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


N/A
18 Years
N/A
Open (Enrolling)
Female
Cancer of the Cervix, Cervical Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of dose limiting radiation (DLT) induced toxicities

Outcome Description:

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

Outcome Time Frame:

Six weeks after treatment

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

Pro00033820

NCT ID:

NCT01627288

Start Date:

June 2012

Completion Date:

June 2020

Related Keywords:

  • Cancer of the Cervix
  • Cervical Neoplasms
  • Neoplasms
  • Uterine Cervical Neoplasms

Name

Location

Radiation Oncology, DUMCDurham, North Carolina  27710