search
Back to results

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

Primary Purpose

Cervical Cancer, Endometrial Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypofractionated Image guided External Beam Radiation Therapy (EBRT)
Cisplatin
Vaginal brachytherapy
Sponsored by
Tata Memorial Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Hypofractionated Radiation, Radiotherapy, Adjuvant, Radiotherapy, Intensity modulated, Late gastrointestinal and genitourinary toxicities

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hypofractionated Image guided External Beam Radiation

    Arm Description

    Adjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Pelvic Control Rate at 3 years
    To report 3 year pelvic control rate (local and pelvic nodal) in patients receiving hypofractionated radiotherapy.
    Disease Free Survival at 3 years
    To report 3 year disease free survival in patients receiving hypo fractionated radiotherapy.
    Overall Survival at 3 years
    To report 3 year overall survival in patients receiving hypo fractionated radiotherapy.
    Acute Toxicities Evaluation
    Acute toxicity will be reported using CTCAE V. 5.0
    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.
    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.
    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.

    Full Information

    First Posted
    March 30, 2023
    Last Updated
    May 11, 2023
    Sponsor
    Tata Memorial Centre
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05857631
    Brief Title
    Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
    Acronym
    PARCERII
    Official Title
    Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 25, 2023 (Anticipated)
    Primary Completion Date
    May 25, 2026 (Anticipated)
    Study Completion Date
    May 25, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tata Memorial Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Endometrial Cancer
    Keywords
    Hypofractionated Radiation, Radiotherapy, Adjuvant, Radiotherapy, Intensity modulated, Late gastrointestinal and genitourinary toxicities

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypofractionated Image guided External Beam Radiation
    Arm Type
    Experimental
    Arm Description
    Adjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer.
    Intervention Type
    Radiation
    Intervention Name(s)
    Hypofractionated Image guided External Beam Radiation Therapy (EBRT)
    Other Intervention Name(s)
    Radiotherapy
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Other Intervention Name(s)
    Chemotherapy
    Intervention Description
    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.
    Intervention Type
    Radiation
    Intervention Name(s)
    Vaginal brachytherapy
    Other Intervention Name(s)
    Brachytherapy
    Intervention Description
    Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.
    Primary Outcome Measure Information:
    Title
    3-year cumulative incidence of grade ≥2 gastrointestinal or genitourinary toxicity
    Description
    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.
    Time Frame
    Median follow up of 3 years
    Secondary Outcome Measure Information:
    Title
    Pelvic Control Rate at 3 years
    Description
    To report 3 year pelvic control rate (local and pelvic nodal) in patients receiving hypofractionated radiotherapy.
    Time Frame
    Median follow up of 3 years
    Title
    Disease Free Survival at 3 years
    Description
    To report 3 year disease free survival in patients receiving hypo fractionated radiotherapy.
    Time Frame
    Median follow up of 3 years
    Title
    Overall Survival at 3 years
    Description
    To report 3 year overall survival in patients receiving hypo fractionated radiotherapy.
    Time Frame
    Median follow up of 3 years
    Title
    Acute Toxicities Evaluation
    Description
    Acute toxicity will be reported using CTCAE V. 5.0
    Time Frame
    3 months
    Title
    Assessment of Quality of Life for cervical cancer patients
    Description
    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.
    Time Frame
    Median follow up of 3 years
    Title
    Assessment of Quality of Life for endometrial cancer patients
    Description
    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.
    Time Frame
    Median follow up of 3 years
    Title
    C-MOSES scoring
    Description
    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.
    Time Frame
    Median follow up of 3 years

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr. Prachi D Mittal, MD
    Phone
    +91 9004938871
    Email
    mittalprachi@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr. Prachi D Mittal, MD
    Organizational Affiliation
    Tata Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs