Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Pathologic Complete Response

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

4 cycles of neoadjuvant paclitaxel plus carboplatin

Paclitaxel 80 mg/m2, carboplatin AUC of 2 mg/min/ml, given on days 1, 8 and 15 of a 28-day cycle.

Paclitaxel, Carboplatin

Kunwei Shen, Dr

The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel plus carboplatin preoperative regimen.

Breast cancer is the leading cause of cancer in women in China. Preoperative chemotherapy for treatment of locally advanced breast cancer has become a standard therapy. Results from neoadjuvant trials have shown that pathological complete response (pCR) is an independent predictor of outcome. Paclitaxel was introduced into clinical practice in the early 1990s and has demonstrated good activity in the adjuvant and metastatic settings. Platinum complexes, like cisplatin and carboplatin, are active in a wide range of solid tumors. Paclitaxel combined with carboplatin has shown great activity in ovarian and nonsmall- cell lung cancer treatment. In addition, the overall response rate of paclitaxel plus carboplatin was between 53% and 62% in the first-line treatment of metastatic breast cancer. This study will evaluate the pCR rate of weekly paclitaxel plus carboplatin as preoperative treatment for breast cancer patients.

Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer

Phase 2 Study of Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer Patients

From the first dose of neoadjuvant chemotherapy to definitive surgery or disease progression

Fudan University

Ruijin Hospital

Shanghai Jiao Tong University School of Medicine

Kunwei Shen/Shanghai Jiao Tong University

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

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

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Hematinics

Liver Extracts

For patients whoes WB-DWI/MRI Suidan Standard Evaluation≥4 Neoadjuvant chemotherapy: platinum-based combination regimen 3 courses

For patients whoes WB-DWI/MRI Suidan Standard Evaluation\<4

Paclitaxel 175mg/m2 iv d1 followed by Carboplatin(AUC=5) iv d1

Remove all visible tumors and any other tissues or organs where tumor may have spread, which may include:

Uterus Fallopian tubes Omentum (tissue that covers the stomach, large intestine and other abdominal organs) Lymph nodes Diaphragm Part of the large bowel Spleen Parts of the liver

debulking surgery

Xiaohua Wu, PhD&MD

Zheng Feng, PhD

Epithelial ovarian cancer is mostly diagnosed at late stage (III/IV), and the standard treatment for ovarian cancer includes primary debulking surgery and platinum-based adjuvant chemotherapy. However, scholars suggest that neoadjuvant chemotherapy can be used to reduce the tumor load and control the patient's condition. The aim of this study is to verify the efficacy of primary debulking surgery versus neoadjuvant chemotherapy.

Epithelial ovarian cancer (EOC) is one of the most common malignant tumors in women. Due to the insidious onset and the lack of effective early diagnosis measures, about 70% of patients with epithelial ovarian cancer are already in FIGO stage III-IV at the time of diagnosis. With extensive tumor dissemination and metastasis, the 5-year survival rate of EOC patients is only about 30-40%.

Currently, the standard treatment for ovarian cancer remains to include primary debulking surgery(PDS) and platinum-based adjuvant chemotherapy. Despite the lack of evidence from prospective randomized controlled studies, evidence invariably shows that satisfactory debulking surgery improves survival prognosis in advanced ovarian cancer and that this benefit is significantly associated with the amount of residual lesion.

How to increase the proportion of patients with satisfactory tumor reduction (residual lesions \<1 cm) has long been a pressing issue for gynecologic oncologists. However, because ovarian cancer lesions are mainly disseminated in the pelvic cavity, the extent of surgery to achieve satisfactory reduction is often large and difficult to be tolerated for some patients. At the same time, due to the large initial tumor or the limited treatment level, some patients are unable to obtain satisfactory cytoreduction. Therefore, some scholars suggest that neoadjuvant chemotherapy (NACT) can be used to reduce the tumor load and control the patient's condition, followed by interval debulking surgery (IDS), called NACT-IDS treatment model.

Whether the NACT-IDS treatment model can be used as a conventional alternative to PDS has been controversial. The foundation for NACT-IDS was laid by two multicenter randomized controlled phase III clinical trials, EORTC 55971 and CHORUS. Both studies showed that the application of NACT in patients with advanced ovarian cancer resulted in a higher proportion of satisfactory cytoreduction and lower postoperative complications and mortality while ensuring a similar prognosis. However, the two studies mentioned above have been questioned by some scholars because of the lower median operative time, lower percentage of satisfactory cytoreduction, and lower patient prognosis than the international general level. Meanwhile, another phase III randomized controlled clinical trial, JCOG0602, was a non-inferiority trial, and the results did not confirm that NACT was not inferior to PDS. Therefore, at present, NCCN guidelines recommend that PDS remains the first choice for most patients.

