled Trial of Concomitant Chemoradiotherapy With Standard Fractionation Compared to Hypofractionated Concomitant Chemoradiotherapy Followed by Brachytherapy, for Clinical Stage III Cervical Cancer Patients|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||July 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Active Comparator: Standard treatment
Cisplatin 40mg/m2 weekly and concomitant pelvic radiotherapy (45 Gray/25 fractions) followed by brachytherapy 28Gray at point A.
Radiation: Standard therapy
All patients will be treated with external beam radiotherapy with 50 Gray in 25 fractions (1.8-2 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using anterior/posterior fields and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
Experimental: Experimental treatment
Cisplatin 40mg/m2 weekly and hypofractionated concomitant external radiotherapy (37,50 Gray/15 fractions) followed by brachytherapy 28 Gray at point A.
Radiation: Hypofractionated therapy
All patients will be treated with an external beam of 37.5 Gray in 15 fractions (2.5 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using the anterior/posterior field and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
- Acute and late toxicity [ Time Frame: 2 years ]Number of Participants With Treatment-Related Adverse Events as Assessed by RTOG
- Treatment efficacy [ Time Frame: 2 years ]Hypofractionated radiotherapy is similar in toxicity and disease control compared to standard external beam treatment
- Disease-free survival rate [ Time Frame: 2 years ]Number of participants dead of disease at two years according to kaplan-meyer analysis
- Overall survival rate [ Time Frame: 2 years ]Number ofpParticipants dead at two years according to kaplan-meyer analysis
- Satisfaction assessed by EORTC [ Time Frame: 2 years ]Assessed individual's overall satisfaction with life and general sense of personal well-being by ERTC QLQ-C30 and QLQ-CX24 questionaire
- Direct and indirect costs related to treatment. [ Time Frame: 2 years ]Direct costs related to the treatment. Indirect costs related to the treatment (transport, housing, food, etc.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04070976
|Contact: David F Cantú-de León, Md, MSc. PhDfirstname.lastname@example.org|
|Contact: Lenny N Gallardo-Alvarado, MD, MScemail@example.com|
|David Cantu de Leon||Recruiting|
|Mexico City, Tlalpan, Mexico, 14080|
|Contact: David F Cantu-de Leon, MD. Msc. Phd +5215537093116 firstname.lastname@example.org|
|Principal Investigator:||David F Cantú-deLeón||Instituto Nacional de Cancerología|