Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

adjuvant hypofractionated IMRT for cervical cancer patients

postoperative adjuvant IMRT with hypofractionation (2.5 Gy/fraction, 16 fractions, once a day)

POHIM-RT

Won Park, M.D.,Ph.D

To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.

One group for hypofractionaed IMRT for adjvuant cervical cancer patients

Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer

Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer: A Prospective Exploratory Trial (POHIM_RT Trial)

evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0

evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0

progression free survival rate after the time of surgery

Samsung Medical Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The patients will undergo breast reconstruction with an expander prosthesis.

The patients will undergo lipofilling as a pre-treatment before they will undergo breast reconstruction with an expander prosthesis.

100 ml of autologous fat will be injected to the reconstruction area 3 month prior the breast reconstruction with expander prosthesis.

Autologous fat transplantation

breast reconstruction with expander prosthesis.

Expander prosthesis

Inkeri Schultz, PhD

Åsa Edsander-Nord, Docent

Marie Wickman Chantereau, Professor

The purpose of this study is to determine if autologous fat transplantation as a pre-treatment gives better results in breast reconstruction with implants after mastectomy and radiotherapy. One group is randomized to conventional reconstruction with implant and one to pre-treatment prior reconstruction with implant.

Our aims are:

1. To study whether lipofilling can decrease the number of reoperations and complications such as postoperative infections or not.
2. Evaluate the aesthetic results and the patients' experiences. For both these aims the hypothesis is that pre-treatment is in favour for the outcomes.

All patients will undergo breast reconstruction with expander implant. Half of the patients will be randomized to pre-treatment with lipofilling before the reconstruction. The randomization will be carried out with block randomization. A certain person that has not met the patients has been assigned to do this.

Fat transplantation: The fat will be harvested manually with dry technique using a Coleman cannula on a 10 ml syringe. There after the syringes and fat are centrifuged at 3000 rpm for 3 minutes. Liquid fat from lysed cells and blood will be separated from the purified fat cells and discarded. The fat graft will then be injected fan-shaped in multiple layers into the subcutaneous tissues of the breast using another blunt cannula with a diameter of 1.29 mm. If necessary to obtain a volume of 100 ml fat injected the procedure will be repeated. All sessions will be performed under general anesthesia in day surgery. Three month later the patients will undergo breast reconstruction with expander prosthesis.

Those patients that are randomized to not undergo pre-treatment will undergo breast reconstruction with expander prosthesis immediately.

After the reconstruction all patients will have as many appointments as necessary for expansion with a breast nurse at our clinic. If necessary the patient will also meet the surgeon. After the month the patients have a routine doctors appointment. After 6, 12 and 24 month the patients will be followed up with objective measurements of breast symmetry and they will fill in quality of life formularies. In this study we are using the validated formulary called Breast Q and a study specific formulary. At 24 month standardized photos of the breasts will be taken.

Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?

Does Pre-treatment With Autologous Fat Transplantation Improve Results and Reduce Complication Rate After Breast Reconstruction With Implants? A Randomized Controlled Study

Number of days spent at the hospital for surgery including both day surgery with fat transplantation and reconstruction with prosthesis.

Number of appointments with surgeon and nurse as outpatient after the reconstructive surgery is performed.

Aesthetic outcome is evaluated by plastic surgeons through assessment of standardized photographies of the patients.

Breast Q is a validated questionnaire for quality of life

Karolinska University Hospital

Karolinska Institutet

Adjunct professor

Endometrial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Adjuvant hypofractionated external beam radiotherapy for post operative patients with cervical or endometrial cancer.

External beam radiotherapy to pelvis:

Post operative hypofractionated external beam radiotherapy with intensity modulated/arc technique, to a dose of 39 Gy in 13 fractions, at 3 Gy per fraction, delivered once daily, 5 days a week, over 2.5-3 weeks.

Hypofractionated Image guided External Beam Radiation Therapy (EBRT)

Patients who require adjuvant chemotherapy along with radiation, based on predefined risk features, will receive 5 cycles of cisplatin on a weekly basis with a dose of 40 mg/m2 by IV infusion over a period of 1 hour 2-4 hours prior to start of EBRT.

Vaginal brachytherapy, two fractions of 6 Gy each, delivered 1 week apart.

Vaginal brachytherapy

Dr. Prachi D Mittal, MD

Prachi Mittal, MD

The primary aim of the trial is to investigate the late effects of hypofractionated external radiation (39 Gy in 13 fractions) in patients requiring post-operative radiation for early-stage cervical and endometrial cancers.

This is a phase II prospective study that will be accruing patients with post operative cervical or endometrial cancer requiring adjuvant pelvic radiation.

