Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer

Sponsor

National Institute of Cancerología (Other)

Overall Status

Recruiting

CT.gov ID

NCT04070976

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main goal of this trial is to assess the safety and response rate to concomitant chemotherapy and external hypofractionated radiotherapy followed by brachytherapy in patients with clinical stage III cervical cancer. The trial will take place in the National Cancer Institute (INCan). Patients will be randomized into two groups: chemotherapy with external standard fractionated radiotherapy (45 Gy in 25 fractions) followed by brachytherapy or chemotherapy with external hypofractionated radiotherapy (37.5 Gy in 15 fractions) followed by brachytherapy.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Radiation: Hypofractionated therapy Radiation: Standard therapy	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Jul 1, 2019

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Acute and late toxicity [2 years]
Number of Participants With Treatment-Related Adverse Events as Assessed by RTOG

Secondary Outcome Measures

Treatment efficacy [2 years]
Hypofractionated radiotherapy is similar in toxicity and disease control compared to standard external beam treatment
Disease-free survival rate [2 years]
Number of participants dead of disease at two years according to kaplan-meyer analysis
Overall survival rate [2 years]
Number ofpParticipants dead at two years according to kaplan-meyer analysis
Satisfaction assessed by EORTC [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. [2 years]
Direct costs related to the treatment. Indirect costs related to the treatment (transport, housing, food, etc.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women over 18 years old
Cervical Cancer at IIIA, IIIB y IIIC1 FIGO´s clinical stages
Histology: squamous, adenosquamous or adenocarcinoma
No previous treatment
No distance metastases, discard by Positron Emission Tomography (PET)/CT
Functional State ECOG (Eastern Cooperative Oncology Group) 0-2
Complete Blood count obtained at least 14 days before admission to the study with adequate bone marrow function defined as:
Absolute neutrophil count ≥ 1,500 cell/mm3
Platelets ≥ 100,000 cell/mm3
Hemoglobin ≥ 10.0 g/dl
Leukocyte count ≥ 4000 cell/mm3
Adequate Renal Function defined as:
Serum Creatinine ≤ 1.5 mg/dl within 14 days before admission to the study
Patients with HIV infection (human immunodeficiency virus) must have a CD4 cell count ≥ 350 cells / mm3 measured within 14 days prior to study entry (no HIV test is required)
The patient must understand the protocol and provide the specific informed consent of the study before admission
Negative pregnancy test

Exclusion Criteria:

Patients who had chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies
Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum (For example, breast cancer or oral cavity cancer)
Previous systemic chemotherapy for current cervical cancer, take into account that prior chemotherapy for a different cancer is accepted, as long as they have been at least 3 years
Severe active or non-controlled co-morbidities, defined as:
Unstable angina and/or congestive heart failure that required hospitalization in the last 6 months.
Transmural myocardial infarction in the last 6 months.
Acute bacterial or fungal infection requiring intravenous antibiotics at the beginning of the study.
Chronic obstructive pulmonary disease exacerbation or another respiratory disease that requires hospitalization or that contraindicates the trial therapy at the time of admission.
Crohn's disease or ulcerative colitis.
Prior allergic reaction to cisplatin or other drugs based on platinum.
Other factors that contraindicate experimental therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	David Cantu de Leon	Mexico City	Tlalpan	Mexico	14080

Sponsors and Collaborators

National Institute of Cancerología

Investigators

Principal Investigator: David F Cantú-deLeón, Instituto Nacional de Cancerología

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Human papillomavirus (HPV) and cervical cancer [Internet]

Publications

Responsible Party:

David Cantu, Chief of clinical trials department, National Institute of Cancerología

ClinicalTrials.gov Identifier:

NCT04070976

Other Study ID Numbers:

019/036/ICI

First Posted:

Aug 28, 2019

Last Update Posted:

Sep 2, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by David Cantu, Chief of clinical trials department, National Institute of Cancerología

hypofractionated radiotherapy

Brachytherapy

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Sep 2, 2020