Palliative Radiation for Advanced Cervical Cancer
ConditionCervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorTata Memorial Hospital
About this trial
The present study is proposed to compare a rapid fractionation schedule of 1 week compared to a protracted schedule of 6-8 weeks for palliation for locally advanced cervical cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Moderate to Severe Pain on Numerical Rating Score (Score 4 or higher).
Disqualifiers
Patients with distant metastasis needing upfront systemic therapy.
Presence of retroviral disease
Non-compliant for follow up.
Expected survival <3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Short course palliative radiation.
RadiationWeek 1: Patients in the experimental arm will be treated with short course radiotherapy (25Gy/5#). The dose fractionation of 25 Gy in 5# over a week will be used. Week 4: Patients who have almost complete clinical response will be evaluated for brachytherapy will receive the appropriate brachytherapy procedure depending on the tumor response to a dose of 6-8Gy x 2-3#. The patients who will be found unsuitable for brachytherapy will be kept under observation. Week 12: After treatment completion, response assessment will be done using following parameters: • Pain assessment using numerical pain rating scale on 0-10 • Vaginal bleeding- yes/no • Vaginal discharge- yes/ no • Analgesic use- WHO ladder and dosing • QOL QC30, QLQC15 Pall, QLQC Cervix 24 • Disease response • Acute toxicity. Follow up: Patients follow up will be utilizing standard of care imaging and lab investigations used for the patients. Patients will be evaluated every 3 months for the study duration.
Long course palliative treatment.
RadiationWeek1: All the patients will receive external sitting of radiation treatment, first fraction of 10 Gy. Week4: All the patients will receive external sitting of radiation treatment, second fraction of 10 Gy. Week7: Patients who have almost complete clinical response will be evaluated for brachytherapy will receive the appropriate brachytherapy procedure depending on the tumor response to a dose of 6-8Gy x 2-3#.The patients who will be found unsuitable for brachytherapy will receive another sitting of external radiation, third fraction of 10 Gy. Week 12: After treatment completion response assessment will be done using following parameters: • Pain assessment using numerical pain rating scale on 0-10 • Vaginal bleeding- yes/ no • Vaginal discharge- yes/no • Analgesic use- WHO ladder and dosing • QOL QC30, QLQC15 Pall, QLQC Cervix 24 • Disease response • Acute toxicity
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Arm A Or Control Arm- Long course palliative treatment.Active comparator 1 intervention
Group B: Arm B or Experimental Arm-Short course palliative radiation.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain Relief (Numerical pain rating scale will be used)
Pain relief in the experimental arm as compared to the control arm from treatment until 12 weeks from start of radiotherapy will be assessed. Pain relief will be assessed at 12 weeks from start of radiotherapy. (Pain has been chosen as the primary endpoint as it is the primary complaint in almost 2/3 rd of patients. Numerical pain rating scale has been chosen for objective pain assessment as it is easy to use and has been proven to be a reliable tool in multiple studies. Pain score will be documented on 11-scale numerical pain rating scale (NRS) and qualified into one of the following categories: i)Pain score of 0-3- No to mild pain ii)Pain score 4-7- Moderate pain iii)Pain score \>7- Severe pain
Time frame
1 week, 4 week, 7 week, 12 weeksSecondary outcomes
1
Pain Relief (Numerical pain rating scale will be used)
Pain relief at 6, 9 and 12 month of follow up. Pain score will be documented on 11-scale numerical pain rating scale (NRS) and qualified into one of the following categories: i) Pain score of 0-3- No to mild pain ii) Pain score 4-7- Moderate pain iii) Pain score \>7- Severe pain
Time frame
6 months, 9 months, 12 months2
Presence or absence of vaginal bleeding and/or discharge and relief in vaginal bleeding (as reported by the patient)
Complete relief in vaginal bleeding and non-infectious discharge will be documented at 12 weeks from start of RT as reported by the patient. Although vaginal bleeding and discharge are also major presenting complaints, there is no standardized objective scale or criteria for measuring these in cancer patients. Vaginal discharge if present will be qualified as infectious or non-infectious. Infectious vaginal discharge will warrant antibiotic treatment.
Time frame
1 week,4 week,7week,12 weeks3
Change in use of analgesics (WHO ladder)
Change in use of analgesics by either dose adjustment or stepping up/down on the WHO ladder at 12 weeks.This will also be recorded at each clinical follow up.
Time frame
12 weeks, 3 month, 9 month, 12 month4
Compliance to therapy
Response of local disease will be assessed clinically at end of treatment and on every follow up. Response to RT will be determined on follow-up at 7 and 12 weeks in both the arms and phone call interviews when necessary for completeness in patients with poor compliance to follow up.
Time frame
7 week,12 week, 3 month, 9 month, 12 monthSponsors and contacts
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Tata Memorial Hospital
Lead sponsor
Tata Memorial Centre
Collaborator
Source ClinicalTrials.gov