ICON8 Trial summary

Recruitment into the ICON8 trial took place between 06/06/2011 and 31/04/2014.

ICON8 is an international trial comparing weekly chemotherapy with 3 weekly chemotherapy for women with ovarian cancer, fallopian tube cancer or primary peritoneal cancer.*

Ovarian cancer is usually treated by a combination of surgery and chemotherapy. The chemotherapy used for ovarian cancer is usually a combination of two drugs, carboplatin and paclitaxel (which is also known as Taxol) given for 6 cycles. This treatment is internationally considered to be a standard of care for ovarian cancer. Each cycle of treatment is given over a 3 week period. A cycle includes the time when the chemotherapy is given and then a break before the next treatment to allow the body to recover.

Recent studies have suggested that giving chemotherapy more frequently than once every 3 weeks is also effective. This type of treatment, known as dose-fractionated chemotherapy involves giving carboplatin and/or paclitaxel at a lower dose every week during treatment so that a smaller dose of chemotherapy is given every week for 18 weeks rather than a larger dose once every 3 weeks.

Some women will have surgery as the first treatment following their diagnosis then 6 cycles of chemotherapy. Others will have 3 cycles of chemotherapy initially, then surgery followed by 3 more cycles of chemotherapy.

In this study we want to find out if weekly chemotherapy is more effective than standard chemotherapy in treating ovarian cancer. We also want to see if weekly chemotherapy causes more or fewer side-effects than standard chemotherapy. Although weekly chemotherapy involves more doses of chemotherapy than standard chemotherapy, the treatment course is the same length for both.

*Epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer are three types of cancer that affect women. The term “ovarian cancer” is often used to refer to all of them. These cancers are all treated in the same way, which means that women with any of the three can be included in this study.


To participate in ICON8 patients must have met all the following criteria:

  1. Are female and at least 18 years old
  2. Have been diagnosed with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
  3. Have a cancer that is stage IC, II, III or IV (if your cancer is stage IC or IIA, it must be also either a high grade serous cancer, a clear cell cancer or another type that is poorly differentiated)
  4. Are well enough to be up and about for at least half the day
  5. Have satisfactory blood test results
  6. Are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you could become pregnant

To participate in ICON8 patients must not have met all the following criteria:

  1. Have cancer that has spread to your brain or spinal cord
  2. Have a rare type of cancer called mixed Müllerian cancer, ovarian cancer that is not epithelial, certain rare types of peritoneal cancer, or a borderline tumour
  3. Have already had chemotherapy, biological therapy or hormone therapy for ovarian cancer
  4. Have had any other cancer in the last 5 years apart from ductal carcinoma in-situ (DCIS) of the breast, carcinoma in-situ of the cervix or non-melanoma skin cancer that have been successfully treated, or endometrial cancer (a cancer of the womb lining) that was stage IA and low grade
  5. Have ever had radiotherapy to your abdomen or pelvis
  6. Are going to have chemotherapy directly into your abdomen (intraperitoneal chemotherapy)
  7. Have damage to your nerves (peripheral neuropathy)
  8. Are having any other experimental drug
  9. Are known to be sensitive to carboplatin or paclitaxel, or their ingredients
  10. Have any other medical condition that the trial doctors think could affect your taking part
  11. Are pregnant or breastfeeding

Trial design

ICON8 is a phase III trial aiming to recruit about 1,500 women. The study has three different treatment groups. This is a randomised trial and therefore people taking part are assigned to one of the treatment groups by a computer. Neither you nor your doctor will be able to decide which treatment group you will be part of. Women entering the study have an equal chance of receiving any of the three treatments.

The three treatment groups are:

Group 1: Standard chemotherapy in which both carboplatin and paclitaxel are given once every three weeks for total of 18 weeks (also known as 6 cycles)

Group 2 (Research group): Weekly chemotherapy with carboplatin given once every three weeks and paclitaxel once a week (at a lower dose) for a total of 18 weeks.

Group 3 (Research group): Weekly chemotherapy with both carboplatin and paclitaxel given once a week (at a lower dose) for a total of 18 weeks.

All the chemotherapy treatments are given, one at a time, through a drip inserted into a vein, usually on the back of the hand or forearm. The frequency and length of each dose of treatment varies between the treatment groups.

