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NCT03634267 · ClinicalTrials.gov registry record · Phase 1

MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer

A Phase 1 study of Human Papillomavirus-Related Carcinoma and Human Papillomavirus-Related Cervical Carcinoma, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
Phase 1
Development phase
26
Enrollment target
1
Study location

NCT03634267: Active Phase 1 study of Human Papillomavirus-Related Carcinoma and Human Papillomavirus-Related Cervical Carcinoma, sponsored by M.D. Anderson Cancer Center.

NCT03634267 is a Phase 1 study of Human Papillomavirus-Related Carcinoma and Human Papillomavirus-Related Cervical Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 26 participants, below the 403-participant average among 7 other Human Papillomavirus-Related Carcinoma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03634267, a Phase 1 study of Human Papillomavirus-Related Carcinoma and Human Papillomavirus-Related Cervical Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
26 participants
Enrollment target
1
Study location

Study Summary

This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.

Primary Outcome

Rate will be compared to conventional guidance, with ultrasound and freehand technique. We will compare the HR-CTV D90 and other secondary dosimetry parameters (e.g. D2 cc bladder, D2 cc rectum etc.) between the initial scan (subsequent to ultrasound \[US\] guided or freehand applicator placement) and optimized (with magnetic resonance imaging \[MRI\] guided placement) treatment plan for each patient using McNemar's test.

Conditions Studied

Human Papillomavirus-Related Carcinoma Human Papillomavirus-Related Cervical Carcinoma Stage IB2 Cervical Cancer AJCC v8 Stage II Cervical Cancer AJCC v8 Stage II Vaginal Cancer AJCC v8 Stage IIA Cervical Cancer AJCC v8 Stage IIA Vaginal Cancer AJCC v8 Stage IIA1 Cervical Cancer AJCC v8 Stage IIA2 Cervical Cancer AJCC v8 Stage IIB Cervical Cancer AJCC v8

Interventions

  • PROCEDURE Magnetic Resonance Imaging
  • RADIATION Internal Radiation Therapy

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2018-08-03
Est. Completion 2026-12-31
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the registry record for NCT03634267 still lists

NCT03634267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 403-participant average among 7 other Human Papillomavirus-Related Carcinoma trials with a reported enrollment target (94% lower).

The record links to 10 conditions, with Human Papillomavirus-Related Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Magnetic Resonance Imaging is the first listed.

NCT03634267 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT03634267 about?

NCT03634267 is a clinical study titled "MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer". This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement ...

What is the current status of trial NCT03634267?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2018-08-03. Estimated completion is 2026-12-31.

What conditions does trial NCT03634267 study?

This clinical trial studies the following conditions: Human Papillomavirus-Related Carcinoma, Human Papillomavirus-Related Cervical Carcinoma, Stage IB2 Cervical Cancer AJCC v8, Stage II Cervical Cancer AJCC v8, Stage II Vaginal Cancer AJCC v8.

What interventions are being tested in trial NCT03634267?

The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Internal Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT03634267?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03634267 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT03634267, the US trial registry maintained by the National Library of Medicine. NCT03634267 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.