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

Phase 2
18 Years
Open (Enrolling)
Endometrial Cancer, Gastrointestinal Complications, Radiation Toxicity, Urinary Complications

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Trial Information

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

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

- 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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

Charles Gillham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Luke's Hospital


Ireland: Research Ethics Committee

Study ID:




Start Date:

March 2010

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Gastrointestinal Complications
  • Radiation Toxicity
  • Urinary Complications
  • 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
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma
  • Radiation Injuries