Cervical Carcinoma Stage IIINCT07343531
A Study Of Moderately Hypo-Fractionated External-beam Radiotherapy With Concurrent Chemotherapy and High Dose Rate Brachytherapy In Cervical Cancer
A study testing moderate hypofractionation external beam radiotherapy in people with Cervical Carcinoma Stage III and Cervical Carcinoma Stage IIB, run by Ain Shams University at 1 site in Egypt.
Trial summary
Cancer of the uterine cervix is one of the most common gynecologic cancer diagnosis and cause of death among gynecologic cancers worldwide .The two major histologic types of cervical cancer are squamous cell carcinoma, adenocarcinoma and the preinvasive disease that corresponds with these histologies share many of the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Carcinoma Stage III, Cervical Carcinoma Stage IIB, Cervical Carcinoma Stage II
- What is being tested?
- moderate hypofractionation external beam radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- International Federation of Gynecology and Obstetrics (FIGO) IB1 cervical cancers if not surgical candidates, but amenable to definitive chemoradiotherapy.
- FIGO Stage IB2, IB3, IIA or IIB cervical cancers
- FIGO stage IIIA, IIIB.
- 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.
- Histologically-confirmed invasive uterine cervical carcinoma of subtypes squamous cell, adenocarcinoma or adenosquamous cell.
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- 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) .
- Brachytherapy candidate.
- Eastern Cooperative Oncology Group (ECOG) performance status up to 2 .
Who cannot join
- 1.FIGO stage IA, IIIC2, IVA or IVB. 2.FIGO stage IIIC1 with node is equal or greater than 3 cm, common iliac node or greater than 2 radiologically suspicious nodes.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ainshams University
Cairo, Cairo Governorate
About this study
Official title: A Prospective Phase II Study Of Moderately Hypo-Fractionated External-beam Radiotherapy With Concurrent Chemotherapy and High Dose Rate Brachytherapy In Cervical Cancer
Cancer of the uterine cervix is one of the most common gynecologic cancer diagnosis and cause of death among gynecologic cancers worldwide .The two major histologic types of cervical cancer are squamous cell carcinoma, adenocarcinoma and the preinvasive disease that corresponds with these histologies share many of the same risk factors .
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.
Read the detailed description
The objective of this study is: to assess the clinical response (as a primary endpoint), acute and a two-year late toxicities (as a secondary endpoint) of moderately hypo-Fractionated external-beam radiotherapy with concurrent chemotherapy and high-dose rate brachytherapy in cervical cancer.
- Being tested
- moderate hypofractionation external beam radiotherapy
- Keywords
- cervical cancer hypofractionation EBRTH
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate hypofractionation external beam radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| participants | Experimental | 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 Receives: Radiation: moderate hypofractionation external beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response rate
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 visit then at regular follow up visits
Measured: two years
Secondary outcomes (4)
acute toxicity
Acute 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 radiotherapy
Measured: 3 months
Late toxicity
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. Late toxicities will be collected at 3 months after completion of radiotherapy till 2 years
Measured: 2 years
Progression free survival
Progression-free survival is defined as time from the date of treatment initiation to the date of progression, date of death from any cause, or date of last follow-up, whichever occurs first. Cancer progression can be identified during physical examination ,EUA ,clinically by imaging of any kind or biopsy within a time frame of 2 years .
Measured: 2 years
Overall survival
Overall survival is defined as time from date of treatment initiation to death from any reason or last follow-up ,whichever occurs first, with a time frame of 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Carcinoma Stage IIIStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective single-arm clinical trial to assess the clinical response, acute and a two-year late toxicities of moderately hypo-fractionated external-beam radiotherapy with concurrent chemotherapy and high-dose rate brachytherapy in cervical cancer. 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 .
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343531
- Sponsor's protocol ID
- MD221/2025
- Status last verified
- Dec 2025
- First submitted
- 1 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study Of Moderately Hypo-Fractionated External-beam Radiotherapy With Concurrent Chemotherapy and High Dose Rate Brachytherapy In Cervical Cancer
- ClinicalTrials.gov ID
- NCT07343531
- Acronym / sponsor ID
- MD221/2025
- Keywords
- cervical cancer hypofractionation EBRTH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer of the uterine cervix is one of the most common gynecologic cancer diagnosis and cause of death among gynecologic cancers worldwide .The two major histologic types of cervical cancer are squamous cell carcinoma, adenocarcinoma and the preinvasive disease that corresponds with these histologies share many of the same risk factors .
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.
Detailed description
The objective of this study is: to assess the clinical response (as a primary endpoint), acute and a two-year late toxicities (as a secondary endpoint) of moderately hypo-Fractionated external-beam radiotherapy with concurrent chemotherapy and high-dose rate brachytherapy in cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective single-arm clinical trial to assess the clinical response, acute and a two-year late toxicities of moderately hypo-fractionated external-beam radiotherapy with concurrent chemotherapy and high-dose rate brachytherapy in cervical cancer. 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 .
| Arm | Type | Receives |
|---|---|---|
| participants | Experimental | Radiation: moderate hypofractionation external beam radiotherapy30 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older.
- International Federation of Gynecology and Obstetrics (FIGO) IB1 cervical cancers if not surgical candidates, but amenable to definitive chemoradiotherapy.
- FIGO Stage IB2, IB3, IIA or IIB cervical cancers
- FIGO stage IIIA, IIIB.
- 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.
Key exclusion criteria (4 listed)
- 1.FIGO stage IA, IIIC2, IVA or IVB. 2.FIGO stage IIIC1 with node is equal or greater than 3 cm, common iliac node or greater than 2 radiologically suspicious nodes.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moderate hypofractionation external beam radiotherapy30 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. | Radiation | participants |
Primary outcome
tumor response rate
Time frame: two years
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 visit then at regular follow up visits
4 secondary outcomes
acute toxicity
Time frame: 3 months
Late toxicity
Time frame: 2 years
Progression free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moderate hypofractionation external beam radiotherapy in people with Cervical Carcinoma Stage III and Cervical Carcinoma Stage IIB, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manar Adel, master degree (+201066760941, manar.adel@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response rate (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.