Shorter-course external-beam radiotherapy with weekly chemotherapy and high-dose-rate brachytherapy for cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients receive moderately hypofractionated external-beam radiotherapy given concurrently with weekly cisplatin (carboplatin AUC2 allowed if cisplatin is not tolerated), followed by high-dose-rate intracavitary brachytherapy. The primary outcome is clinical response, with secondary outcomes including acute toxicity and two-year late toxicity. Eligible participants include adults with histologically confirmed squamous, adenocarcinoma, or adenosquamous cervical cancer in specified FIGO stages, and selected IIIC1 nodes meeting size/number limits. The regimen is delivered at a single center (Ain Shams University) with protocol-specified imaging and toxicity monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ainshams University
  Cairo, Cairo Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Manar Adel, master degree
• Email: manar.adel@med.asu.edu.eg
• Phone: +201066760941

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.