Cervical CancerPARCERIINCT05857631
Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
A study testing Hypofractionated Image guided External Beam Radiation Therapy (EBRT), Cisplatin and Vaginal brachytherapy in people with Cervical Cancer and Endometrial Cancer, run by Tata Memorial Centre at 2 sites in India.
Trial summary
The primary aim of the trial is to investigate the late effects of hypofractionated external radiation (39 Gy in 13 fractions) in patients requiring post-operative radiation for early-stage cervical and endometrial cancers. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer
- What is being tested?
- Hypofractionated Image guided External Beam Radiation Therapy (EBRT), Cisplatin and Vaginal brachytherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesIndia
- Study dates
- 29 May 2023to 25 May 2029
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Histologically confirmed diagnosis of cervical cancer post hysterectomy with intermediate or high-risk features, requiring adjuvant EBRT ± concurrent chemotherapy OR histologically confirmed diagnosis of endometrial cancer post hysterectomy requiring adjuvant (chemo)radiotherapy to pelvis with/without vaginal brachytherapy.
Who cannot join
- Patients with macroscopic residual disease (R+ resection) postoperatively
- Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)
- Patients treated with chemotherapy for any prior malignancy at any time
- Patients treated with pelvic radiation previously
- Patients with human immunodeficiency virus infection
- Any preexisting medical conditions that may interfere with the assessment of genitourinary or gastrointestinal toxicity (This includes patients with irritable bowel syndrome, subacute intestinal obstruction, anal incontinence, hemorrhoids precluding analysis of gastro-intestinal toxicities, urinary incontinence, recurrent urinary tract infections)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Prachi Mittal, MD, +912224177000 ext. 7033, mittalprachi@gmail.com
- Recruiting
Advanced Centre for Treatment Research and Education in Cancer (ACTREC)
Navi Mumbai, Maharahstra, 410210
Prachi Mittal, MD, +912224177000 ext. 7033, mittalprachi@gmail.com
About this study
The primary aim of the trial is to investigate the late effects of hypofractionated external radiation (39 Gy in 13 fractions) in patients requiring post-operative radiation for early-stage cervical and endometrial cancers.
Read the detailed description
This is a phase II prospective study that will be accruing patients with post operative cervical or endometrial cancer requiring adjuvant pelvic radiation.
External beam radiotherapy (Intensity modulated radiotherapy/arc technique) will be delivered to pelvis to a dose of 39 Gray (Gy) in 13 fractions at 3 Gy per fraction, delivered once daily over 2.5 - 3 weeks. Treatment will be delivered with Intensity Modulated Radiotherapy (IMRT) under image guidance. Patients for whom concurrent chemotherapy is indicated (as per adverse risk features) will receive concurrent weekly cisplatin (40mg/m2) based on standard institutional protocol. All patients with post-operative cervical cancer will receive vaginal brachytherapy after the completion of external beam radiation. Patients with endometrial cancer with certain pre defined risk factors will also receive vaginal brachytherapy. The dose of vaginal brachytherapy will be 6 Gy high dose rate brachytherapy delivered as two different fractions, one week apart. Patients will be evaluated by the concerned investigators on a weekly basis during radiation therapy and all the toxicities will be documented according to the CTCAE V 5.0.
Patients will be followed up 3 monthly for the first 2 years, then 6 monthly from years 2 - 5, and annually thereafter. CTCAE version 5 will be used for toxicity grading at each follow-up. Quality of life assessment will be performed at baseline prior to the start of radiation and on follow-up at pre-specified times using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and Cervix - 24 (CX24) for cervical cancer patients and Endometrium 24 (EN24) for endometrial cancer patients.
- Conditions
- Cervical Cancer, Endometrial Cancer
- Being tested
- Hypofractionated Image guided External Beam Radiation Therapy (EBRT), Cisplatin, Vaginal brachytherapy
- Keywords
- Hypofractionated Radiation, Radiotherapy, Adjuvant, Radiotherapy, Intensity modulated, Late gastrointestinal and genitourinary toxicities
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Image guided External Beam Radiation Therapy (EBRT)Radiation
Also called Radiotherapy
External beam radiotherapy to pelvis:
Post operative hypofractionated external beam radiotherapy with intensity modulated/arc technique, to a dose of 39 Gy in 13 fractions, at 3 Gy per fraction, delivered once daily, 5 days a week, over 2.5-3 weeks.
