Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study

Lawson Health Research Institute

Status and phase: Enrolling; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: Concurrent Chemotherapy; Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care; Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT04583254

HEROICC

ReDA ID#10482 (Other Identifier)

Details and patient eligibility

About

External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 3 or 4 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer.

This study investigates the role of shortened external radiotherapy regimen (hypofractionated radiotherapy) by randomizing patients to this experimental regimen versus the standard of care.The purpose of this study is to access the feasibility of patient accrual to this trial in the Canadian setting and to provide an initial evaluation of cancer response and treatment tolerability.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older

• International Federation of Gynecology and Obstetrics (FIGO) IA or IB1 cervical cancers if not surgical candidates, but amenable to definitive chemoradiotherapy as proposed in this trial.

• FIGO Stage IB2, IB3, IIA or IIB cervical cancers

• FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria:

  1. largest node is less than 3 cm
  2. less than 3 pathological nodes
  3. No nodes located in the common iliac chain.
  4. Cervical confined or with parametrial invasion

• Histologically-confirmed invasive uterine cervical carcinoma of subtypes squamous cell, adenocarcinoma or adenosquamous cell

• Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin

• Brachytherapy candidate

Exclusion criteria

• FIGO stage IIIA, IIIB, IIIC2, IVA or IVB
• FIGO stage IIIC1 with node greater than 3 cm, common iliac node or greater than 2 pathological nodes
• Previous pelvic or abdominal radiotherapy
• Patients requiring paraaortic nodal irradiation
• Inflammatory bowel disease
• Connective tissue disorder (eg. scleroderma, systemic lupus erythematous)
• Neuroendocrine, glassy cell, small cell, adenoid cystic carcinoma, adenoid basal carcinoma, clear cell, serous, endometrioid, verrucous carcinoma, melanoma, and sarcoma histologies
• Patient unable to undergo MR scan
• Eastern Cooperative Oncology Group (ECOG) performance status greater than 3
• Not a cisplatin candidate

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental

Experimental group

Treatment:

Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental

Drug: Concurrent Chemotherapy

Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care

Active Comparator group

Treatment:

Drug: Concurrent Chemotherapy

Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care