Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Herbal and Botanical

All Drugs and Chemicals

Kava

Pelvic lymphadenectomy dissection began at the origin of the external iliac vessels and continued caudally along the medial border of the psoas muscle, with the lower limit of the external iliac lymphadenectomy being represented by the deep inferior epigastric vessels. The lateral boundaries of lymphadenectomy were delineated superficially by the fascia covering the psoas muscle and deeply by the fascia covering the internal obturator and levator ani muscles. Lymph nodes along the external iliac vessels were removed en bloc with those adjacent to the common iliac vessels. Aortic lymphadenectomy dissection began at the aortic bifurcation by removing the superficial intercavoaortic, precaval, and preaortic nodal groups. Lymph nodes located lateral to the vena (i.e., paracaval nodal group) were separated from the vena cava, then removed en bloc. Lymph nodes behind the vena cava are removed if enlarged. Removal of the lateroaortic nodes was performed up to the level of the left renal vein.

Systematic pelvic and aortic lymphadenectomy

Catholic University of Sacred Heart

Fagotti Anna, MD, PhD

Fanfani Francesco, MD

Costantini Barbara, MD

Vizzielli Giuseppe, MD

Perelli Federica, MD

The purpose of this study is to determine the role of lymphadenectomy in advenced ovarian cancer patients at the time of interval debulking surgery after neoadjuvant chemiotherapy.

Moreover it is a prospective trial, aimed to investigate the prognostic role of sistematic lymphadenectomy in terms of percentage of micrometastases detected, morbidity (complications rate), progression free interval, overall survival, recurrence pattern.

In patients with advanced ovarian cancer (FIGO stage III-IV), a percentage between 50% and 80% had lymph node metastases at diagnosis, mainly in para-aorto-caval (48 %) and iliac areas (49%). In 1988, FIGO has included lymph node metastasis in stage IIIC, although some authors argue that only node involvement constitutes a clinical course different from IIIC cancer patients with abdominal diffusion.

Although it has been demonstrated that lymphadenectomy is technically feasible and relatively safe in this subset of patients, however, it is burdened by a certain percentage of complications including limphocyst, lymphedema, hemorrhage, ranging from 6% to 45%. In addition, the actual therapeutic role is still controversial and it is not clear whether this surgical procedure should be part of the staging of these tumors. Retrospective studies have shown a benefit on overall survival in patients with ovarian cancer who underwent lymphadenectomy associated with optimal debulking (residual tumor \<1 cm). In a recent publication by SEER is found that the number of lymph nodes removed during surgery for advanced ovarian cancer is an independent prognostic factor.

In the literature there is only one prospective randomized study on lymphadenectomy in advanced ovarian cancer without node lesions macroscopically observed (bulky nodes) during the first surgery. The authors reported a significant benefit in terms of disease free survival (DFS), but not in terms of overall survival (OS) in patients who underwent systematic lymphadenectomy and who had a residual tumor \<1 cm. Patients with intra-abdominal residual tumor \<1 cm could theoretically not benefit from a systematic lymphadenectomy since most of lymph node metastases undetectable to intraoperative assessment are smaller than 1 cm.

About 20% of ovarian cancer patients stage III-IV, however, are not operable at the time of diagnosis because of the spread of the disease. In these cases, the gold standard treatment consists of submitting the patient to Interval Debulking Surgery (IDS) after neoadjuvant chemotherapy. The prognosis of these patients compared to those who are subjected to primary surgery, with the same residual tumor after surgery, is currently a topic of controversial debate. Recently, a multicenter, randomized EORTC showed no difference in prognosis between primary surgery and Interval Debulking Surgery in a population stratified by residual tumor. There are few retrospective studies that consider the presence of lymph node metastases in patients undergoing Interval Debulking Surgery: the percentage of lymph node metastases in this subset varies from 37.5% to 75%.

The purpose of the study is to assess whether systematic pelvic and aortic lymphadenectomy should be part of standard surgical procedures in patients with ovarian cancer who underwent surgery after neoadjuvant chemotherapy with intra-abdominal residual tumor \<1 cm.

All patients candidate for Interval Debulking Surgery which do not present bulky nodes at surgery and which have an intra-abdominal residual tumor \<1 cm at the end of the surgery will be enrolled in the study.

The baseline assessment of patients is to perform general blood tests, CA 125, CT thorax, abdomen, pelvis, anesthetic assessment and, if eligible, the patients will be subjected to the treatment above.