External beam radiotherapy (Intensity modulated radiotherapy/arc technique) will be delivered to pelvis to a dose of 39 Gray (Gy) in 13 fractions at 3 Gy per fraction, delivered once daily over 2.5 - 3 weeks. Treatment will be delivered with Intensity Modulated Radiotherapy (IMRT) under image guidance. Patients for whom concurrent chemotherapy is indicated (as per adverse risk features) will receive concurrent weekly cisplatin (40mg/m2) based on standard institutional protocol. All patients with post-operative cervical cancer will receive vaginal brachytherapy after the completion of external beam radiation. Patients with endometrial cancer with certain pre defined risk factors will also receive vaginal brachytherapy. The dose of vaginal brachytherapy will be 6 Gy high dose rate brachytherapy delivered as two different fractions, one week apart. Patients will be evaluated by the concerned investigators on a weekly basis during radiation therapy and all the toxicities will be documented according to the CTCAE V 5.0.

Patients will be followed up 3 monthly for the first 2 years, then 6 monthly from years 2 - 5, and annually thereafter. CTCAE version 5 will be used for toxicity grading at each follow-up. Quality of life assessment will be performed at baseline prior to the start of radiation and on follow-up at pre-specified times using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and Cervix - 24 (CX24) for cervical cancer patients and Endometrium 24 (EN24) for endometrial cancer patients.

Single-arm, open-label phase II trial investigating the cumulative incidence of late grade ≥2 gastro-intestinal or genito-urinary toxicities in patients receiving adjuvant hypofractionated external beam radiotherapy to the pelvis for post-operative cervical or endometrial cancer.

Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study

To evaluate the 3-year cumulative incidence of late grade ≥2 gastrointestinal or genitourinary toxicity using CTCAE version 5 scoring receiving radiation with hypo fractionation.

To report 3 year pelvic control rate (local and pelvic nodal) in patients receiving hypofractionated radiotherapy.

To report 3 year disease free survival in patients receiving hypo fractionated radiotherapy.

To report 3 year overall survival in patients receiving hypo fractionated radiotherapy.

Acute toxicity will be reported using CTCAE V. 5.0

To assess quality of life in using EORTC QLQ-C30 and CX24. Quality of life will be measured using the EORTC QLQ C-30. For cervical cancer, EORTC QLQ CX24 module will be used. QOL scoring will be done as per standard recommendations outlined in EORTC QLQ C30 scoring manual. All patients will undergo QOL evaluation at baseline, after treatment and at subsequent follow-up.Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4.

1 will be considered as better outcome \& 4 will be considered as worst outcome.

To assess quality of life in using EORTC QLQ-C30 and EN24. Quality of life will be measured using the EORTC QLQ C-30. For endometrial tumours, EORTC QLQ EN24 will be used. QOL scoring will be done as per standard recommendations outlined in EORTC QLQ C30 scoring manual. All patients will undergo QOL evaluation at baseline, after treatment and at subsequent follow-up.Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4.

1 will be considered as better outcome \& 4 will be considered as worst outcome.

To report cumulative toxicity score as assessed by C-MOSES scoring. Month and Severity Score (MOSES) will be calculated for each symptom (13 gastrointestinal and 6 genitourinary) with time weighted CTCAE toxicity, by using duration of time spent in each toxicity. Cumulative-MOSES score will be assessed for organ system (gastrointestinal and genitourinary), by summating MOSES of individual adverse event items respectively.

Tata Memorial Centre

Assistant Professor

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

patients who has 3 or more minor risk factors of recurrence, and will receive postoperative chemoradiation.

postoperative radiotherapy, 60-66 Gy/30-33 fractions, concurrently with triweekly chemotherapy by Cisplatin

Radiotherapy

Kang-Hsing Fan, MD

The purpose of this study is to determine the treatment outcome of postoperative concurrent chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.

Currently, postoperative chemoradiation is recommended for head and neck squamous cell carcinoma with some poor prognostic feature, such as extracapsular spread of metastatic lymph node, or positive resection margin. Other patients may receive postoperative radiotherapy only, if they have other risk factors. In our previous study, if there are 3 or more "minor" risk factors, the 3-year recurrence rate was 55%. This outcome was far inferior to patients who had minor risk factors less than 3. Thus, we believe that current postoperative radiotherapy is insufficient for patients with multiple minor risks. A clinical trial should be raised to help these patients. However, the patient number of this group is not enough for large scale, phase 3 trial. So we arranged this phase II trial of postoperative chemoradiation to test and prospectively observe the treatment outcome.

Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk

A Phase II Trial of Postoperative Concurrent Chemoradiation for Head and Neck Squamous Cell Carcinoma Patients With Multiple Risk Factors of Recurrence

Chang Gung Memorial Hospital

Doctor

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Patients who were randomized to adjuvant radiotherapy following radical prostatectomy

Patients who were randomized to watchful waiting following radical prostatectomy

The radiation therapy will be given in 37 fractions of 1.8 Gy per day, five days per week. The total dose of radiation will be 66.6 Gy.

Adjuvant radiotherapy

Teuvo Tammela, M.D., Ph.D.

The purpose of this study is to determine whether adjuvant radiotherapy following radical prostatectomy in prostate cancer patients with positive margins or capsular penetration improves biochemical, overall and/or cancer specific survival and whether adjuvant radiotherapy is reasonably well tolerated when compared to watchful waiting.

