A Study Of Moderately Hypo-Fractionated External-beam Radiotherapy With Concurrent Chemotherapy and High Dose Rate Brachytherapy In Cervical Cancer
NCT ID: NCT07343531
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-07-01
2027-06-30
Brief Summary
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Cancer cervix can be treated definitively with concurrent chemoradiation (external beam radiotherapy and chemotherapy) followed by high dose rate brachytherapy. Treatment duration can be shortened by increasing the dose per fraction of treatment, which can improve survival rates, reduce the risk of treatment failure, reduce costs and patient exposure.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
A phase II trial for patients histopathologically diagnosed as invasive cervical carcinoma with above mentioned eligibility criteria recruited from the gynecological oncology outpatient unit of a single center in Egypt, at the clinical oncology and nuclear medicine department, Ain Shams University Hospital.
The trial is a single-arm study (experimental group ): 30 patients will receive external beam radiotherapy (EBRT) 40 Gy / 16 fractions with additional 6:10 Gy boost on positive pelvic L.Ns if found either sequential or simultaneous integrated boost (SIB) (according to patient tolerability) with IMRT or VMAT technique followed by High-dose rate (HDR) Brachytherapy 28 Gy /4 fractions 7 Gy per fraction over 2 weeks .
TREATMENT
NONE
\- The tumor response rate on Magnetic resonance imaging (MRI) images will be graded as proposed in Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) to be done before start of the radiotherapy, at the last week of external beam radiotherapy and at 3 month-follow up visits then at regular follow up.
The secondary endpoints :
1-Acute and a two-year late toxicities are assessed by clinical assessment during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 . Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Haematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation.
Study Groups
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participants
30 patients will receive external beam radiotherapy (EBRT) 40 Gy / 16 fractions with additional 6:10 Gy boost on positive pelvic L.Ns if found either sequential or simultaneous integrated boost (SIB) (according to patient tolerability) with IMRT or VMAT technique followed by High-dose rate (HDR) Brachytherapy 28 Gy /4 fractions 7 Gy per fraction over 2 weeks
moderate hypofractionation external beam radiotherapy
30 patients will receive external beam radiotherapy (EBRT) 40 Gy / 16 fractions with additional 6:10 Gy boost on positive pelvic L.Ns if found either sequential or simultaneous integrated boost (SIB) (according to patient tolerability) with IMRT or VMAT technique followed by High-dose rate (HDR) Brachytherapy 28 Gy /4 fractions 7 Gy per fraction over 2 weeks.Concurrent weekly cisplatin 40 mg/m2 will be received .
-Concurrent weekly carboplatin AUC 2 will be received if cisplatin is not tolerated (creatinine clearance 40:60 ml/min) .
HDR brachytherapy boost will be given 28 Gy/ 4 fractions 7 Gy per fraction over 2 weeks to be started within a week after the end of external beam radiotherapy sessions.
Interventions
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moderate hypofractionation external beam radiotherapy
30 patients will receive external beam radiotherapy (EBRT) 40 Gy / 16 fractions with additional 6:10 Gy boost on positive pelvic L.Ns if found either sequential or simultaneous integrated boost (SIB) (according to patient tolerability) with IMRT or VMAT technique followed by High-dose rate (HDR) Brachytherapy 28 Gy /4 fractions 7 Gy per fraction over 2 weeks.Concurrent weekly cisplatin 40 mg/m2 will be received .
-Concurrent weekly carboplatin AUC 2 will be received if cisplatin is not tolerated (creatinine clearance 40:60 ml/min) .
HDR brachytherapy boost will be given 28 Gy/ 4 fractions 7 Gy per fraction over 2 weeks to be started within a week after the end of external beam radiotherapy sessions.
Eligibility Criteria
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Inclusion Criteria
2. International Federation of Gynecology and Obstetrics (FIGO) IB1 cervical cancers if not surgical candidates, but amenable to definitive chemoradiotherapy.
3. FIGO Stage IB2, IB3, IIA or IIB cervical cancers
4. FIGO stage IIIA, IIIB.
5. FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria (to avoid extented field technique ): The largest radiologically suspicious positive pelvic node is less than 3 cm. Less than 3 radiologically suspicious positive nodes. No suspicious nodes located in the common iliac chain.
6. Histologically-confirmed invasive uterine cervical carcinoma of subtypes squamous cell, adenocarcinoma or adenosquamous cell.
7. Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin (Creatinine clearance more than 60 ml/min). Carboplatin AUC 2 is acceptable alternative if cisplatin is not tolerated (creatinine clearance 40:60 ml/min) .
8. Brachytherapy candidate.
9. Eastern Cooperative Oncology Group (ECOG) performance status up to 2 .
Exclusion Criteria
3.Previous pelvic or abdominal radiotherapy. 4.Active inflammatory bowel disease. 5.Active connective tissue disorder (eg. scleroderma, systemic lupus erythematous).
6.Patient unable to undergo MR scan 7.Eastern Cooperative Oncology Group (ECOG) performance status equal to 3 or more.
8.Creatinine clearance less than 40 ml/min.
18 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Locations
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Ainshams University
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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Other Identifiers
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MD221/2025
Identifier Type: -
Identifier Source: org_study_id
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