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Submitted by: Dr. Aveline Marie Du Ylanan 2020-07-25 12:42:30 Last Updated by: Principe, Jeverly Ann S 2020-07-27 16:01:04


Gastrointestinal and genitourinary toxicities in two different dose fractionation regimens of high dose rate intracavitary brachytherapy (7Gy x 4 fractions vs 8Gy x 3 fractions) for carcinoma of the uterine cervix: A phase II trial

PHRR200727-002772

Unspecified

Unspecified

Gastrointestinal and genitourinary toxicities in two different dose fractionation regimens of high dose rate intracavitary brachytherapy (7Gy x 4 fractions vs 8Gy x 3 fractions) for carcinoma of the uterine cervix: A phase II trial

Prospective, randomized, phase II study

Population (n=60)

1. Biopsy-confirmed squamous cell carcinoma of the uterine cervix)
2. Stage IIB (≧4 cm in diameter) - IIIB disease (FIGO 2018)
3. Age; 20-70 years
4. PS; WHO 0-2
5. No prior chemotherapy, radiotherapy, and surgery to the pelvis
6. Adequate bone marrow, hepatic, and renal functions upon entry into the study
7. Diagnostic images (CT of the abdomen and pelvis is needed, MRI of the pelvis is recommended but not mandatory) before starting EBRT
8. Without para-aortic lymph node (PALN) metastasis on CT (> 1 cm in minimum diameter)

Randomized to 

  1. 7Gy x 4 weekly fractions

  2. 8Gy x 3 weekly fractions

Primary Outcome

Late (2-year) GI (rectum, bowel) and GU (bladder) morbidities measured using the RTOG/EORTC morbidity scoring scheme in brachytherapy regimens of 8Gy x 3 fractions and 7Gy x 4 fractions

 

Regime Classification Priority
2017 - 2022 Responsive health systems Health service delivery
Start Date Duration in Months Target Completion Date Actual Completion Date
2020-10-05 48 2024-10-05 0000-00-00

Suspended

COVID-19 Pandemic

Institution Classification Region LTO #
Philippine General Hospital Government NCR
Institution Region
Self-funded None
Name E-Mail Institution and Institution Address
Aveline Ylanan adylanan@up.edu.ph Cancer Institute, Philippine General Hospital, Taft Ave., Ermita, Manila
Name E-Mail Institution and Institution Address
Aveline Ylanan adylanan@up.edu.ph Cancer Institute, Philippine General Hospital, Taft Ave., Ermita, Manila
Name Expertise Affiliation
Aveline Marie D. Ylanan, MD Radiation Oncology Philippine General Hospital
Jean Anne B. Toral, MD, MSc Gynecologic Oncologist Philippine General Hospital
Maria Patricia Angelica M. Tanchuling, MD Gynecologic Oncology Philippine General Hospital
Miriam Joy C. Calaguas, MD Radiation Oncologist Philippine General Hospital
Nonette A. Cupino, MD Radiation Oncology Philippine General Hospital
Reno Eufemon P. Cereno, MD Radiation Oncology Philippine General Hospital
Project Location Institutional Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board

Cervical Cancer

 

Late (2-year) GI (rectum, bowel) and GU (bladder) morbidities measured using the RTOG/EORTC morbidity scoring scheme in brachytherapy regimens of 8Gy x 3 fractions and 7Gy x 4 fractions

Clinic-socio-demographic profiles
Acute (< 6 months) GI and GU morbidities measured using the RTOG/EORTC morbidity
scoring scheme
Acute (< 6 months) and late (2 years) GI and GU morbidities in brachytherapy regimens of 8Gy x 3 fractions and 7Gy x 4 fractions
2-year disease control and survival rates
a. Local control (nil recurrence of disease in the cervix)
b. Cancer specific survival (Time from 1st day of treatment to death from cervical cancer)
c. Disease-free survival (Time from 1st day of treatment to any signs or symptoms of cancer)
d. Overall survival (Time from 1st day of treatment to death from any cause)

Pending

  • Philippines

Clinical Trial

Unspecified

Unspecified

0000-00-00

0000-00-00

60

Unspecified

Unspecified

05 Oct 2020

Inclusion:

1. Biopsy-confirmed squamous cell carcinoma of the uterine cervix
2. Stage IIB (≧4 cm in diameter) - IIIB disease (FIGO 2018)
3. Age; 20-70 years
4. PS; WHO 0-2
5. No prior chemotherapy, radiotherapy, and surgery to the pelvis
6. Adequate bone marrow, hepatic, and renal functions upon entry into the study; a. WBC≧3000/mm3
b. Hb≧10 g/dl
c. Platelet≧100,000/mm3
d. Total bilirubin≦1.5 mg/dl
e. AST/ALT≦2 times upper limit of normal
f. Serum creatinine≦1.5 mg/dl 7. Diagnostic images (CT of the abdomen and pelvis is needed, MRI of the pelvis is recommended but not mandatory) before starting EBRT.
8. Without para-aortic lymph node (PALN) metastasis on CT. (> 1 cm in minimum diameter)

Exclusion:

1. Severe concomitant illness
2. History of other malignancies within the past 5 years except basal cell carcinoma or squamous cell carcinoma in-situ of the skin
3. Patients who are pregnant or lactating
4. Patients who are not active members of the Philippine Health Insurance Corporation

Interventional

Radiotherapy

1. External beam radiotherapy using linear accelerator (LINAC) machine
2. Image-guided intracavitary brachytherapy

None

Randomized

Open Label

Unspecified

Parallel

Cervical cancer is commonly treated with concurrent chemoradiation, with radiation given via external beam radiotherapy (EBRT) and brachytherapy. The past decade saw a shift from low-dose-rate (LDR) to high-dose-rate (HDR) brachytherapy due to a number of advantages. HDR brachytherapy is given in multiple weekly fractions, and is performed either after completion of the whole EBRT course, or interspersed among the EBRT fractions to limit the duration of all radiotherapeutic interventions to eight weeks.

Several fractionation regimens are used in HDR brachytherapy. However, it is currently unclear whether the regimen of 8Gy x 3 fractions of HDR brachytherapy would result in more significant gastrointestinal (GI) and genitourinary (GU) morbidities, compared to the more commonly used regimen of 7Gy x 4 fractions. There is a need to establish the long-term safety and effectivity of an 8Gy x 3 fractions regimen in the era of image-guided brachytherapy (IGBT) which utilizes computed tomography (CT) imaging.

Limiting brachytherapy to a three-fraction regimen will not only make it more convenient for the patient, but also reduce demand on staff and equipment time. For patients, the economic and psychosocial burden of undergoing numerous outpatient brachytherapy fractions can be reduced if the said fractionation is to be utilized. From a public health perspective, high volume centers from low- income countries can accommodate more cervical cancer patients if the number of brachytherapy fractions can be reduced. Healthcare costs can also be significantly minimized. Cervical cancer remains to be one of the most common malignancies in the Philippines.

Phase II

Utilization Utilization Info
Publication

Upon completion of the study, the investigators plan to submit the manuscript for publication to relevant scientific journals.

Oral Presentation

Upon completion of the study, the investigators plan to submit the abstract for oral or poster presentation at scientific meetings. The data will also be shared with the group of Filipino radiation oncologists, focusing on those interested in improving access to brachytherapy in underserved areas in the country.

Drug Literature

N/A

Posters
Others
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