Daily Adaptive Radiation Therapy an Individualized Approach for Carcinoma of the Cervix

Conditions

• Cervical Cancer by FIGO Stage 2018

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Varian Ethos Adaptive Radiation Therapy — DEVICE
  Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

Study Details

This is a single-arm, prospective, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for locally advanced cervical cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT). The timepoint for this assessment will be at week 5 of external beam radiotherapy (EBRT) and will use the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Key Dates

Start date

May 3, 2022

Status verified

Sep 2025

Primary completion

Sep 30, 2028

Completion

Sep 30, 2030

Study Design

Enrollment

125 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Daily Adaptive External Beam Radiation Therapy
  Daily adaptive radiation therapy delivered with Varian Ethos treatment system.

Primary Outcome Measure

Acute Patient Reported Outcome (PRO) GI Toxicity [ Time Frame: End of external beam treatment delivery (week 5) ]

Central Contacts

• Heike Hausen, MD
  1-650-743-7400
  [email protected]
• Sean Davidson, MS
  [email protected]

Locations (5)

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