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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01627288
First received: June 21, 2012
Last updated: January 23, 2014
Last verified: January 2014
  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: Allocation: Non-Randomized
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:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Maximum tolerated dose of integrated boost radiation therapy, administered with IMRT technique with concurrent chemotherapy (cisplatin). [ Time Frame: 3 years after treatment ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Local-regional control with integrated boost radiation therapy (TTLR) [ Time Frame: 3 years following treatment ] [ Designated as safety issue: No ]
  • Time to distant recurrence (TTDR) [ Time Frame: 3 tears after treatment ] [ Designated as safety issue: No ]
  • Disease free survival(DFS). [ Time Frame: 3 years after treatment ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 3 years after treatment ] [ Designated as safety issue: No ]
  • The number of acute dose limiting toxicities (DLT). [ Time Frame: 6 weeks following 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.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:

    1. Acute Grade 3-4 enteritis or proctitis
    2. Acute Grade 3-4 bladder toxicity
    3. Acute Grade 4 dermatologic toxicity

  • The number of late dose limiting toxicities (DLT) [ Time Frame: 3 years following treatment ] [ Designated as safety issue: Yes ]
    Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.


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: Dose Level 1
2.4 Gy X 25 fractions = 60 Gy
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
Experimental: Boost Radiation: Dose level 2
2.6 Gy X 25 fractions = 65 Gy
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
Experimental: Boost Radiation: Dose level 3
2.8 Gy x 25 fractions = 70 Gy
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
Experimental: Experimental: Boost Radiation Dose Level 0

If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below.

Dose level 0: 2.2 Gy X 25 fractions = 55 Gy

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
  • Contraindication to chemotherapy or radiation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Junzo Chino, MD Duke Cancer Center/Radiation Oncology
  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 23, 2014
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 July 29, 2014