Clinical trial: NCT00981656
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study? (3/31/14)|What Other Choices Do I Have If I Do Not Take Part In This Study? (3/31/14)(3/6/2015)

Taking part in this study may or may not make your health better. While researchers hope that radiation plus chemotherapy will remove all the cancer in your bladder so that surgical removal of the bladder itself (cystectomy) is not necessary, there is no guarantee that a cystectomy will not need to be done.  
One of the risks of undergoing the radiation plus chemotherapy in this study is that if a cystectomy is needed, the radiation plus chemotherapy might make the surgery more difficult and make it less likely that the surgeon would judge it safely possible to carry out all aspects of the procedure without needing to create a permanent opening in the abdomen (a type of "urinary diversion" procedure).  
We do know that information from this study will help us learn more about the advantages of the treatment used in the study and will help researchers learn more about the use of radiation and chemotherapy for patients with this type of bladder cancer. This information could help future cancer patients who have non-muscle invading bladder cancer.

Your other choices may include:
- Removal of the bladder (radical cystectomy) and a urinary diversion procedure. This is the standard approach for patients with non-muscle invading tumor or tumors with at least one being Stage T1 who have failed BCG therapy within 18 months of this treatment with a Ta or a T1 tumor and those patients who may have failed other forms of injection of drugs into their bladder, or patients who were initially diagnosed with a T1 tumor but who were unsuited to receive BCG therapy.  
- Newer forms of intravesical (within the bladder) chemotherapy with previously untested and non standard drugs as part of another study
- Radiation therapy alone
- Receiving no additional treatment other than repeat transurethral resections (with this choice, your tumor could continue to grow and your disease could spread)
Talk to your study doctor about your choices before you decide if you will take part in this study.
Clinical trial: NCT00981656
Section: Confidentiality
Subsections: Will My Medical Information Be Kept Private? (4/6/12) (3/31/14)

Data are housed at NRG Oncology Statistics and Data Management Center in a password-protected database. We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.  
Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:
- NRG Oncology - The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for people A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.  
[Note to Informed Consent Authors: the above paragraph complies with the new FDA regulation found at 21 CFR 50.25(c) and must be included verbatim in all informed consent documents. The text in this paragraph cannot be revised.]
Clinical trial: NCT00981656
Section: Duration of Study Involvement
Subsections: How Long Will I Be In The Study? (4/20/15)

Radiotherapy and chemotherapy will begin within 15 weeks after the transurethral bladder resection and will take 6 to 8 weeks to complete.  
Eight to 10 weeks after the completion of the radiation and chemotherapy, the study doctor will reexamine your bladder. If your tumor has completely disappeared, you will be seen during follow-up visits every 3 months after completion of treatment for the first year, every 4 months during the 2nd year, every 6 months for years 3, 4, and 5, then once a year thereafter. If your tumor has not completely disappeared or if it comes back (recurrence) and you are medically fit for surgery, surgical removal of your bladder will be recommended at this time.
Clinical trial: NCT00981656
Section: Participant's Rights
Subsections: What Are My Rights If I Take Part In This Study? (3/6/2015)

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits.  
Leaving the study will not affect your medical care. You can still get your medical care from our institution. We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study.  
A Data Safety Monitoring Board will be regularly meeting to monitor safety and other data related to phase I, I/II, and II NRG Oncology clinical trials. The Board members may receive confidential patient information, but they will not receive your name or other information that would allow them to identify you by name. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.
Clinical trial: NCT00981656
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can I Expect From Being In The Study? (4/6/12)(3/6/2015)|Rare, And Serious In 100 People Receiving Pelvis Radiation, 3 Or Fewer May Have:|Common, Some May Be Serious|Common, Some May Be Serious|Rare, And Serious|Common, Some May Be Serious|Common, Some May Be Serious|Risks Of Surgery: If Removal Of Your Bladder Is Necessary|What Happens If I Am Injured Because I Took Part In This Study?|Risks

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, researchers don't know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects.  
Many side effects go away soon after you stop radiation and chemotherapy. In some cases, side effects can be serious, long lasting, or may never go away.  
You should talk to your study doctor about any side effects that you have while taking part in the study.  
Risks and side effects related to the radiation therapy to the pelvis in this study **include those** which are:
COMMON, SOME MAY BE SERIOUS
In 100 people receiving pelvis radiation, more than 20 and up to 100 may have:
- Hair loss in the treatment area, may be permanent
- Diarrhea - Need to urinate often
- Urgency with urination
- Slower urinary flow
- Tiredness
- Pain, including with urination and/or bowel movements - Nausea, vomiting
- Painful sexual intercourse (women)
- Abnormal sexual function, may be permanent (men)  
In 100 people receiving pelvis radiation, from 4 to 20 may have:
- Chronic bowel/bladder symptoms as described above - Blood in urine
- Inability to control urine, inability to control bowel movements
- Mucous-like stools - Bleeding of the rectum - Swelling, redness, rash, skin changes, or itching in the area of radiation

- Weight loss
- Blockage of internal organs that may require surgery
- A tear or hole in internal organs that may require surgery
- Bladder shrinkage, discomfort, or bleeding which may require medication or surgery, including removal of the bladder.  
- Internal bleeding which may cause bleeding of the rectum, black tarry stool, blood in vomit, blood in urine, and may require surgery.  
- Infection which may cause painful and frequent urination
- A new cancer resulting from treatment of earlier cancer Radiation to the pelvis will cause sterility (inability to father children or become pregnant).  
 Women of childbearing potential will go through menopause and may require the use of hormones given orally to replace the hormones normally produced by the ovaries.

