Clinical trial · Interventional
A Study Of Moderately Hypo-Fractionated External-beam Radiotherapy With Concurrent Chemotherapy and High Dose Rate Brachytherapy In Cervical Cancer
A Prospective Phase II Study Of Moderately Hypo-Fractionated External-beam Radiotherapy With Concurrent Chemotherapy and High Dose Rate Brachytherapy In Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Carcinoma Stage II | Cervical Carcinoma | CURATED_BROADER | 0.78 |
| Cervical Carcinoma Stage IIB | Cervical Carcinoma | CURATED_BROADER | 0.78 |
| Cervical Carcinoma Stage III | Cervical Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| moderate hypofractionation external beam radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- participants
- description
- 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
- interventionNames
- Radiation: moderate hypofractionation external beam radiotherapy
Primary outcomes (1)
- measure
- tumor response rate
- timeFrame
- two years
- description
- 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
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older. 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: * 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.
References
Publications (0)
Data not yet available