In this study the investigators will evaluate adjuvant radiation therapy vs. watchful waiting in prostate cancer patients with positive margins or capsular penetration after radical prostatectomy. This is a randomized, open label, multicentre, collaborative study of FinnProstate Group and Finnish Radiation Oncology group.

Adjuvant Radiation Therapy vs. Watchful Waiting Following Radical Prostatectomy in High Risk Prostate Cancer

Adjuvant Radiation Therapy vs. Watchful Waiting in Prostate Cancer Patients With Positive Margins or Capsular Penetration After Radical Prostatectomy

Helsinki University Central Hospital

M.D., Ph.D., Professor of Surgery

postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)

POHIM-CCRT

To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by concurrent chemotherapy with hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.

Postoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer

Postoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Exploratory Trial (POHIM_CCRT Trial)

Patients will be informed by a doctor randomized to practice shared decision making and use the in-consultation PtDA during the consultation on adjuvant radiotherapy.

Patients will be informed by a doctor randomized to inform about adjuvant radiotherapy according to usual practice.

After having received training in SDM, the doctor will practice SDM supported by an in-consultation PtDA during the consultation with the participant.

Shared decision making supported by an in-consultation patient decision aid

Karina D Steffensen, Professor

Stine R Sondergaard, M.D.

The aim of this project is to elucidate whether the use of shared decision making will influence patient engagement in the decision making process about adjuvant radiotherapy after breast conserving surgery for local breast cancer or early stages of local breast cancer.

The risk of recurrence of breast cancer is lowered by adjuvant medical treatment as well as by radiotherapy (RT). On the other hand, all adjuvant treatments involve a risk of side effects; some are acute and transient while others are long-term. Considering the well-known side effects of irradiation, it seems appropriate to involve patients in the decision on whether to receive irradiation.

In the shared decision making (SDM) process clinicians and patients work together to make appropriate health decisions based on clinical evidence and the patient's informed preferences. A patient decision aid (PtDA) is instrumental in the SDM process.

This study is a multicenter, national trial randomizing doctors to either use or not use SDM and a PtDA when informing the patients about benefits and risks of receiving adjuvant radiotherapy.

It is not expected that significantly less patients will receive radiotherapy as a consequence of SDM. The primary aim of the study is to evaluate whether patient engagement in decision making is affected by SDM and the use of an in-consultation PtDA.

Half the doctors at each center will receive training in SDM. These doctors will practice SDM supported by the in-consultation PtDA during every consultation in this study. The other half of the doctors will continue usual practice of informing the patients.

Shared Decision Making With Breast Cancer Patients

Shared Decision Making With Breast Cancer Patients Offered Adjuvant Radiotherapy

Minimum value: 0. Maximum value: 100. The higher the value the more patient engagement.

Minimum value: 0. Maximum value: 36. The higher the value the more fear of recurrence.

Minimum score: 0. Maximum score: 4. The higher the score the more patient engagement.

Minimum value: 0. Maximum value: 100. The higher the value the more effective decision making.

Minimum value: 0. Maximum value: 100. The higher the value the more regret.

Minimum score: 0. Maximum score: 9. The higher the value the more patient engagement.

Minimum value: 0. Maximum value: 100. The higher the value the more quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Postoperative Hypofractionated Intensity-modulated Radiation Therapy in Cervical Cancer	NCT03239626	Cervix Cancer Radiotherapy, A... Radiotherapy, I... Hypofractionate...	POHIM-RT	20 Years - 70 Years	Samsung Medical Center
Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?	NCT02637635	Breast Neoplasm...	Autologous fat ... Expander prosth...	25 Years - 70 Years	Karolinska Institutet
Postoperative Hypofractionated Radiation in Cervical and Endometrial Tumours: Phase II Study	NCT05857631	Cervical Cancer Endometrial Can...	Hypofractionate... Cisplatin Vaginal brachyt...	18 Years - 80 Years	Tata Memorial Centre
Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?	NCT02637635	Breast Neoplasm...	Autologous fat ... Expander prosth...	25 Years - 70 Years	Karolinska Institutet
Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk	NCT00937612	Head and Neck N... Carcinoma, Squa...	Radiotherapy	18 Years - 70 Years	Chang Gung Memorial Hospital
Adjuvant Radiation Therapy vs. Watchful Waiting Following Radical Prostatectomy in High Risk Prostate Cancer	NCT02668718	Prostatic Neopl...	Adjuvant radiot...	-	Helsinki University Central Hospital
Postoperative Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer	NCT03239613	Cervix Cancer Radiotherapy, A... Radiotherapy, I... Hypofractionate... Chemotherapy, C...	POHIM-CCRT	20 Years - 70 Years	Samsung Medical Center
Shared Decision Making With Breast Cancer Patients	NCT04177628	Shared Decision... Breast Neoplasm... Radiotherapy, A...	Shared decision...	18 Years -	Vejle Hospital
Shared Decision Making With Breast Cancer Patients	NCT04177628	Shared Decision... Breast Neoplasm... Radiotherapy, A...	Shared decision...	18 Years -	Vejle Hospital

Spots Global Cancer Trial Database for radiotherapy, adjuvant