CisplatinDrug
Also called Chemotherapy
Patients who require adjuvant chemotherapy along with radiation, based on predefined risk features, will receive 5 cycles of cisplatin on a weekly basis with a dose of 40 mg/m2 by IV infusion over a period of 1 hour 2-4 hours prior to start of EBRT.
Vaginal brachytherapyRadiation
Also called Brachytherapy
Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Image guided External Beam Radiation | Experimental | Adjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer. Receives: Radiation: Hypofractionated Image guided External Beam Radiation Therapy (EBRT); Drug: Cisplatin; Radiation: Vaginal brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year cumulative incidence of grade ≥2 gastrointestinal or genitourinary toxicity
To evaluate the 3-year cumulative incidence of late grade ≥2 gastrointestinal or genitourinary toxicity using CTCAE version 5 scoring receiving radiation with hypo fractionation.
Measured: Median follow up of 3 years
Secondary outcomes (7)
Pelvic Control Rate at 3 years
To report 3 year pelvic control rate (local and pelvic nodal) in patients receiving hypofractionated radiotherapy.
Measured: Median follow up of 3 years
Disease Free Survival at 3 years
To report 3 year disease free survival in patients receiving hypo fractionated radiotherapy.
Measured: Median follow up of 3 years
Overall Survival at 3 years
To report 3 year overall survival in patients receiving hypo fractionated radiotherapy.
Measured: Median follow up of 3 years
Acute Toxicities Evaluation
Acute toxicity will be reported using CTCAE V. 5.0
Measured: 3 months
Assessment of Quality of Life for cervical cancer patients
To assess quality of life in using EORTC QLQ-C30 and CX24. Quality of life will be measured using the EORTC QLQ C-30. For cervical cancer, EORTC QLQ CX24 module will be used. QOL scoring will be done as per standard recommendations outlined in EORTC QLQ C30 scoring manual. All patients will undergo QOL evaluation at baseline, after treatment and at subsequent 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: Median follow up of 3 years
Assessment of Quality of Life for endometrial cancer patients
To assess quality of life in using EORTC QLQ-C30 and EN24. Quality of life will be measured using the EORTC QLQ C-30. For endometrial tumours, EORTC QLQ EN24 will be used. QOL scoring will be done as per standard recommendations outlined in EORTC QLQ C30 scoring manual. All patients will undergo QOL evaluation at baseline, after treatment and at subsequent 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: Median follow up of 3 years
C-MOSES scoring
To report cumulative toxicity score as assessed by C-MOSES scoring. Month and Severity Score (MOSES) will be calculated for each symptom (13 gastrointestinal and 6 genitourinary) with time weighted CTCAE toxicity, by using duration of time spent in each toxicity. Cumulative-MOSES score will be assessed for organ system (gastrointestinal and genitourinary), by summating MOSES of individual adverse event items respectively.
Measured: Median follow up of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start29 May 2023
- Primary completion25 May 2029 (estimated)
- Study completion25 May 2029 (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.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open-label phase II trial investigating the cumulative incidence of late grade ≥2 gastro-intestinal or genito-urinary toxicities in patients receiving adjuvant hypofractionated external beam radiotherapy to the pelvis for post-operative cervical or endometrial cancer.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prachi Mittal, MD, Radiation Oncology, Tata Memorial Centre
- Investigators
- Dr. Prachi D Mittal, MD, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857631
- Sponsor's protocol ID
- 3910
- Other IDs
- CTRI/2023/02/050123
- Acronym
- PARCERII
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2023
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
- ClinicalTrials.gov ID
- NCT05857631
- Acronym / sponsor ID
- PARCERII / 3910
- Conditions
- Cervical Cancer, Endometrial Cancer
- Keywords
- Hypofractionated Radiation, Radiotherapy, Adjuvant, Radiotherapy, Intensity modulated, Late gastrointestinal and genitourinary toxicities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 25 May 2029 (estimated)
- Study completion
- 25 May 2029 (estimated)
- First posted
- 12 May 2023 (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 primary aim of the trial is to investigate the late effects of hypofractionated external radiation (39 Gy in 13 fractions) in patients requiring post-operative radiation for early-stage cervical and endometrial cancers.
Detailed description
This is a phase II prospective study that will be accruing patients with post operative cervical or endometrial cancer requiring adjuvant pelvic radiation.
