Risks associated with Radiation Therapy to the Pelvis

(from RADIATION THERAPY ONCOLOGY GROUP. RTOG 0417/ A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA

Very Likely

Low blood counts causing easy bruising
Shortening and narrowing of the vagina
Pain with sexual intercourse
Tiredness near the end of treatment
Diarrhea
Nausea and/or vomiting
Stomach pain that feels like bad heartburn or an ulcer and that may make eating or drinking difficult (in rare cases, if you become dehydrated, you may need to receive fluids through your vein)
Poor digestion of food
Weight loss (in rare cases, if this is severe, you may need a tube placed into your stomach to provide nutrition)
Rectal irritation
Urinary frequency and difficulty
Loss of pubic hair
Reddening and irritation of the skin in the treatment area

Less Likely But Serious

Rectal ulcer
Bleeding or narrowing of the rectum
Bloody urine
Pain, bleeding, and/or blockage of the stomach or other parts of the digestive system
Ureteral (tube connecting kidneys to the bladder) obstruction
Fistula (opening) forming between pelvic tissues
Reproductive risks

This study may be harmful to an unborn child. Therefore, participants who are still menstruating and have not had a tubal ligation (tubes tied) must have a negative pregnancy test prior to participating in this study. The results will be made available to you prior to the initiation of this study. Ask about counseling and more information about preventing pregnancy. You should not nurse a baby while on this study. Radiation to the pelvis will cause infertility, and you will not be able to become pregnant after treatment. Young women will go through menopause, and medication will be given to help with the symptoms of menopause.

Risks and side effects related to Radiation Therapy (including IMRT) to the pelvis include those that are:

(from RTOG 0418/ A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis +/- Chemotherapy for Post-operative Patients with either Endometrial or Cervical Carcinoma

Likely

• Decrease in blood counts, which can lead to a risk of infection and bleeding
• Fatigue
• Diarrhea
• Rectal irritation
• Urinary frequency and painful urination
• Loss of pubic hair
• Darkening of skin
• Vaginal narrowing and shortening
• Painful intercourse

Less Likely, but Serious (9/20/06)

• Rectal bleeding
• Rectal ulcer
• Blood in urine
• Bowel obstruction
• Urethral obstruction
• Damage to the vaginal wall, which could lead to a fistula (abnormal passageway) between the bladder and the vagina or between the rectum and vagina