In 100 people receiving Cisplatin, more than 20 and up to 100 may have:
- Nausea, vomiting
- Infection, especially when white blood cell count is low
- Anemia which may cause tiredness, or may require blood transfusions
- Bruising, bleeding
- Kidney damage which may cause swelling, may require dialysis - Hearing loss including ringing in ears  
In 100 people receiving Cisplatin, from 4 to 20 may have:
- Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of breath, swelling of the face or throat
- Confusion
- Difficulty with balance

In 100 people receiving 5-Fluorouracil, more than 20 and up to 100 may have:
- Hair loss
- Redness, pain or peeling of palms and soles - Rash, increased risk of sunburn, itching - Diarrhea, nausea, vomiting, loss of appetite
- Difficulty swallowing
- Sores in mouth
- Heartburn
- Headache  
In 100 people receiving 5-Fluorouracil, from 4 to 20 may have:
- Chest pain
- Blood clot
- Belly pain
- Internal bleeding which may cause black tarry stools
- Infection, especially when white blood cell count is low
- Anemia which may require blood transfusions - Cough, hoarseness
- Bruising, bleeding
- Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of breath, swelling of the face or throat
- Confusion
- Abnormal eye movement, blurred vision, watering eyes
- Discomfort from light  
In 100 people receiving 5-Fluorouracil, from 4 to 20 may have:
- Swelling, redness, tingling and pain of hands and feet
- Difficulty with balancing RARE, AND SERIOUS
In 100 people receiving 5-Fluorouracil, 3 or fewer may have:
- Damage to the heart which may cause shortness of breath
- A new cancer resulting from treatment of earlier cancer Possible Side Effects of Mitomycin (Table Version Date: May 28, 2013)
COMMON, SOME MAY BE SERIOUS
In 100 people receiving Mitomycin, more than 20 and up to 100 may have:
- Infection, particularly when white blood cell counts are low
- Anemia which might require blood transfusion
- Tiredness
- Nausea, vomiting, diarrhea
- Swelling of the body
- Difficult, painful or frequent urination (when the drug is administered into the bladder)
OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving Mitomycin, from 4 to 20 may have:
- Loss of appetite
- Sores in the mouth
- Rash
- Hair loss - Loss of fertility RARE, AND SERIOUS
In 100 people receiving Mitomycin, 3 or fewer may have:
- Scarring of the lungs
- Kidney failure that could require treatment with dialysis

In 100 people receiving Cisplatin, 3 or fewer may have:
- Cancer of bone marrow caused by chemotherapy later in life
- Seizure Possible Side Effects of 5-Fluorouracil (Table Version Date: October 24, 2013)

In 100 people receiving Cisplatin, more than 20 and up to 100 may have:
- Nausea, vomiting
- Infection, especially when white blood cell count is low
- Anemia which may cause tiredness, or may require blood transfusions
- Bruising, bleeding
- Kidney damage which may cause swelling, may require dialysis - Hearing loss including ringing in ears  
In 100 people receiving Cisplatin, from 4 to 20 may have:
- Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of breath, swelling of the face or throat
- Confusion
- Difficulty with balance

In 100 people receiving 5-Fluorouracil, more than 20 and up to 100 may have:
- Hair loss
- Redness, pain or peeling of palms and soles - Rash, increased risk of sunburn, itching - Diarrhea, nausea, vomiting, loss of appetite
- Difficulty swallowing
- Sores in mouth
- Heartburn
- Headache  
In 100 people receiving 5-Fluorouracil, from 4 to 20 may have:
- Chest pain
- Blood clot
- Belly pain
- Internal bleeding which may cause black tarry stools
- Infection, especially when white blood cell count is low
- Anemia which may require blood transfusions - Cough, hoarseness
- Bruising, bleeding
- Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of breath, swelling of the face or throat
- Confusion
- Abnormal eye movement, blurred vision, watering eyes
- Discomfort from light  
In 100 people receiving 5-Fluorouracil, from 4 to 20 may have:
- Swelling, redness, tingling and pain of hands and feet
- Difficulty with balancing RARE, AND SERIOUS
In 100 people receiving 5-Fluorouracil, 3 or fewer may have:
- Damage to the heart which may cause shortness of breath
- A new cancer resulting from treatment of earlier cancer Possible Side Effects of Mitomycin (Table Version Date: May 28, 2013)
COMMON, SOME MAY BE SERIOUS
In 100 people receiving Mitomycin, more than 20 and up to 100 may have:
- Infection, particularly when white blood cell counts are low
- Anemia which might require blood transfusion
- Tiredness
- Nausea, vomiting, diarrhea
- Swelling of the body
- Difficult, painful or frequent urination (when the drug is administered into the bladder)
OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving Mitomycin, from 4 to 20 may have:
- Loss of appetite
- Sores in the mouth
- Rash
- Hair loss - Loss of fertility RARE, AND SERIOUS
In 100 people receiving Mitomycin, 3 or fewer may have:
- Scarring of the lungs
- Kidney failure that could require treatment with dialysis

In men, after radiation, the operation generally includes removal of the bladder, the pelvic lymph nodes, the seminal vesicles, and the prostate. As a result, there is likely to be loss of sexual function. In women, the operation may include removal of the bladder, vagina, uterus, tubes, and ovaries. As a result, women may not be able to have children and may find intercourse difficult. Also during surgery, a urinary diversion procedure is necessary; this probably will include placement of a permanent opening (stoma)
created in the abdomen and a bag placed over it to collect the urine. In some circumstances other types of urinary diversion may be possible, based on the judgment of your surgeon.  
In general, there is a higher risk of complications for you when surgery follows radiation and chemotherapy. Surgery and bladder reconstruction can be more difficult and the choices for bladder reconstruction are limited. In addition, if chemotherapy fails to decrease the size of the tumor, your cancer can be more advanced at the time of surgery.  
After bladder removal, the major complications that can occur include infection, heart attack, stroke, severe bleeding, blood clots in the legs or the lung and injury to the rectum or other areas of the intestine. This type of injury may require a second temporary stoma to allow the intestine to heal. Injury to the intestine may also lead to abnormal connections (fistulas) between the intestines and other organs.  
Minor complications include wound infection and delayed hospital stay due to intestinal inactivity (ileus).  
Reproductive Risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Radiation to the pelvis will cause sterility (inability to father children or become pregnant). Women of childbearing potential will go through menopause and may require the use of hormones given orally to replace the hormones normally produced by the ovaries.  
For more information about risks and side effects, ask your study doctor.

It is important that you tell your study doctor, __________________ *[investigator's name(s)],* if you feel that you have been injured because of taking part in this study. You can tell the study doctor in person or call him/her at __________________ *[telephone number].* You will get medical treatment if you are injured as a result of taking part in this study. You and/or your health plan will be charged for this treatment. The study will not pay for medical treatment.

The greatest risk to you is the release of information from your health records. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is very small.
Clinical trial: NCT00981656
Section: Procedures
Subsections: What Will Happen If I Take Part In This Research Study? (4/6/12)(5/15/12)

If you take part in this study, you will have a surgical procedure called a transurethral bladder resection.  
Under sedation (anesthesia), a lighted tube (fiberoptic scope) is inserted through the urethra (the small tube-like structure that allows urine to empty from the bladder) into the bladder. The surgeon examines your bladder tumor through this fiberoptic scope. The surgeon then will remove your tumor as thoroughly as is safely possible using an electric current. Some of your tissue around the tumor also will be removed (biopsy).
Clinical trial: NCT00981656
Section: Purpose of Research
Subsections: Why Is This Study Being Done? (3/31/14)(3/6/2015)

For patients with your type of bladder cancer (non-muscle invading tumor or tumors with at least one being a Stage T1 tumor) for whom standard treatment (such as BCG therapy) was not successful or for whom BCG treatment is judged unsuitable, the usual next step for treatment in patients that are medically fit and accept this treatment is removal of the bladder (cystectomy). However, recently there have been reports that indicate a good success rate in destroying your type of bladder cancer using a repeat surgical procedure (transurethral resection of the bladder tumor) followed by radiation therapy plus chemotherapy.  
The majority of patients receiving this treatment did not require cystectomy and were able to maintain very satisfactory bladder function.  
The purpose of this study is to find out the effects of transurethral surgery followed by radiation therapy plus chemotherapy. Although the combination of radiation therapy and chemotherapy used in this study is not an experimental treatment because it is used for patients with more advanced bladder cancer (the type that has invaded the bladder muscle), the use of this approach in this study is new for patients like you with either a tumor initially presenting as a non-muscle invading stage T1 tumor that has recurred within 18 months of receiving BCG therapy or with a stage Ta tumor treated by BCG therapy but recurred within 18 months as a T1 tumor.
Clinical trial: NCT00981656
Section: Withdrawal from Study
Subsections: Can I Stop Being In The Study?

Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely.  
It is important to tell the study doctor if you are thinking about stopping so any risks from the radiation and chemotherapy (cisplatin) can be evaluated by him/her. Another reason to tell your study doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you.  
The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.