External beam radiotherapy (Intensity modulated radiotherapy/arc technique) will be delivered to pelvis to a dose of 39 Gray (Gy) in 13 fractions at 3 Gy per fraction, delivered once daily over 2.5 - 3 weeks. Treatment will be delivered with Intensity Modulated Radiotherapy (IMRT) under image guidance. Patients for whom concurrent chemotherapy is indicated (as per adverse risk features) will receive concurrent weekly cisplatin (40mg/m2) based on standard institutional protocol. All patients with post-operative cervical cancer will receive vaginal brachytherapy after the completion of external beam radiation. Patients with endometrial cancer with certain pre defined risk factors will also receive vaginal brachytherapy. The dose of vaginal brachytherapy will be 6 Gy high dose rate brachytherapy delivered as two different fractions, one week apart. Patients will be evaluated by the concerned investigators on a weekly basis during radiation therapy and all the toxicities will be documented according to the CTCAE V 5.0.
Patients will be followed up 3 monthly for the first 2 years, then 6 monthly from years 2 - 5, and annually thereafter. CTCAE version 5 will be used for toxicity grading at each follow-up. Quality of life assessment will be performed at baseline prior to the start of radiation and on follow-up at pre-specified times using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and Cervix - 24 (CX24) for cervical cancer patients and Endometrium 24 (EN24) for endometrial cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open-label phase II trial investigating the cumulative incidence of late grade ≥2 gastro-intestinal or genito-urinary toxicities in patients receiving adjuvant hypofractionated external beam radiotherapy to the pelvis for post-operative cervical or endometrial cancer.
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Image guided External Beam Radiation | Experimental | Radiation: Hypofractionated Image guided External Beam Radiation Therapy (EBRT), Drug: Cisplatin, Radiation: Vaginal brachytherapyAdjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Histologically confirmed diagnosis of cervical cancer post hysterectomy with intermediate or high-risk features, requiring adjuvant EBRT ± concurrent chemotherapy OR histologically confirmed diagnosis of endometrial cancer post hysterectomy requiring adjuvant (chemo)radiotherapy to pelvis with/without vaginal brachytherapy.
Key exclusion criteria (6 listed)
- Patients with macroscopic residual disease (R+ resection) postoperatively
- Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)
- Patients treated with chemotherapy for any prior malignancy at any time
- Patients treated with pelvic radiation previously
- Patients with human immunodeficiency virus infection
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 |
|---|---|---|
| Hypofractionated Image guided External Beam Radiation Therapy (EBRT)Also: RadiotherapyExternal beam radiotherapy to pelvis: Post operative hypofractionated external beam radiotherapy with intensity modulated/arc technique, to a dose of 39 Gy in 13 fractions, at 3 Gy per fraction, delivered once daily, 5 days a week, over 2.5-3 weeks. | Radiation | Hypofractionated Image guided External Beam Radiation |
| CisplatinAlso: ChemotherapyPatients who require adjuvant chemotherapy along with radiation, based on predefined risk features, will receive 5 cycles of cisplatin on a weekly basis with a dose of 40 mg/m2 by IV infusion over a period of 1 hour 2-4 hours prior to start of EBRT. | Drug | Hypofractionated Image guided External Beam Radiation |
| Vaginal brachytherapyAlso: BrachytherapyVaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart. | Radiation | Hypofractionated Image guided External Beam Radiation |
Primary outcome
3-year cumulative incidence of grade ≥2 gastrointestinal or genitourinary toxicity
Time frame: Median follow up of 3 years
To evaluate the 3-year cumulative incidence of late grade ≥2 gastrointestinal or genitourinary toxicity using CTCAE version 5 scoring receiving radiation with hypo fractionation.
7 secondary outcomes
Pelvic Control Rate at 3 years
Time frame: Median follow up of 3 years
Disease Free Survival at 3 years
Time frame: Median follow up of 3 years
Overall Survival at 3 years
Time frame: Median follow up of 3 years
Acute Toxicities Evaluation
Time frame: 3 months
Assessment of Quality of Life for cervical cancer patients
Time frame: Median follow up of 3 years
Assessment of Quality of Life for endometrial cancer patients
Time frame: Median follow up of 3 years
C-MOSES scoring
Time frame: Median follow up of 3 years
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 15 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Dr. Prachi D Mittal, MD principal investigator
Tata Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Image guided External Beam Radiation Therapy (EBRT), Cisplatin and Vaginal brachytherapy in people with Cervical Cancer and Endometrial Cancer, run by Tata Memorial Centre at 2 sites 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 2 inclusion and 6 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 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Dr. Prachi D Mittal, MD (+91 9004938871, mittalprachi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year cumulative incidence of grade ≥2 gastrointestinal or genitourinary toxicity (time frame: Median follow up of 3 years). 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 15 Apr 2025.