Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer (TOMOGYN)

Centre Oscar Lambret

Status: Terminated

Conditions: Endometrial Cancer

Treatments: Radiation: IMRT; Radiation: 3D conformational radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01641497

TOMOGYN - 1105

2011-A01543-38 (Other Identifier)

Details and patient eligibility

About

Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.

Full description

Endometrial cancer is the most common form of gynecological cancer in France with 6560 new cases in 2010. Endometrial cancers occurs generally after menopause but are sometimes diagnosticated before 40 years. The 5 years Overall survival of endometrial cancer is 76% (95% for non locally advanced or non metastatic disease).

Some factors are involved in disease prognostic: age, geographical origin, physical status, tumor grade, tumor histology and probably biomarkers. Some studies demonstrated that advanced age is a negative prognostic factor due to higher relapse risk and higher specific mortality. Unfortunately, Incidence of endometrial cancer will probably increase in future due to aging of the occidental population.

Current treatment of endometrial cancer is based on post-operative radiation therapy: adjuvant brachytherapy or adjuvant external beam radiation therapy. However these techniques lead to serious toxicity (digestive toxicity, ileitis...) in elder patient. Consequently, pelvic radiation therapy is difficult to organize before 75 years and dangerous to perform after 80 years.

However a new technique called: Intensity-modulated radiation therapy (IMRT) can make the difference. IMRT is a new high precision radiotherapy technique probably well adapted for old people, with less toxicity than current radiotherapy.

Nevertheless, IMRT is not recognized as a standard radiation therapy procedure in France and Europe.

Thus, goal of TOMOGYN study is to compare the tolerance of old women (at least 70 years), with endometrial cancer, treated with external beam radiation therapy or IMRT.

Enrollment: 26 patients

Sex: Female

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• endometrial adenocarcinoma histologically proven
• post op pelvic radiotherapy
• age ≥ 70
• performance status ≤ 2
• MMSE ≥ 10
• life expectancy ≥ 3 months
• social security covered
• signed informed consent

Exclusion criteria

• type I stade IAGI and stade IAGIII without myometer infiltration, stade IIIc2 and IV adenocarcinoma
• uterine sarcoma
• surgery not in accordance with recommendations of Inca
• previous uncontrolled or less than 5 years prior to diagnosis cancer
• cons-indication for radiotherapy
• diarrhea ≥ 3 per day
• pelvic lymph nodes > 1cm not resected during staging
• previous sigmoid diverticulitis, crohn disease, systemic disease, ulcerative haemorrhagic, collagenosis, infectious peritonitis
• IMRT other than tomotherapy
• photon energy < 10MV
• patient under guardianship

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

26 participants in 2 patient groups

3D conformational radiotherapy

Active Comparator group

Description:

25 \* 1.8 Gy in 5 weeks (=45 Gy). 3D conformational radiation

Treatment:

Radiation: 3D conformational radiation

Intensity-Modulated Radiation Therapy

Experimental group

Description:

25 \* 1.8 Gy in 5 weeks (=45 Gy). IMRT

Treatment:

Radiation: IMRT