The enrollment period will last for 2 years until the achieving of 65 patients as the study population. The median follow-up of 6 months for all patients for the primary objectives and a median of 36 months for the secondary objectives.

LYmphadenectomy After NeoAdjuvant Chemotherapy

Lymphadenectomy After Neo-Adjuvant Chemotherapy in Ovarian Neoplasm

Catholic University of the Sacred Heart

Professor Giovanni Scambia

Uterine Cervical Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Cisplatin

Tubulin Modulators

Antimitotic Agents

3 cycles of neoadjuvant chemotherapy (NACT) (Inj.Paclitaxel +Inj.Carboplatin) followed by surgery (radical abdominal hysterectomy Class III , bilateral pelvic lymphadenectomy \& lower para aortic lymph node sampling)

Radiation therapy will be administered to whole pelvis followed by intracavitary brachytherapy. Patients will be given chemotherapy (Inj.Cisplatin) concurrently with external beam radiotherapy.

NACT

Radical abdominal hysterectomy (class III), BPLND & lower para aortic lymph node sampling

Inj.Cisplatin

Radiation therapy will be administered to the whole pelvis region followed by intracavitary brachytherapy.

Concurrent chemo radiotherapy

Sudeep Gupta, MD, DM

Shyam K Shrivastava, MD

Carcinoma cervix is a common malignancy in women in developing countries including India. The standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these patients. However NACT-Surgery approach has never been compared to the current standard of concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3 courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to IIB squamous cell carcinoma of the uterine cervix.

Cancer of the uterine cervix is a major health problem in the developing countries including India and is the commonest cancer amongst women in India with nearly 1,00000 new women diagnosed to have this cancer every year. It is also the main cause of cancer related mortality among women in India. At the Tata Memorial Hospital, approximately 1600 new patients with cervical cancer are registered every year, of which nearly 70% present in locally advanced stages.

A majority of patients diagnosed with stage IB cervical cancer in India have bulky tumours (more than 4 cm in size) and have now been classified as stage IB2 as per the new FIGO staging (1). These tumours are associated with a high incidence of pelvic lymph node metastases. Finan et al (2) noted positive pelvic nodes in 15.5% of patients with stage Ib1 disease versus 43.8% with stage Ib2. Positive paraaortic nodes were present in 1.8% of patients for stage Ib1 disease versus 6.3% of patients with stage Ib2. The result of radical surgery and radical radiation therapy alone or in combination in these tumours has been reported to be much inferior to stage IB1 tumours (60-65% vs. 85-90% five year survival). The incidence of pelvic lymph node metastasis and the results of treatment of stage IB2 tumours are more or less similar to those with stage IIB tumours.

The ability of radiotherapy or surgery to cure locally advanced cervical cancer is limited by the size of the tumour, high incidence of pelvic lymph node metastases and potential for systemic spread. Besides, the doses required to treat large tumours exceed the limit of toxicity in normal tissue. Efforts to overcome this problem have included the use of different chemotherapy drugs in different schedules. Chemotherapy has been used in the management of locally advanced cervical cancers along with radiation therapy and surgery in different ways e.g. neoadjuvant, adjuvant and concurrent.

The standard approach to using chemotherapy in the treatment of patients with locally advanced disease is the use of concurrent chemoradiation. The concurrent use of single drug and multiple drug regimens with radiotherapy has been tested in women with cervical cancer. Recent data from prospective randomised trials and two meta-analyses (3-12) has unequivocally shown significant survival advantage (both disease free and overall survival) with the use of concurrent chemoradiation using platinum based chemotherapy compared to radical radiation alone in patients with locally advanced cervical cancer (stages IB2-IIIB). A significant reduction in distant metastases was also noted in the concurrent chemoradiation therapy arm. This has led to acceptance of concurrent chemoradiation therapy as the new standard of care for locally advanced cervical cancer. The meta-analyses of these trials showed that the beneficial effect on survival was more evident in stage IB2 and stage II B tumours compared to stage III B tumours (which constituted only about 35% of total number of patients).

