No Placebo-Only Group

Pivotal Trial

This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

Hormone Therapy + Chemotherapy for Breast Cancer

This study is evaluating whether hormone therapy alone or hormone therapy together with chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25.

I am receiving treatment for chronic obstructive pulmonary disease.

I am a woman who can have children and am not using birth control.

I had an Oncotype DX test, but my recurrence score wasn't between 11-25.

My cancer is positive for estrogen and/or progesterone receptors.

I have heart issues that prevent me from using certain cancer drugs.

I have had surgery that meets the trial's requirements.

I haven't had chemotherapy or radiation for my cancer.

My tumor is between 5 mm and 5 cm, possibly with aggressive features.

My doctor and I agree to start standard chemotherapy and hormonal therapy after surgery.

I have a breast cancer tissue sample ready for testing.

I have been cancer-free from any previous cancers for at least 5 years.

Anastrozole

Combination Chemotherapy

Exemestane

Letrozole

Tamoxifen Citrate

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery

Chemotherapy + Bevacizumab for Non-Small Cell Lung Cancer

This study is evaluating whether chemotherapy and bevacizumab are more effective than chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery.

Your SGPT (ALT) level in the blood is less than 5 times the upper limit of normal.

I had surgery to remove my lung cancer, which was not a minor procedure, and had specific lymph nodes checked.

Your total bilirubin level must be less than or equal to 1.5 mg/dL.

I haven't had hormone or radiation cancer treatments in the last 5 years.

Your prothrombin time/international normalized ratio (INR) should be 1.5 or less.

My blood clotting time is within the normal range, or if I'm on blood thinners, it's not more than 1.5 times the upper limit.

I am not currently coughing up a significant amount of bright red blood.

I have had heart issues but have been symptom-free for over a year.

You must have a certain amount of a type of white blood cell called neutrophils in your blood.

Women who could become pregnant must take a blood or urine test to make sure they are not pregnant before joining the study.

I haven't had any cancer in the last 5 years, except for cervical in-situ carcinoma or non-melanoma skin cancer that was fully removed.

My blood pressure is under control and below 150/90.

I am on a stable blood thinner regimen or using it for DVT prevention.

I am taking aspirin or NSAIDs daily, but not dipyridamole, ticlopine, clopidogrel, or cilostazol.

I am eligible for pemetrexed/cisplatin therapy.

My lung cancer is not of the squamous cell type.

My kidney function is good, as shown by recent tests.

My blood clotting time is within safe limits while on blood thinners.

Your SGOT (AST) levels are not more than 5 times the upper limit of normal.

I had lung surgery between 6 to 12 weeks ago and have recovered well.

Your kidney function, as measured by a blood test for creatinine, is within a certain range.

I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last month.

I am not expecting to undergo any major surgeries during the study.

I am fully active or restricted in physically strenuous activity but can do light work.

I have never had a stroke or a mini-stroke.

My urine protein levels are low enough for me to join.

I have never had chemotherapy, except possibly low-dose methotrexate for a non-cancer condition.

I haven't had major surgery, serious injuries, or biopsies recently.

I don't have any serious infections, heart issues, or other conditions that would stop me from following the study's requirements.

You are allergic to Chinese hamster ovary cell products or other similar medicines made from living cells.

Your platelet count must be at least 100,000 per cubic millimeter.

Bevacizumab

Cisplatin

Docetaxel

Gemcitabine Hydrochloride

Pemetrexed Disodium

Questionnaire Administration

Vinorelbine Tartrate

This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.

Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

Chemotherapy + Radiation + Bevacizumab for Lung Cancer

This study is evaluating whether a combination of chemotherapy, radiation therapy, and bevacizumab is more effective than chemotherapy, radiation therapy, and bevacizumab alone in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.

I do not have a serious heart rhythm problem that needs medication.

You need to have a negative pregnancy test.

I have no cancer history except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 5 years.

I do not have serious blood vessel problems in my arms or legs.

Your disease can be seen on a CT scan or MRI.

My condition cannot be treated with surgery.

My lung cancer is confirmed to be non-small cell type.

I haven't had a heart attack or unstable chest pain in the last 6 months.

It has been over a week since my last biopsy or mediastinoscopy.

I've had surgery to diagnose or stage my lung cancer.

I have not had a stroke in the last 6 months.

My cancer has not spread to the opposite chest, liver, or adrenals.

I have a small amount of fluid in my chest, only seen on scans.

My lung cancer is non-squamous and considered low risk.

My lung cancer is considered high-risk based on its type and test results.

I will use birth control during and for 6 months after my last bevacizumab dose.

My cancer is at stage IIIB with specific conditions.

I am not currently undergoing intensity-modulated radiotherapy.

You do not have cancer that has spread to your brain.

I do not have any serious wounds, ulcers, or broken bones that are not healing.

I have not had cancer before, except for certain types.

I have not had surgery to remove my condition.

I am not currently receiving any specialized radiation treatments.

I am not receiving preventive radiation therapy to lymph nodes near my collarbone or opposite lung.

My lung can handle the planned radiation dose without too much damage.

I am not receiving any other cancer treatments right now.

I have not had chemotherapy or radiotherapy for lung cancer.

My cancer stage fits one of the trial's required stages.

It's been over 4 weeks since my last major surgery and I have recovered.

If you have fluid around your lungs or in your abdomen, or if certain lab tests are the only way to tell if you have the disease, you can't participate.

I do not have severe numbness or pain in my hands or feet.

There are no signs of air-filled spaces in the lungs.

My kidney, lung function, blood counts, and clotting ability are normal.

I have not had radiation therapy to my neck or chest.

My cancer is at stage IIIA with specific N2 lymph node involvement.

