Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Pathologic Complete Response

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Disease Progression

Disease Attributes

Those patients with rectal cancer after neoadjuvant treatment and completed the examination of TRUS-FNA, TRUS, CT, MR, enteroscopy and superficial biopsy

Transrectal Ultrasound Guided Fine Needle Aspiration for rectal tumor

TRUS-FNA

luo yanxin, MD,PHD

Colorectal cancer is one of the most malignancies worldwide. The dominant clinical research strategy of LARC includes neoadjuvant chemoradiotherapy before radical surgery followed combined with adjuvant treatment. Approximately 15% to 20% of the patients after nCRT can achieve a pathologic complete response (pCR)---no residual tumor is reported at histology after a standard resection. Some researchers suggest that those patients with pCR can be spared the morbidities of surgery instead by a nonoperative approach---watch- and-wait(W\&W). However, neither FDG-PET, MRI, CT, nor enteroscopy can accurately determine a pCR.

EUS-FNA has been an important technique for the diagnosis of rectal cancer for its high accuracy and little harm. However, data on the TRUS-FNA for the cytologic diagnosis of pCR in rectal cancer is scarce. Our hypothesis is that adding transrectal ultrasound-guided fine needle aspiration (TRUS-FNA) compared with enteroscopy , MR, and CT alone can improve the accuracy of predicting pCR after nCRT.Therefore, the aim of the study is to assess the performance characteristics of EUS-FNA in this setting.

Following the neoadjuvant treatment of rectal cancer, appropriately 15-20%of patients receiving neoadjuvant treatment can achieve pathological complete response: a condition of no tumor cell detected in surgical specimens, which usually suggests improved oncology outcomes. In 2004, Habr-Gama, A et al. proposed that surgical resection may not increase overall and disease-free survival in these patients and lead to an increased risk of surgical complications and permanent stoma. Therefore, they suggested that nonoperative treatment, which is now referred to as "watch-and-wait"--patients with clinical complete response (cCR) can avoid unnecessary surgery and be managed by strict follow-up and observation alone. A series of studies have shown impressive survival outcomes in patients who received nonoperativetreatment:85-93% and 82-94% in 5-year overall survival and disease-free survival, respectively. Also, in case of relapse, the rate of successfully performed salvage surgery was 80-91%.

However, determining pCR after neoadjuvant treatment for distal rectal cancer remains a dilemma for clinicians. Different imaging modalities, including digital rectal examination (DRE), fludeoxyglucose positron emission tomography (FDG-PET), Computed Tomography (CT), magnetic resonance imaging (MRI), transrectal ultrasound (TRUS) and endoscopy have been well evaluated for the efficacy of predicting pCR. In contrast, none of them proved to be reliable.

Duldulao et al. found that after neoadjuvant treatment, rectal tumor cells are distributed preferentially in the muscularis of the bowel wall while few in the mucosa. That is why superficial biopsies were inadequate, and full-thickness apparitions on tumor focus may provide adequate sampling to rule out malignancy for all stages of rectal cancer after neoadjuvant treatment. Therefore, fine-needle aspiration assisted with TRUS (TRUS-FNA), which can harvest a whole layer of the bowel wall, has shown obvious advantages in this setting.

Although widely used in clinical practice, studies regarding the application of TRUS-FNA in predicting pCR after preoperative therapy of rectal cancer were scarce. We hypothesized that TRUS-FNA could improve the clinical practice of identifying patients achieving pCR after neoadjuvant treatment. Accordingly, we conducted this prospective study to evaluate the efficacy of TURS-FNA, compared with other imaging modalities, TRUS, MRI, CT, enteroscopy, and superficial biopsy, in predicting pCR of rectal cancer after neoadjuvant treatment.

TRUS-FNA For The Prediction Of pCR After Neoadjuvant Treatment In Rectal Cancer

TRUS-FNA Versus MRI， CT， Enteroscopy, Superficial Biopsy, TRUS For The Prediction Of pCR After Neoadjuvant Treatment In Rectal Cancer

there is no plan to make individual participant data (IPD) available to other researchers.

The primary endpoint was the predictive yield of TRUS-FNA for pathological complete responses after neoadjuvant treatment.

