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Integrated Dose Escalation for Advanced, Localized Cervical Cancer (The IDEAL - Cervix Trial)

This study is currently recruiting participants.
Verified January 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01627288
First received: June 21, 2012
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).


Condition Intervention
Cancer of the Cervix
Cervical Neoplasms
 Radiation: Boost radiation

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Dose Escalation for Advanced, Localized Cervical Cancer (The IDEAL - Cervix Trial)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of dose limiting radiation (DLT) induced toxicities [ Time Frame: Six weeks after treatment ] [ Designated as safety issue: Yes ]

    Acute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin. Dose limiting toxicity will include any of the following during treatment or within 6 weeks of completion:

    1. Acute Grade 3-4 enteritis or proctitis
    2. Acute Grade 3-4 bladder toxicity
    3. Grade 4 dermatologic toxicity (skin necrosis or ulceration of full thickness of dermis)


Estimated Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Boost Radiation Radiation: Boost radiation
Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3). This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy confirmed carcinoma of the cervix
  • Involved pelvic or para-aortic lymph nodes
  • Treatment plan to include delivery of concurrent Cisplatin with curative intent.
  • Good performance status
  • Negative pregnancy test in women of child-bearing potential
  • Signed study-specific informed consent
  • Lab results within study specific limits

Exclusion Criteria:

  • Prior radiation to the abdomen or pelvis
  • Prior hysterectomy
  • A history of Scleroderma or Inflammatory bowel disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627288

Locations
United States, North Carolina
Radiation Oncology, DUMC Recruiting
Durham, North Carolina, United States, 27710
Contact: Junzo Chino, MD     919-668-7336     junzo.chino@dm.duke.edu    
Contact: Eileen Duffy, RN     919 6683726     eileen.duffy@dm.duke.edu    
Principal Investigator: Junzo Chino, MD            
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01627288     History of Changes
Other Study ID Numbers: Pro00033820
Study First Received: June 21, 2012
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 17, 2013