Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Capecitabine

Leucovorin

Fluorouracil

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Neoadjuvant Capecitabine concomitant to external beam radiotherapy

Capecitabine Oral Product

Neoadjuvant bolus 5-Fluorouracil concomitante to external beam radiotherapy

5Fluorouracil

A randomized two-arm study comparing preoperative CRT using oral capecitabine versus bolus 5-FU/LV concomitant to external beam radiation (50.5 Gy/28 fractions) for locally advanced rectal cancer. Main outcome was clinical response assessed using MRI and endorectal US 6-8 weeks after CRT. Secondary endpoints were pathological response, adverse effects, sphyncter preservation, quality of life, OS and DFS.

Patients harbouring rectal adenocarcinoma T3-4 or N\>0 M0 within 10 cm to anal verge were randomized in two treatment arms: (1) capecitabina orally 825mg/m2 bid. 5 days a week for 5 weeks and (2) bolus intravenous 5-FU/LV 350mg/m2/20 mg/m2 D1-D5 on the first and fifth weeks, both combined to pelvic radiotherapy, total dose 50.4 Gy in 28 fractions. Clinical stage before and after CRT was determined using pelvic Magnetic Resonance Imaging (MRI), endorectal ultrasonography (ERUS) and chest, abdominal and pelvic Computer Tomography. Surgery was planned 6 to 8 weeks after CRT. Sphincter preservation was always considered when negative margins were possible. Pathological assessment included stage (TNM 7th Ed.) and Mandard's Tumor Regression Grade (TRG). QOL questionnaires QLQ-C30 and CR38 were completed by patients before and after CRT, after surgery and during follow-up.

Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.

Estudo Randomizado de Fase II Com Capecitabina Versus 5-Fluorouracil/Leucovorin em Bolus Associados à Radioterapia no Tratamento Neoadjuvante de câncer de Reto Localmente avançado: INCAGI004.

IPD could be shared if requested after IRB approval.

Clinical downstaging after neoadjuvant treatment

Patholgical downstaging after neoadjuvant treatment

Instituto Nacional de Cancer, Brazil

Dr. Rodrigo Otavio de Castro Araujo

Symptoms and General Pathology

Rare Diseases

Neoplasm Metastasis

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Hematinics

Temozolomide

Liver Extracts

Antineoplastic Agents, Alkylating

Alkylating Agents

Capecitabine 750 mg/m2 twice daily orally for 14 days and temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles, to be continued until 1) disease progression or 2) intolerable toxicities.

Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.

Capecitabine 750 mg/m2 twice daily orally for 14 days

temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles

Temozolomide Oral Product

Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.

transarterial radioembolization

Michael Soulen, MD

Kathleen Thomas

Deepon Paul Singh

Renuka Iyer, MD

Abashai Woodard

Michael Soulen

This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy alone.

Patients with liver-dominant Grade 2 NET metastases from any primary will start CapTem and undergo simulation angiography for radioembolization planning during the first cycle. If they tolerate CapTem and are not excluded from radioembolization, then TARE will be performed on Day 7 of Cycle 2, with additional TARE of Day 7 of cycle 3 or 4 as needed to treat the entire tumor burden. Patients will remain on CapTem until progression or intolerance.

Primary outcome measure is hepatic progression-free survival.

CapTemY90 for Grade 2 NET Liver Metastases

UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2 Neuroendocrine Tumors

Intra-hepatic progression-free survival by RECIST 1.0 is defined as the time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.

Overall progression-free survival is defined as the time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status

Intra-hepatic tumor responses will be evaluated by RECIST.

Intra-hepatic tumor responses will be evaluated by EASL criteria.

extra-hepatic tumor responses will be evaluated by RECIST.

Systemic toxicities will be individually assessed by NCI CTCAE Version 4.

Hepatic toxicities will be individually assessed by NCI CTCAE Version 4.

The primary marker is CgA. Additional cancer site-specific (i.e., gastrinoma) markers may also be assayed.

Quality of Life will be measure by a validated NET-specific instrument, EORTC. Scale is 0-100, higher scores indicate worse symptoms/functioning

Roswell Park Cancer Institute

CARTI

Abramson Cancer Center at Penn Medicine

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Hormones

Fulvestrant

Mitogens

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Fulvestrant 500mg Days 0, 14, 28, then every 28 days

Capecitabine 2000mg/m2 twice daily x 14 days followed by 7 days off

Herui Yao, PhD

Wenjing Wu, PhD

Kun Wang, PhD

Li Ling, PhD

Shusen Wang, PhD

Mei Huang, MD

Ying Lin, PhD

Zhiyong Wu, MD

Caiwen Du, PhD

Ruilian Xu, Master

Ying Zhang, MD

Peijian Peng, PhD

Yongkui Lu, MD

Quchang Ouyang, PhD

Ying Lin, phD

Cai'wen Du, PhD

This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer.

Metastatic breast cancer (MBC) is incurable. Although first-line endocrine therapy is preferred to hormone receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) MBC, chemotherapy may be reserved as the initial treatment for patients with rapid clinical progression, life-threatening visceral metastases, and need for rapidly symptom control. Either prolonged chemotherapy or endocrine therapy may be used as maintenance after disease control. However, which maintenance strategy is superior in terms of delaying disease progression as well as maintaining quality of life (QOL) remains uncertain. This phase III trial aims to compare the efficacy and safety of fulvestrant or capecitabine as maintenance therapy after first-line chemotherapy in HR+/HER2- MBC.

Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer

A Randomized, Multi-center, Open-label, Phase III Trial of Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer (FAMILY)

From enrollment to progression or death (for any reason)

From enrollment to death (for any reason)

Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects

All patients need to fill in the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.	NCT03428529	Rectal Neoplasm...	Capecitabine Or... 5Fluorouracil	18 Years - 80 Years	Instituto Nacional de Cancer, Brazil
CapTemY90 for Grade 2 NET Liver Metastases	NCT04339036	Neuroendocrine ... Neuroendocrine ...	Capecitabine Or... Temozolomide Or... transarterial r...	18 Years -	Abramson Cancer Center at Penn Medicine
Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.	NCT03428529	Rectal Neoplasm...	Capecitabine Or... 5Fluorouracil	18 Years - 80 Years	Instituto Nacional de Cancer, Brazil
CapTemY90 for Grade 2 NET Liver Metastases	NCT04339036	Neuroendocrine ... Neuroendocrine ...	Capecitabine Or... Temozolomide Or... transarterial r...	18 Years -	Abramson Cancer Center at Penn Medicine
Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer	NCT04263298	Metastatic Brea...	Fulvestrant Capecitabine Or...	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.	NCT03428529	Rectal Neoplasm...	Capecitabine Or... 5Fluorouracil	18 Years - 80 Years	Instituto Nacional de Cancer, Brazil

Spots Global Cancer Trial Database for capecitabine oral product