Sixth Affiliated Hospital, Sun Yat-sen University

Chief Physician

Skin and Connective Tissue Diseases

Breast Neoplasms

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

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Micronutrients

Hematinics

Anti-Infective Agents

Vitamins

Docetaxel

Leucovorin

Fluorouracil

Cisplatin

Epirubicin

Oxaliplatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Folate

Vitamin B9

Docetaxel 50mg/m2, d1 5-FU 2600 mg/m², d1 Leucovorin 200 mg/m², d1 Oxaliplatin 85 mg/m², d1 every two weeks (q2w) 4 cycles (8 weeks) pre-OP and 4 cycles (8 weeks) post-OP

Epirubicin 50 mg/m2, d1 Cisplatin 60 mg/m², d1 5-FU 200 mg/m², d1-d21 every 3 weeks (q3w) 3 cycles (9 weeks) pre-OP and 3 cycles (9 weeks) post-OP

5-Fluorouracil

5-fluorouracil

Salah-Eddin Al-Batran, MD

Patients with locally advanced resectable adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be treated with one of two chemotherapy combinations before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Epirubicin, Cisplatin and 5-FU (ECF). Main objective of the study is median overall survival.

714 Patients with locally advanced resectable (T2-4 and/or N+, M0) adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or 3 cycles ECF, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or 3 cycles ECF are applicated. Then a central validation of the pathological remission rate is scheduled. Primary endpoint is overall survival, secondary endpoints are disease free survival, perioperative morbidity and mortality, histopathologic regression rate and R0-resection rate.

5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer

A Randomized Multicenter Phase II/III Study Comparing 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced Resectable Adenocarcinoma of the Esophagogastreal Junction or the Stomach

Krankenhaus Nordwest

Principal Investigator

Antirheumatic Agents

Cyclophosphamide

Pirarubicin

Antineoplastic Agents, Alkylating

Alkylating Agents

pirarubicin 50mg/m2, iv, d1; docetaxel 75mg/m2, div, d1. 21 days were a cycle of treatment, with a total of 4-8 cycles.

cyclophosphamide 600mg/m2, iv, d1; Pirarubicin 60mg/m2, iv, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Then followed by Docetaxel 75- 100mg/m2, div, d1, 21 days were a cycle of treatment, with a total of 4 cycles.

Shikai Wu

The purpose of this study is to compare the short-term and long-term efficacies and the safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.

Based on the results of NSABP(National Surgical Adjuvant Breast and Bowel Project) B27 trial, anthracyclines(A) and Taxanes(T) are most commonly recommended in neoadjuvant chemotherapy of breast cancer.

Pirarubicin is one of anthracyclines and by embedding the DNA double stranded, which inhibits DNA replication and RNA synthesis, thereby impedes the rapid growth of cancer cells.

Docetaxel in one of taxanes and by strengthening the tubulin polymerization, inhibiting of microtubule depolymerization and leading to the formation of stable non functional microtubule bundles, which destroys mitosis of tumor cells.

Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer

Comparative Analysis of the Efficacies of AT and AC-T Regimens in Neoadjuvant Chemotherapy of Breast Cancer

307 Hospital of PLA

Chief Physician,Department of Radiotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TRUS-FNA For The Prediction Of pCR After Neoadjuvant Treatment In Rectal Cancer	NCT04939103	EUS-FNA Rectal Cancer Pathological Co...	TRUS-FNA	18 Years -	Sixth Affiliated Hospital, Sun Yat-sen University
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
5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer	NCT01216644	Gastric Cancer	5-Fluorouracil Leucovorin Oxaliplatin Docetaxel Epirubicin Cisplatin 5-fluorouracil	18 Years -	Krankenhaus Nordwest
Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer	NCT02613026	Breast Neoplasm...	Pirarubicin Docetaxel Cyclophosphamid...	18 Years - 70 Years	307 Hospital of PLA
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
TRUS-FNA For The Prediction Of pCR After Neoadjuvant Treatment In Rectal Cancer	NCT04939103	EUS-FNA Rectal Cancer Pathological Co...	TRUS-FNA	18 Years -	Sixth Affiliated Hospital, Sun Yat-sen University
5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer	NCT01216644	Gastric Cancer	5-Fluorouracil Leucovorin Oxaliplatin Docetaxel Epirubicin Cisplatin 5-fluorouracil	18 Years -	Krankenhaus Nordwest
Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer	NCT02613026	Breast Neoplasm...	Pirarubicin Docetaxel Cyclophosphamid...	18 Years - 70 Years	307 Hospital of PLA

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