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

NCT01164150 | Terminated Phase 2

• 2 other identifiers: CTRIAL-IE (ICORG) 09-06EU-21048
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Endometrial Cancer; Gastrointestinal Complications; Radiation Toxicity; Urinary Complications

Keywords

gastrointestinal complications; urinary complications; radiation toxicity; 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

Outcome Measures

Primary Outcomes (1)

• Reduction in the incidence of ≥ grade 2 acute genitourinary (GU) and gastrointestinal (GI) toxicity according to NCI CTCAE v.3.0

  2015

Secondary Outcomes (7)

• Incidence of late GI and GU toxicity according to NCI CTCAE v.3.0

  2015

• Feasibility of implementing pelvic nodal irradiation using intensity-modulated radiotherapy in gynecological cancer

  2015

• Establishment of an image-guided pathway for gynecological cancer radiotherapy

  2015

• Rate of loco-regional control as assessed by CT scan, MRI, and biopsy

  2015

• Quality of life as assessed using EORTC QLQ-C30 and EORTC QLQ Cervical Cancer Specific Module CX 24 questionnaires

  2015

Study Arms (2)

Arm B

EXPERIMENTAL

Radiation: 45 Gy / 25 fractions pelvic radiotherapy using intensity modulated radiotherapy (IMRT) followed by 11 Gy / 2 fractions vaginal vault brachytherapy

Radiation: 45 Gy/25 fractions

Arm A Control

OTHER

Radiation: 45 Gy/25 fraction external beam pelvic radiotherapy delivered using a 3-dimensional planned technique followed by 11 Gy / 2 fractions vaginal vault brachytherapy

Radiation: 45 Gy/25 fractions

Interventions

45 Gy/25 fractions RADIATION

Arm A 45 Gy/25 fractions pelvic radiotherapy using 3D planned technique followed by 11Gy/2 fractions vaginal vault brachytherapy

Arm A Control; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous radiotherapy to the pelvic region
• Patients in whom concurrent chemotherapy in planned
• Patients with macroscopic disease in situ
• 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

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (5)

St Luke's Radiation Oncology Network (SLRON) Centres

Dublin, 6, Ireland

Location

St Luke's Centre for Radiation Oncology at Beaumont Hospital

Dublin, Ireland

Location

St Luke's Centre for Radiation Oncology at St James Hospital

Dublin, Ireland

Location

St Luke's Centre for Radiation Oncology at St Lukes Hospital

Dublin, Ireland

Location

Mid-Western Radiation Oncology Centre

Limerick, Ireland

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Wounds and Injuries

Study Officials

• Charles Gillham, Dr

  Saint Luke's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: March 1, 2010
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IE (5)