Comparing two radiation schedules for advanced cervical cancer treatment

Rapid Palliation in Locally Advanced Cervical Cancer: A Phase III Randomized Trial

This study is testing whether a quick week-long radiation treatment can help relieve pain better than a longer 6-8 week schedule for patients with advanced cervical cancer who can't have surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Tata Memorial Hospital (Government)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Mumbai, Maharashtra)
• Trial ID: NCT03997110 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with locally advanced cervical cancer (Stage IIIB-IVA) who are not suitable for full course radical pelvic radiotherapy or chemoradiation.

Not a fit: Patients with distant metastasis or those with retroviral disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and quicker palliative treatment option for patients suffering from advanced cervical cancer.

How similar studies have performed: Other studies have shown varying success with different radiation schedules for palliative care, but this specific approach is novel.

Eligibility criteria

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 this trial is running

Mumbai, Maharashtra

• Tata Memorial Hospital — Mumbai, Maharashtra, India (Recruiting)

Study contacts

• Principal investigator: Supriya Sastri — Tata Memorial Hospital
• Study coordinator: Supriya Chopra

Conditions Cervical Cancer; Palliative treatment; Radiation Therapy