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Trial Title:
Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study
NCT ID:
NCT05857631
Condition:
Cervical Cancer
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Cisplatin
Conditions: Keywords:
Hypofractionated Radiation
Radiotherapy, Adjuvant
Radiotherapy, Intensity modulated
Late gastrointestinal and genitourinary toxicities
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Hypofractionated Image guided External Beam Radiation Therapy (EBRT)
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.
Arm group label:
Hypofractionated Image guided External Beam Radiation
Other name:
Radiotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
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.
Arm group label:
Hypofractionated Image guided External Beam Radiation
Other name:
Chemotherapy
Intervention type:
Radiation
Intervention name:
Vaginal brachytherapy
Description:
Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.
Arm group label:
Hypofractionated Image guided External Beam Radiation
Other name:
Brachytherapy
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.
Criteria for eligibility:
Criteria:
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)
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Advanced Centre for Treatment Research and Education in Cancer (ACTREC)
Address:
City:
Navi Mumbai
Zip:
410210
Country:
India
Status:
Recruiting
Contact:
Last name:
Prachi Mittal, MD
Phone:
+912224177000
Phone ext:
7033
Email:
mittalprachi@gmail.com
Facility:
Name:
Tata Memorial Hospital
Address:
City:
Mumbai
Zip:
400012
Country:
India
Status:
Recruiting
Contact:
Last name:
Prachi Mittal, MD
Phone:
+912224177000
Phone ext:
7033
Email:
mittalprachi@gmail.com
Start date:
May 29, 2023
Completion date:
May 25, 2029
Lead sponsor:
Agency:
Tata Memorial Centre
Agency class:
Other
Source:
Tata Memorial Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05857631
