Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer. ICORG 09-06

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01164150
First received: July 15, 2010
Last updated: April 16, 2014
Last verified: January 2014
  Purpose

Post-operative radiotherapy is internationally accepted as standard practice in the management of high-risk endometrial cancer1. Whilst it has no proven impact on overall survival it significantly increases local control.

Conventional radiotherapy techniques (3-dimensional) utilise a 3 or 4 field beam arrangement to target the pelvis in order to treat those areas at risk of recurrence: the vagina, the parametrium and the pelvic lymph nodes. However, when using such a technique it is not possible to avoid irradiating sensitive normal tissues such as the bowel and bladder.

Toxicity data from international randomised control trials in endometrial cancer report significantly more haematological, gastrointestinal, genitourinary and cutaneous toxicites (all grades) in those who received pelvic irradiation compared to those who did not2,3. These trials delivered radiotherapy using 2 or 3-dimensional techniques.

Intensity Modulated Radiation Therapy (IMRT) is a newer but established radiotherapy technique in many tumour sites that allows us to much more tightly conform the radiation. It uses computer-generated beams to produce radiotherapy volumes that can avoid irradiation of normal tissues in the pelvis.

There are no randomised studies reported in the literature that compare 3-dimensional pelvic irradiation with IMRT in patients who have had surgery for endometrial cancer. However there are several small studies that report considerable sparing of normal tissues using IMRT and when compared retrospectively with conventionally treated patients demonstrate marked reductions in acute gastrointestinal and genitourinary toxicity4.

By delivering post-operative radiotherapy to the pelvis using IMRT (as opposed to the standard 3-dimensional technique) it is anticipated that whilst local control and survival will be unaffected acute and late toxicity will be reduced.


Condition Intervention Phase
Endometrial Cancer
Gastrointestinal Complications
Radiation Toxicity
Urinary Complications
Radiation: 45 Gy/25 fractions
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Reduction in the incidence of ≥ grade 2 acute genitourinary (GU) and gastrointestinal (GI) toxicity according to NCI CTCAE v.3.0 [ Time Frame: 2015 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of late GI and GU toxicity according to NCI CTCAE v.3.0 [ Time Frame: 2015 ] [ Designated as safety issue: Yes ]
  • Feasibility of implementing pelvic nodal irradiation using intensity-modulated radiotherapy in gynecological cancer [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Establishment of an image-guided pathway for gynecological cancer radiotherapy [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Rate of loco-regional control as assessed by CT scan, MRI, and biopsy [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Quality of life as assessed using EORTC QLQ-C30 and EORTC QLQ Cervical Cancer Specific Module CX 24 questionnaires [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Rate of disease-free survival [ Time Frame: 2015 ] [ Designated as safety issue: No ]
  • Overall survival rate [ Time Frame: 2015 ] [ Designated as safety issue: No ]

Estimated Enrollment: 154
Study Start Date: March 2010
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm B
45 Gy/25# external beam pelvic radiotherapy delivered using intensity modulated radiotherapy (IMRT) followed by 11 Gy/2# vaginal vault brachytherapy
Radiation: 45 Gy/25 fractions
Arm A 45 Gy/25 fractions pelvic radiotherapy using 3D planned technique followed by 11Gy/2 fractions vaginal vault brachytherapy
Arm A Control
45 Gy/25# external beam pelvic radiotherapy delivered using a 3-dimensional planned technique followed by 11 Gy/2# vaginal vault brachytherapy
Radiation: 45 Gy/25 fractions
Arm A 45 Gy/25 fractions pelvic radiotherapy using 3D planned technique followed by 11Gy/2 fractions vaginal vault brachytherapy

Detailed Description:

Primary Objective:

• To compare the incidence of acute grade >2 GU and GI toxicity

Secondary Objectives:

  • To establish in the context of a clinical research study the feasibility of implementing pelvic nodal irradiation using IMRT in gynaecological cancer
  • To establish an Image-Guided pathway for gynaecological cancer radiotherapy incorporating

    • Set-up errors and optimal margins for set-up uncertainty
    • Investigation of effects of bladder filling and rectal preparation protocols on the planning target volume
  • To estimate the rate of loco-regional control
  • To evaluate Quality of Life
  • To estimate the rate of disease-free survival
  • To estimate the overall survival rate
  Eligibility

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

Inclusion Criteria:

  • Patients undergoing adjuvant pelvic radiotherapy for histologically confirmed endometrial adenocarcinoma / serous carcinoma / papillary serous carcinoma / mixed histology (adenocarcinoma and serous) and following AJCC 2009 grade/stage:

    • Grade 2: stage IB (LVSI +/or >60yrs)
    • Grade 3: stage IA and IB
    • Grade 1-3: Stage II and IIIA, IIIB and IIIC1
  • Surgery consisting of total hysterectomy, +/- bilateral salpingo-oophorectomy, +/- lymph node sampling
  • Staging with imaging of pelvis and abdomen (either MRI or CT)
  • ECOG PS 0-2
  • Age ≥ 18 years
  • Provision of written informed consent in line with ICH-GCP guidelines

Exclusion Criteria:

  • Previous radiotherapy to the pelvic region
  • Patients in whom adjuvant chemotherapy has been delivered prior to radiotherapy
  • History of inflammatory bowel disease
  • Previous hip replacement
  • Previous bowel surgery (excluding appendectomy)
  • Patients with other syndromes/conditions associated with increased radiosensitivity
  • The patient has or had other co-existing malignancies within the past 5 years other than non-melanoma skin cancer
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study or if it is felt by the research / medical team that the patient may not be able to comply with the protocol
  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: NCT01164150

Locations
Ireland
Saint Luke's Hospital Recruiting
Dublin, Ireland, 6
Contact: Contact Person    353-1-406-5000    Charles.Gillham@slh.ie   
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
Principal Investigator: Charles Gillham, MD Saint Luke's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT01164150     History of Changes
Other Study ID Numbers: CDR0000680805, ICORG-09-06, EU-21048
Study First Received: July 15, 2010
Last Updated: April 16, 2014
Health Authority: Ireland: Research Ethics Committee

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
radiation toxicity
gastrointestinal complications
urinary complications
recurrent endometrial carcinoma
endometrial adenocarcinoma
stage IA endometrial carcinoma
stage IB endometrial carcinoma
stage II endometrial carcinoma
stage IIIA endometrial carcinoma
stage IIIB endometrial carcinoma
stage IIIC endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Radiation Injuries
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014