An alternative approach is to use chemotherapy prior to local therapy, which could be surgery or radiation. Some theoretical benefits of neoadjuvant chemotherapy (hereinafter abbreviated as NACT) like eradication of micrometastases have long been advanced but never proven. It certainly helps in the reduction of tumour bulk in some patients with locally advanced disease. Some of these latter patients are then able to undergo surgery which is otherwise not possible. The downside to NACT is the delay in institution of definitive treatment in the 20 to 30% patients who don't respond to chemotherapy. The randomized trials of NACT followed by radiation therapy versus radiation therapy alone showed no improvement in survival (13-19). It is possible that the failure to show a survival benefit with NACT followed by radiation is due to the selection of chemoresistant clones which are also radioresistant. A second explanation (also advanced for the failure of NACT approach in head and neck cancers) is that NACT just selects out the patients (the ones who respond) who have biologically favourable disease and confers no benefit by itself. Surgical removal of the tumour after chemotherapy will however have no interaction with biochemical resistance of the remaining clones. It therefore has the potential of providing a benefit additive to chemotherapy and radiotherapy. In their papers Sardi et al (20, 21) reported on their randomized trial of NACT (bleomycin, vincristine and cisplatin) followed by surgery plus radiation versus either surgery plus radiation or radiation as the control arm in patients with stage 1B, 2B and 3B cervical cancer. There was a high response rate to NACT in stage 1B patients (90% in 1B1 and 83.6% in 1B2). The overall survival in the whole group of stage 1B patients was superior in the NACT arm (n=102) compared to the control arm (n=103) (81% Vs 66%, p = 0.025). The resectability rate among stage 1B2 patients given NACT was 100% (n = 61) compared to 85% in the controls (n = 56). In stage 2B the resectability rate in the NACT arm was 80% (n = 76) compared to 56% in the control arm (n = 75). However there was no clear survival advantage of the NACT arm over controls in stages 2B and 3B. Although this trial has reported a survival advantage of NACT followed by surgery in a subgroup of patients its results are not definitive. The treatment offered in the control arm of this trial (attempt at surgical removal upfront in stages 1B and 2B or radiation only in stages 2B and 3B) was not standard by current standard and the numbers in various groups were small. In order to be considered a therapeutic option in locally advanced patients, NACT followed by surgery must be compared to the current therapeutic standard, which is concurrent chemoradiation. The chemotherapeutic options for cervical cancer at present are different from the one used by Sardi et al. The combination of ifosfamide and cisplatin or paclitaxel and carboplatin is likely to show a higher response rate compared to the regimen used by Sardi et al, which was bleomycin, vincristine and cisplatin.

Considering these results from the literature, it appears logical to compare neoadjuvant chemotherapy followed by surgery with concurrent chemoradiation in patients with stage IB2 to IIB squamous carcinoma of the cervix.

Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix

A Prospective Randomized Trial of Neoadjuvant Chemotherapy and Surgery Versus Concurrent Chemoradiation Therapy in Patients With Stage IB2-IIB Squamous Carcinoma of the Uterine Cervix

Disease free survival will be calculated from the date of entry into the study to the date of first physical or radiographic evidence disease relapse or death due to disease or last follow up visit.

Over all survival will be calculated from the date of entry into the study to the date of death due to any cause or the last follow up visit.

Tata Memorial Hospital

Professor of Medical Oncology

Docetaxel

Participant will receive at least 2 cycles of adjuvant chemotherapy. If having any of the following factors, participant will receive additional 2 cycles of adjuvant chemotherapy per risk factor. All patients received maximum 6 cycles of postoperative chemotherapy.

Risk factors: (1) Deep cervical invasion（≥ 2/3）；（2）Differentiation grade 2-3；（3）Lymphatic vascular space infiltration；（4）Adenocarcinoma or adenosquamous carcinoma；（5）Tumor size ≥ 4cm before surgery.

The participants receive no intervention.

Drug: Paclitaxel or docetaxel + Cisplatin or carboplatin Paclitaxel 135-175mg/m2 over 3 hours or docetaxel 70-75 mg/m2， 30min ＋ Cisplatin 75-80mg/m2 or carboplatin AUC = 5, repeat per 21 days.

Adjuvant chemotherapy

Ding Ma, M.D., PhD

This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size\> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.

Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery

DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first.

OS is defined as the time from the date of randomization until death of any cause.

Patients are asked to complete the questionnaire EORTC QLQ-C30

Patients are asked to complete the questionnaire EORTC QLQ-CX24

The toxicity induced by chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 5.0.

