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Completed

NCT Number: NCT01627288

Integrated Dose Escalation for Advanced, Localized Gynecologic Cancer (The IDEAL - GYN Trial)

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

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Key information

Conditions

Cancer of the Cervix CERVICAL NEOPLASMS Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Radiation Oncology, DUMC

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy confirmed malignancy of the gynecologic tract
  • Involved pelvic or para-aortic lymph nodes
  • Treatment plan to include delivery of concurrent chemoradiotherapy.
  • 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
  • A history of Scleroderma or Inflammatory bowel disease
  • Contraindication to chemotherapy or radiation

Treatment and study plan

Boost radiation

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

Primary outcomes

  1. Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).

    Time frame: During RT to 6 weeks post RT

    Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy.

Secondary outcomes

  1. Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)

    Time frame: 3 years following treatment

    Local-regional control is defined as local control without any nodal recurrence.

  2. Time to Distant Recurrence (TTDR)

    Time frame: 3 years after treatment

  3. Disease Free Survival (DFS)

    Time frame: 3 years after treatment

  4. Overall Survival (OS)

    Time frame: 3 years after treatment

  5. Number of Participants With Acute Dose Limiting Toxicities (DLT)

    Time frame: 6 weeks following treatment

    Acute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin.Since integrated radiation dose escalation is unlikely to substantially affect the hematopoietic system, only non-hematologic, grade 3-4, acute toxicity will be considered the primary dose-limiting toxicity (acute DLT). 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, Acute Grade 4 dermatologic toxicity.

  6. Number of Participants With Late Dose Limiting Toxicities (DLT)

    Time frame: 3 years following treatment

    Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: IDEAL

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Jun 25, 2012
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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