Comparing two radiation schedules for advanced cervical cancer treatment

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

This study aims to compare a rapid fractionation schedule of palliative radiation over one week with a protracted schedule lasting 6-8 weeks for patients with locally advanced cervical cancer. It is a prospective randomized open-label Phase III study focusing on pain relief as the primary outcome. Eligible patients include those with Stage IIIB-IV A cervical cancer who are not suitable for radical treatment due to various clinical factors. The study will assess the effectiveness of these two radiation schedules in alleviating pain over a 12-week period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Locally advanced cervical cancer (Stage IIIB-IVA) deemed unsuitable for full course radical pelvic radiotherapy or chemoradiation due to the following reasons:

   * Very large volume hard fixed disease infiltrating pelvic wall muscles and ligaments on clinical examination also classified clinically as "frozen pelvis" wherein curative intent treatment is not envisaged or feasible.
   * Fistulous communication between tumour growth and rectum and bladder \>2x2 cm in size (as judged by cystoscopy for bladder infiltration or clinical or proctosigmoidoscopy examination for rectal/sigmoid infiltration) wherein radical intent treatment is not intended or feasible and patient is not a candidate for pelvic exenteration.
   * Deranged renal parameters as measured by Serum Creatinine \>3 mg/dl wherein diversion nephrostomy is not planned by the multidisciplinary team due to anticipated poor clinical outcomes.Furthermore concurrence for palliative intent radiotherapy should be corroborated by 2 staff radiation oncologists.
2. Moderate to Severe Pain on Numerical Rating Score (Score 4 or higher).
3. Anticipated survival \< 12 months.
4. Patients with stage IVB with local disease extent as described in section 1 but systemic chemotherapy is not possible either due to deranged renal function or anticipated poor tolerance.

Exclusion Criteria:

1. Patients with distant metastasis needing upfront systemic therapy.
2. Presence of retroviral disease
3. Non-compliant for follow up.
4. Expected survival \<3 months.

Where it's running

• Tata Memorial Hospital
  Mumbai, Maharashtra, India Recruiting

Study contacts

• Principal investigator: Supriya Sastri — Tata Memorial Hospital
• Study coordinator: Supriya Chopra
• Email: supriyasastri@gmail.com
• Phone: 02227405000

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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.