Women's Hospital School Of Medicine Zhejiang University

Qilu Hospital of Shandong University

Obstetrics & Gynecology Hospital of Fudan University

First Affiliated Hospital of Chongqing Medical University

Hunan Cancer Hospital

The Third Xiangya Hospital of Central South University

Huazhong University of Science and Technology

Tongji Hospital, Tongji Medical College

Taxane

NACT with Taxane combined with cisplatin and Fertility-sparing Treatment Strategy

NACT and Fertility-sparing Treatment Strategy

radical trachelectomy

Yanling Feng, Doctor

Jihong Liu, Ph.D.

Yanling Feng, Ph.D.

Jihong Liu, PhD

Patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function will be recruited. Before treatment, MRI scanning will be used to exclude retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma.If there is no macroscopic tumor and no obvious disease in MRI,simple trachelectomy (ST) + sentinel lymph node biopsy (SLNB) / retroperitoneal lymph node dissection(RPLND) will be performed. Otherwise,two to three cycles of neoadjuvant chemotherapy (NACT) will be administrated and then different fertility-sparing surgery(conization,ST or radical trachelectomy(RT) + SLNB/RPLND) will be employed depending on the tumor size.

The age of patients who are diagnosed with cervical cancer has decreased, resulting in a trend of increasingly younger patients who seek to preserve their fertility. Therefore, a less radical approach that aims to preserve the potential for fertility during the treatment of cervical carcinoma is crucial. Herein, the investigators devote to exploring optimal fertility-sparing treatment strategy in Patients With cervical cancer.

In this study, patients with cervical cancer staging IB1-IIA2 desiring keeping their fertility function will be recruited. Before treatment, MRI scanning will be used to exclude retroperitoneal lymph node metastasis, involvement of lower part of uterus and endometrial carcinoma.

All lymph nodes and margin should be pathologic reviewed during the surgery. Fertility-sparing surgery should be abandoned if positive lymph node is found.

If there is no macroscopic tumor and no obvious disease in MRI, ST+ SLNB/RPLND will be performed. Otherwise, two or three cycles of NACT will be administrated and then chemotherapy response will be assessed with physical examination and MRI scanning.

If there is no obvious residual disease after NACT, the colposcopy will be used to search for the suspicious disease in the cervix and on the vaginal wall. If there is no disease on the vaginal wall, the conization and SLNB / RPLND is employed. If pathologic review finds no residual disease or the residual disease is more than 5 mm away from cone margin, the surgery procedure ceases; If pathologic review finds the residual disease is less than 5 mm away from cone margin, ST± upper vaginal margin resection is performed.

If the residual disease is less than 2cm in diameter, simple trachelectomy (ST) ± upper vaginal margin resection and SLNB/ RPLND is employed.

If the residual disease is greater than 2 cm and less than 4cm in diameter, radical trachelectomy (RT) and SLNB/ RPLND is employed.

If the residual disease is greater than 4 cm in diameter, fertility-sparing surgery should be abandoned.

Tow to three cycles of adjuvant chemotherapy will be administrated after the fertility-sparing surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LYmphadenectomy After NeoAdjuvant Chemotherapy	NCT01724944	Advanced Ovaria...	Systematic pelv...	18 Years - 75 Years	Catholic University of the Sacred Heart
LYmphadenectomy After NeoAdjuvant Chemotherapy	NCT01724944	Advanced Ovaria...	Systematic pelv...	18 Years - 75 Years	Catholic University of the Sacred Heart
Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix	NCT00193739	Cancer of Cervi...	NACT Radical abdomin... Inj.Cisplatin Concurrent chem...	18 Years - 65 Years	Tata Memorial Hospital
Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery	NCT04733820	Uterine Cervica... Cervical Cancer	Adjuvant chemot...	18 Years - 70 Years	Huazhong University of Science and Technology
Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix	NCT00193739	Cancer of Cervi...	NACT Radical abdomin... Inj.Cisplatin Concurrent chem...	18 Years - 65 Years	Tata Memorial Hospital
Prospective Study of Fertility-sparing Treatment Strategy in Patients With Early Cervical Cancer(SYSUGO-005/CSEM009)	NCT02624531	Cervical Cancer	Taxane radical trachel...	18 Years - 40 Years	Sun Yat-sen University
Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix	NCT00193739	Cancer of Cervi...	NACT Radical abdomin... Inj.Cisplatin Concurrent chem...	18 Years - 65 Years	Tata Memorial Hospital

Spots Global Cancer Trial Database for nact

Every month we try and update this database with for nact cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for nact

Every month we try and update this database with for nact cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nact cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.