I don't have any conditions besides lung cancer that increase my risk of bleeding.

My heart functions well without severe symptoms.

I am not on any full-dose blood thinners.

I do not have any bleeding or clotting disorders.

I am not undergoing any major surgeries right now.

You are not allergic to Chinese hamster ovary cell products or other genetically engineered human antibodies.

Etoposide

Radiation Therapy

This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.

Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer

Radiation Therapy + Cisplatin for Endometrial Cancer

This study is evaluating whether radiation therapy and cisplatin are more effective than radiation therapy alone in treating patients with endometrial cancer.

I have not had serious heart problems in the last 6 months.

My nerve damage does not significantly affect my daily activities.

I have had a stent or tube placed for my blocked ureter before joining the study.

I have not had any cancer other than non-melanoma skin cancer in the past 5 years.

My cancer has spread outside the pelvis, including to lymph nodes.

I can take care of myself but might not be able to do heavy physical work.

You are expected to live for at least 3 months.

Your blood tests must show specific levels as per CTCAE v 3.0.

My condition limits me to only taking care of myself or I am completely disabled.

I have been diagnosed with a type of endometrial carcinoma.

I have not had extensive surgery, but I am eligible if all visible cancer was removed.

I had surgery to remove a returning tumor and scans show no remaining cancer.

I have a unique kidney shape or a kidney transplant affecting radiation treatment.

I have received chemotherapy for my current cancer recurrence.

I have had radiation therapy in the vaginal, pelvic, or abdominal area.

My endometrial cancer has returned in my pelvis or vagina, with no spread outside the pelvis.

You have a history of ongoing collagen vascular disease.

I had surgery to remove my uterus, ovaries, and fallopian tubes for uterine cancer.

My cancer has not spread beyond the pelvic area.

I have had surgery to remove a significant amount of cancer from my pelvis or vagina.

I finished hormone or chemotherapy over 6 months ago and my cancer has returned since then.

3-Dimensional Conformal Radiation Therapy

Intensity-Modulated Radiation Therapy

Internal Radiation Therapy

RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.

Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

Surgical Procedures for Early-Stage Lung Cancer

This study is evaluating whether wedge resection or segmentectomy is better than lobectomy for treating stage IA non-small cell lung cancer.

My lung scans show ground glass opacities or I have N1 or N2 lung cancer.

Your doctor hasn't confirmed that there is no cancer spread using a quick frozen tissue test.

My right-sided tumor's nodes 4, 7, and 10 were not confirmed negative.

I can take care of myself and am up and about more than half of the day.

I haven't had cancer, except for certain skin, bladder, or cervical cancers, in the last 3 years.

My left-sided tumor's lymph nodes at levels 5, 6, 7, and 10 were not confirmed negative.

My lung nodule is 2 cm or smaller, located on the outer part of my lung, and presumed to be cancer.

Lymph nodes that were confirmed to have cancer during a quick frozen section test.

My cancer has not spread beyond its original location.

You have not had a biopsy to confirm that you have non-small cell lung cancer.

Lobectomy

Segmentectomy

Wedge Resection

This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride when given together with or without bevacizumab after surgery to see how well it works in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.

Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Chemotherapy +/− Bevacizumab for Ovarian Cancer

This study is evaluating whether a combination of chemotherapy and bevacizumab is more effective than chemotherapy alone in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.

I will start treatment with bevacizumab in my second cycle after surgery to reduce my tumor.

My cancer is of a specific type affecting the lining of organs.

My cancer responded completely to my initial platinum-taxane therapy.

I am currently receiving immunotherapy or radiotherapy.

I have not had radiation therapy to my abdomen or pelvis.

I have not had surgery to remove cancer that came back.

My previous cancer diagnosis fits the trial's requirements.

I have an infection that is not responding to treatment.

I haven't had cancer treatment for 6 months and my cancer hasn't worsened.

I am receiving or have received initial treatment that includes maintenance therapy after a complete response.

I have not had chemotherapy for any abdominal or pelvic tumor except for ovarian, fallopian tube, or primary peritoneal cancer.

I have moderate to severe numbness, tingling, or pain in my hands or feet.

I am not pregnant, nursing, or able to become pregnant without using effective birth control.

I do not have any conditions that cause serious bleeding.

I have not had major surgery, dental surgery, or significant injury recently.

I am having surgery not aimed at reducing my cancer before starting treatment.

My cancer responded completely to initial chemotherapy, with normal exams and CA125 levels.

I agree to let a random selection decide my surgery type.

I had an allergic reaction to chemotherapy but was successfully treated with a desensitization program.

My cancer has come back and can be observed.

Your disease must have at least one measurable lesion that can be accurately measured.

I do not have a history or signs of specific brain or spinal cord diseases.

I do not have any major heart conditions.

My ovarian, peritoneal, or fallopian tube cancer has come back.

Patients need to have specific blood and body chemistry levels.

I have had only one chemotherapy regimen for my condition.

I need IV fluids or nutrition due to partial bowel blockage or a tear.

I haven't had any cancer besides non-melanoma skin cancer in the last 5 years.

Carboplatin

Paclitaxel

This randomized phase III trial studies radiation therapy to see how well it works with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.

Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

Radiation Therapy + Trastuzumab for Breast Cancer

This study is evaluating whether radiation therapy is more effective with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy.

I have been cancer-free for over 5 years and at low risk of it coming back.

I have suspicious masses or calcifications that have not been biopsied.

My blood pressure is not controlled by medication.

My breast cancer is invasive, even if it's very small.

My DCIS is HER2-positive based on specialized testing.

I have received whole breast radiation before being considered for this study.

My surgery removed all the cancerous cells.

UC Irvine Clinical Trials 2022

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