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

NCT05857631 | Recruiting DMC

• 2 other identifiers: 3910CTRI/2023/02/050123
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervical Cancer; Endometrial Cancer

Keywords

Hypofractionated Radiation; Radiotherapy, Adjuvant; Radiotherapy, Intensity modulated; Late gastrointestinal and genitourinary toxicities

Outcome Measures

Primary Outcomes (1)

• 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.

  Median follow up of 3 years

Secondary Outcomes (7)

• Pelvic Control Rate at 3 years

  Median follow up of 3 years

• Disease Free Survival at 3 years

  Median follow up of 3 years

• Overall Survival at 3 years

  Median follow up of 3 years

• Acute Toxicities Evaluation

  3 months

• Assessment of Quality of Life for cervical cancer patients

  Median follow up of 3 years

Study Arms (1)

Hypofractionated Image guided External Beam Radiation

EXPERIMENTAL

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

Radiation: Hypofractionated Image guided External Beam Radiation Therapy (EBRT); Drug: Cisplatin; Radiation: Vaginal brachytherapy

Interventions

Hypofractionated Image guided External Beam Radiation Therapy (EBRT) RADIATION

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.

Also known as: Radiotherapy

Hypofractionated Image guided External Beam Radiation

Cisplatin DRUG

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.

Also known as: Chemotherapy

Hypofractionated Image guided External Beam Radiation

Vaginal brachytherapy RADIATION

Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.

Also known as: Brachytherapy

Hypofractionated Image guided External Beam Radiation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (2)

Advanced Centre for Treatment Research and Education in Cancer (ACTREC)

Navi Mumbai, Maharahstra, 410210, India

RECRUITING

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms

Interventions

Radiotherapy; Cisplatin; Drug Therapy; Brachytherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Dr. Prachi D Mittal, MD

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Prachi D Mittal, MD

CONTACT

+91 9004938871; mittalprachi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 12, 2023
• Study Start: May 29, 2023
• Primary Completion (Estimated): May 25, 2029
• Study Completion (Estimated): May 25, 2029
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)