Cervical CancerRAPPALNCT03997110
Palliative Radiation for Advanced Cervical Cancer
A study testing Short course palliative radiation. and Long course palliative treatment. in people with Cervical Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Short course palliative radiation. and Long course palliative treatment.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteIndia
- Study dates
- 19 Jun 2020to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Moderate to Severe Pain on Numerical Rating Score (Score 4 or higher).
- Anticipated survival < 12 months.
- 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.
Who cannot join
- Patients with distant metastasis needing upfront systemic therapy.
- Presence of retroviral disease
- Non-compliant for follow up.
- Expected survival <3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Supriya Sastri
About this study
Official title: Rapid Palliation in Locally Advanced Cervical Cancer: A Phase III Randomized 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.
Read the detailed description
This is a prospective randomised open label Phase III study. This study is 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. The primary objective of the study is pain relief in the experimental arm as compared to the control arm from treatment until 12 weeks from start of radiotherapy. Patients with locally advanced cervical cancer (Stage III B-IV A) deemed unsuitable for full course radical pelvic radiotherapy or chemoradiation, patients whose anticipated survival is less than 12 months will be included in the study. Patients with distant metastasis and those with retroviral disease will be excluded from the study. The patients will be randomised in one of the two groups:
Arm A : Control Arm - Long Course Palliative Radiation: Week 1: All the patients will receive external sitting of radiation treatment, first fraction of 10 Gy. Week 4: All the patients will receive external sitting of radiation treatment, second fraction of 10 Gy. Week 7: 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 which 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.
Arm B: Experimental arm- Short Course Palliative radiation. Week 1: Patients 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.There is no potential direct benefit to the study participants. However the aim is to use the available information to evolve treatment in future. The variables to be estimated are pain relief, disease related symptoms relief, CTCAE Toxicity, Quality of Life,overall survival and compliance to therapy.
- Conditions
- Cervical Cancer
- Being tested
- Short course palliative radiation., Long course palliative treatment.
- Keywords
- Cervical Cancer, Palliative treatment, Radiation Therapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short course palliative radiation.Radiation
Week 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.Radiation
Week1: 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
| Study group | Role | What they receive |
|---|---|---|
| Arm A Or Control Arm- Long course palliative treatment. | Active comparator | Week1: 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 Receives: Radiation: Long course palliative treatment. |
| Arm B or Experimental Arm-Short course palliative radiation. | Experimental | Week 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. Receives: Radiation: Short course palliative radiation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week, 4 week, 7 week, 12 weeks
Secondary outcomes (11)
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:
- Pain score of 0-3- No to mild pain ii) Pain score 4-7- Moderate pain iii) Pain score >7- Severe pain
Measured: 6 months, 9 months, 12 months
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.
Measured: 1 week,4 week,7week,12 weeks
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.
Measured: 12 weeks, 3 month, 9 month, 12 month
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.
Measured: 7 week,12 week, 3 month, 9 month, 12 month
Quality of Life using EORTC QLQC30 questionnaires
Quality of Life using EORTC QLQC 30 questionnaire (European Organisation for Research \& Treatment of Cancer - Quality of Life Questionnaire of Cancer patients) will be evaluated at start of radiotherapy and at week 12, 3 month, 6 month, 9 month,12 months follow up.
Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4.
1 will be considered as better outcome \& 4 will be considered as worst outcome.
Measured: At start of radiotherapy, 12 week and at 3, 6, 9 & 12 months follow up.
Quality of Life using EORTC QLQC-15 Pall questionnaires
Quality of Life using EORTC QLQC-15 Pall (European Organisation for Research \& Treatment of Cancer - Quality of Life Questionnaire in Palliative Cancer care patients) will be evaluated at start of radiotherapy and at week 12, 3 month, 6 month, 9 month,12 months follow up.
Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4.
1 will be considered as better outcome \& 4 will be considered as worst outcome.
Measured: At start of radiotherapy, 12 week and at 3, 6, 9 & 12 months follow up.
Quality of Life using Cx-24 questionnaires
Quality of Life using Cx-24 questionnaires (European Organisation for Research \& Treatment of Cancer - Quality of Life Questionnaire of Cervical cancer patients) will be evaluated at start of radiotherapy and at week 12, 3 month, 6 month, 9 month,12 months follow up.
Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4.
1 will be considered as better outcome \& 4 will be considered as worst outcome.
Measured: At start of radiotherapy, 12 week and at 3, 6, 9 & 12 months follow up.
Acute gastrointestinal and genitourinary toxicities
Acute gastrointestinal and genitourinary toxicities using CTCAE ver4.0 grading will be measured within 90 days of Radiotherapy.
Measured: Within 90 days of Radiotherapy
Late gastrointestinal and genitourinary toxicities
Late gastrointestinal and genitourinary toxicities using CTCAE 4.0 grading will be measured after 90 days of Radiotherapy.
Measured: After 90 days of Radiotherapy
Overall survival, defined as time from randomization until death due to any cause.
Overall survival, defined as time from randomization until death due to any cause.