You can enter the trial after having had surgery for your ovarian cancer, in which case you will receive chemotherapy continuously for 18 weeks (6 cycles).

Alternatively, you and your doctors may decide that it would be preferable for you to have chemotherapy before surgery, in which case you may enter the trial and have 3 cycles of chemotherapy followed by surgery and then another 3 cycles of chemotherapy. Surgery is usually performed around 3 to 4 weeks after the start of the third cycle of chemotherapy. To reduce the likelihood of the chemotherapy causing your blood counts to be low before the operation, if you were assigned to treatment groups 2 or 3 (the weekly chemotherapy groups) you would only receive 2 weeks of treatment in the cycle of chemotherapy just before your operation. If your blood counts were low, your doctor would need to delay surgery until they had returned to normal. Your chemotherapy would restart once you and your doctors agree that you had recovered sufficiently from the operation (at least one week after it).

Before starting treatment, at the beginning of each cycle of chemotherapy and at the follow up appointments after you finish treatment, you will be asked to fill out a questionnaire. This questionnaire (Quality of life study) will ask you how you have been feeling and about any side effects you might have had during treatment. These allow us to judge how your quality of life is affected by your chemotherapy treatment.

You will also be asked permission for blood samples to be taken during the trial, and for a sample of the tissue removed when you have (or had) surgery to be made available, for laboratory-based research studies run alongside the clinical part of the study (known as translational research). These samples will be used by researchers to look for substances called biomarkers. These may help in the future to work out which women would benefit most from having weekly chemotherapy. Researchers also want to look for biomarkers that could show that a cancer is starting to grow again before it can be seen on scans. And they want to look at how genes might affect ovarian cancer and how people respond to treatment. You can still take part in the trial if you do not want to give these extra samples for research.

Hospital visits

Women in group 1 will go to hospital once every 3 weeks and women in group 2 or 3 will go to hospital every week for treatment.

If you are entering the trial after having had surgery, this diagram shows a plan of the treatment you could receive on trial, including the number of visits for chemotherapy and the length of each chemotherapy treatment.

If you are entering the trial before having surgery, this diagram shows a plan of the treatment you could receive on trial, including the number of visits for chemotherapy and the length of each chemotherapy treatment.

If you are entering the trial before having surgery, this diagram shows a plan of the treatment you could receive on trial, including the number of visits for chemotherapy and the length of each chemotherapy treatment.

Before you start chemotherapy treatment you will have a:

  1. Physical examination including the assessment of height, weight, pulse rate and blood pressure
  2. Chest X-ray
  3. Heart trace (known as an electrocardiogram)
  4. CT scan or MRI scan

In addition you will have blood tests before each chemotherapy treatment which means that women in group 2 and 3 will have 12 extra blood tests.

You will have a scan after 6 cycles of chemotherapy. If you are having surgery during your chemotherapy treatment, you will also need to have a scan before and after your operation. The first 186 women to take part in the trial will be asked to have an extra scan 9 months after they were assigned to a treatment group.

After you finish treatment you will see the trial team

  1. Every 6 weeks until 9 months after you joined the trial
  2. Then every 3 months until you have been in the trial for 2 years
  3. And every 6 months for 4 years after that

Side effects

Each person’s reaction to chemotherapy drugs is different and the possible side effects of carboplatin and paclitaxel (Taxol) include:

  1. A reduction in white blood cells (neutropenia) which will make you more prone to infection
  2. Bruising or bleeding (such as nosebleeds, bleeding gums or rashes)
  3. Tiredness and breathlessness
  4. Feeling (nausea) or being sick (vomiting)
  5. Loss of appetite or taste changes
  6. Hair loss
  7. Pins and needles or tingling in your hands and feet
  8. Ringing in the ears
  9. Mood swings
  10. Some women have an allergic reaction to either carboplatin or paclitaxel. Before each treatment you will be given steroids and antihistamines to reduce the risk of a reaction.

For further information check the CancerHelp UK ICON8 website on:


Click here for more information about participating in the ICON8 trial


MRC Clinical Trials Unit at UCL
90 High Holborn 

ICON8 and ICON8B: mrcctu.icon8and8b@ucl.ac.uk