At present, there are no relevant clinical trials comparing the impact of PDS with NACT on the prognosis of patients with ovarian cancer. In this study, investigators propose to assess the resectability of patients with abdominopelvic lesions using the Suidan standard resectability prediction model based on the evaluation of WB-DWI/MRI. In patients of stage IV ovarian cancer with resectable abdominopelvic lesions, the prognostic impact of PDS and NACT will be compared prospectively and randomly, with the aim of providing a new decision basis for the treatment of patients with stage IV ovarian cancer.

Efficacy of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Stage IV Ovarian Cancer

Efficacy of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Stage IV Ovarian Cancer: a Phase III Randomized Controlled Study

R0: no residue under the microscope after resection R1: residue≤1cm R2: tumor residue visible to the naked eye(\>1cm)

Patients from surgery or neoadjuvant chemotherapy to disease progression or time to last follow-up

Patients from surgery or neoadjuvant chemotherapy to death or time to last follow-up

Professor

Uterine Neoplasms

Cystadenocarcinoma, Serous

Uterine Diseases

Andreas Obermair

This study will be an open, non-randomised, clinical phase 2 trial, which will involve 30 women diagnosed with uterine papillary serous cancer. The researchers will investigate the effect of four cycles of paclitaxel/carboplatin, followed by whole pelvic external beam radiotherapy to a standard pelvis field (50.4 Gy) with or without a para-aortic boost with respect to the safety and efficacy of treatment, and patterns of recurrence.

Trial Objectives:

* To assess the safety and efficacy of the combination of Paclitaxel and Carboplatin +/- pelvic radiotherapy in the treatment of UPSC.
* To observe the patterns of recurrence following the administration of the combination of Paclitaxel and Carboplatin +/- pelvic radiotherapy in the treatment of UPSC.
* To assess the QOL, overall survival and disease free survival.

Treatment

Surgery: Total abdominal hysterectomy, bilateral salpingo-oophorectomy, +/- pelvic and aortic node sampling, omentectomy, peritoneal cytology.

Chemotherapy: Chemotherapy commences at the surgeon's and the medical oncologist's discretion and the time between surgery and start of chemotherapy will be recorded. One treatment cycle consists of 3 weeks.

Paclitaxel and Carboplatin will be administered as follows:

Day 1:

* Diphenhydramine 50 mg IV or po or phenergan 12.5 - 25 mg IV
* Cimetidine 300 mg or ranitidine 50 mg IV
* Dexamethasone 20 mg IV
* Paclitaxel 175 mg/m2
* Carboplatin AUC 6

Day 22: Repeat the cycle. This is Day 1 of the second cycle.

Day 43: Repeat the cycle. This is Day 1 of the third cycle.

Day 64: Repeat the cycle. This is Day 1 of the fourth cycle.

Day 85: After the fourth cycle of chemotherapy patients

Patients with stage 4 disease will continue with chemotherapy for a total of 6 cycles.

Patients with surgical stage 1b to 3c disease will receive whole pelvis external beam radiotherapy (50.4 Gy RD over 5 and a half weeks +/- paraaortic boost +/- vaginal vault brachytherapy boost). Radiotherapy will start 4 to 6 weeks after commencement of chemotherapy when the haematological count has recovered.

Uterine Papillary Serous Cancer (UPSC) Trial

Prospective, Non-randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer

Queensland Centre for Gynaecological Cancer

Prof Andreas Obermair

Anti-Infective Agents

Epirubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.

Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.

Paclitaxel, Epirubicin

Zhongsheng Tong, Master

Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

A Randomized Prospective Clinical Trial of Paclitaxel in Combination with Carboplatin Versus Paclitaxel plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer

A Randomized Prospective Clinical Trial of Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer	NCT01203267	Breast Cancer	Paclitaxel, Car...	18 Years - 70 Years	Shanghai Jiao Tong University School of Medicine
Efficacy of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Stage IV Ovarian Cancer	NCT05371301	Ovarian Cancer	Paclitaxel, Car... debulking surge...	18 Years -	Fudan University
Uterine Papillary Serous Cancer (UPSC) Trial	NCT00147680	Uterine Cancer	Paclitaxel, Car...	18 Years -	Queensland Centre for Gynaecological Cancer
Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer	NCT01203267	Breast Cancer	Paclitaxel, Car...	18 Years - 70 Years	Shanghai Jiao Tong University School of Medicine
Efficacy of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Stage IV Ovarian Cancer	NCT05371301	Ovarian Cancer	Paclitaxel, Car... debulking surge...	18 Years -	Fudan University
Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer	NCT02207361	Metastatic Brea...	Paclitaxel, Car... Paclitaxel, Epi...	18 Years -	Tianjin Medical University Cancer Institute and Hospital
Efficacy of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Stage IV Ovarian Cancer	NCT05371301	Ovarian Cancer	Paclitaxel, Car... debulking surge...	18 Years -	Fudan University
Uterine Papillary Serous Cancer (UPSC) Trial	NCT00147680	Uterine Cancer	Paclitaxel, Car...	18 Years -	Queensland Centre for Gynaecological Cancer

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