Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study (PARCERII)

April 10, 2025 updated by: Prachi Mittal, MD, Radiation Oncology, Tata Memorial Centre
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Maharahstra
      • Navi Mumbai, Maharahstra, India, 410210
        • Recruiting
        • Advanced Centre for Treatment Research and Education in Cancer (ACTREC)
        • Contact:
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  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.

Exclusion Criteria:

  1. Patients with macroscopic residual disease (R+ resection) postoperatively
  2. Patients requiring extended field radiotherapy (patients with involved para-aortic lymph nodes in cervical or endometrial cancer)
  3. Patients treated with chemotherapy for any prior malignancy at any time
  4. Patients treated with pelvic radiation previously
  5. Patients with human immunodeficiency virus infection
  6. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated Image guided External Beam Radiation
Adjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer.
Radiation: Hypofractionated Image guided External Beam Radiation Therapy (EBRT)

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.

Other Names:
  • Radiotherapy
Drug: Cisplatin
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.
Other Names:
  • Chemotherapy
Radiation: Vaginal brachytherapy
Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.
Other Names:
  • Brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Median follow up of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Control Rate at 3 years
Time Frame: Median follow up of 3 years
To report 3 year pelvic control rate (local and pelvic nodal) in patients receiving hypofractionated radiotherapy.
Median follow up of 3 years
Disease Free Survival at 3 years
Time Frame: Median follow up of 3 years
To report 3 year disease free survival in patients receiving hypo fractionated radiotherapy.
Median follow up of 3 years
Overall Survival at 3 years
Time Frame: Median follow up of 3 years
To report 3 year overall survival in patients receiving hypo fractionated radiotherapy.
Median follow up of 3 years
Acute Toxicities Evaluation
Time Frame: 3 months
Acute toxicity will be reported using CTCAE V. 5.0
3 months
Assessment of Quality of Life for cervical cancer patients
Time Frame: Median follow up of 3 years

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.
Median follow up of 3 years
Assessment of Quality of Life for endometrial cancer patients
Time Frame: Median follow up of 3 years

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.
Median follow up of 3 years
C-MOSES scoring
Time Frame: Median follow up of 3 years
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.
Median follow up of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Centre

Investigators

  • Principal Investigator: Dr. Prachi D Mittal, MD, Tata Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2023

Primary Completion (Estimated)

May 25, 2029

Study Completion (Estimated)

May 25, 2029

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3910
  • CTRI/2023/02/050123 (Registry Identifier: Clinical Trials Registry-India)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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