Measured: 1 year
Patterns of terminal event (Due to local relapse or Distant Metastasis)
Events leading to death will be determined by telephonic interview of the relatives at 3, 6, 9 or 12 months, as applicable to find out the terminal cause of death.
Measured: By telephonic interview of the relatives at 3, 6, 9 or 12 months, as applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start19 Jun 2020
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, Randomized, Active Controlled Trial
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Collaborators
- Tata Memorial Centre
- Responsible party
- Principal investigator, Supriya Sastri (chopra), Tata Memorial Hospital
- Investigators
- Supriya Sastri, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997110
- Sponsor's protocol ID
- TMH IRB 3157
- Acronym
- RAPPAL
- Status last verified
- Feb 2026
- First submitted
- 9 Apr 2019
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Palliation in Locally Advanced Cervical Cancer: A Phase III Randomized Trial
- ClinicalTrials.gov ID
- NCT03997110
- Acronym / sponsor ID
- RAPPAL / TMH IRB 3157
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Palliative treatment, Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Tata Memorial HospitalOther government
- Collaborators
- Tata Memorial Centre
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective randomised open label Phase III study. This study is 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. The primary objective of the study is pain relief in the experimental arm as compared to the control arm from treatment until 12 weeks from start of radiotherapy. Patients with locally advanced cervical cancer (Stage III B-IV A) deemed unsuitable for full course radical pelvic radiotherapy or chemoradiation, patients whose anticipated survival is less than 12 months will be included in the study. Patients with distant metastasis and those with retroviral disease will be excluded from the study. The patients will be randomised in one of the two groups:
Arm A : Control Arm - Long Course Palliative Radiation: Week 1: All the patients will receive external sitting of radiation treatment, first fraction of 10 Gy. Week 4: All the patients will receive external sitting of radiation treatment, second fraction of 10 Gy. Week 7: 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 which 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.
Arm B: Experimental arm- Short Course Palliative radiation. Week 1: Patients 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.There is no potential direct benefit to the study participants. However the aim is to use the available information to evolve treatment in future. The variables to be estimated are pain relief, disease related symptoms relief, CTCAE Toxicity, Quality of Life,overall survival and compliance to therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III, Randomized, Active Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Arm A Or Control Arm- Long course palliative treatment. | Active comparator | Radiation: Long course palliative treatment.Week1: 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 |
| Arm B or Experimental Arm-Short course palliative radiation. | Experimental | Radiation: Short course palliative radiation.Week 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Locally advanced cervical cancer (Stage IIIB-IVA) deemed unsuitable for full course radical pelvic radiotherapy or chemoradiation due to the following reasons:
- Moderate to Severe Pain on Numerical Rating Score (Score 4 or higher).
- Anticipated survival < 12 months.
- 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.
Key exclusion criteria (4 listed)
- Patients with distant metastasis needing upfront systemic therapy.
- Presence of retroviral disease
- Non-compliant for follow up.
- Expected survival <3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short course palliative radiation.Week 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. | Radiation | Arm B or Experimental Arm-Short course palliative radiation. |
| Long course palliative treatment.Week1: 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 | Radiation | Arm A Or Control Arm- Long course palliative treatment. |
Primary outcome
Pain Relief (Numerical pain rating scale will be used)
Time frame: 1 week, 4 week, 7 week, 12 weeks
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
11 secondary outcomes
Pain Relief (Numerical pain rating scale will be used)
Time frame: 6 months, 9 months, 12 months
Presence or absence of vaginal bleeding and/or discharge and relief in vaginal bleeding (as reported by the patient)
Time frame: 1 week,4 week,7week,12 weeks
Change in use of analgesics (WHO ladder)
Time frame: 12 weeks, 3 month, 9 month, 12 month
Compliance to therapy
Time frame: 7 week,12 week, 3 month, 9 month, 12 month
Quality of Life using EORTC QLQC30 questionnaires
Time frame: At start of radiotherapy, 12 week and at 3, 6, 9 & 12 months follow up.
Quality of Life using EORTC QLQC-15 Pall questionnaires
Time frame: At start of radiotherapy, 12 week and at 3, 6, 9 & 12 months follow up.
Quality of Life using Cx-24 questionnaires
Time frame: At start of radiotherapy, 12 week and at 3, 6, 9 & 12 months follow up.
Acute gastrointestinal and genitourinary toxicities
Time frame: Within 90 days of Radiotherapy
Late gastrointestinal and genitourinary toxicities
Time frame: After 90 days of Radiotherapy
Overall survival, defined as time from randomization until death due to any cause.
Time frame: 1 year
Patterns of terminal event (Due to local relapse or Distant Metastasis)
Time frame: By telephonic interview of the relatives at 3, 6, 9 or 12 months, as applicable
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Supriya Sastri principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short course palliative radiation. and Long course palliative treatment. in people with Cervical Cancer, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Supriya Chopra (02227405000 ext. 5113, supriyasastri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relief (Numerical pain rating scale will be used) (time frame: 1 week, 4 week, 7 week, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.