Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Patients in this group will receive neoadjuvant chemotherapy.

Patients in this group will receive neoadjuvant chemoradiation therapy.

Paclitaxel 175mg/m2 plus Cisplatin 75mg/m2, q21d, 2 cycles

Paclitaxel, Cisplatin

Paclitaxel 50mg/m2 plus Carboplatin AUC=2, q1w, 5 cycles; 41.4Gy, 1.8Gy/d\*23

neoadjuvant chemoradiation therapy

Haibo Sun

Multimodal treatment combining surgery with chemotherapy and/or radiotherapy is necessary to improve the chances of survival in patients with locally advanced thoracic esophageal cancer. However, there is no consensus about the neoadjuvant treatment for resectable locally advanced esophageal squamous cell carcinoma. The aim of current randomized controlled clinical trail is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiation therapy plus surgery on overall survival for patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 456 patients with locally advanced esophageal squamous cell carcinoma in 3 years. Eligible patients will be randomized into neoadjuvant chemotherapy group (paclitaxel 175mg/m2 plus cisplatin 75mg/m2, q21d, 2 cycles) or neoadjuvant chemoradiation group (41.4Gy, 1.8Gy\*23d plus paclitaxel 50mg/m2 plus carboplatin AUC=2, q1w, 5 cycles). The primary endpoint is 5 year overall survival and the secondary endpoints include 5 year disease-free survival, adverse events, pathologic complete response, postoperative complications, quality of life. The biomarkers predicting the sensitivity of neoadjuvant therapy will be explored.

Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)

Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903)

Henan Cancer Hospital

Attending surgeon

Symptoms and General Pathology

Microsatellite Instability

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Genomic Instability

Immunomodulating Agents

neoadjuvant chemoradiation therapy +immunotherapy

neoadjuvant chemoradiation therapy +xintilimab injection 200mg/3week 4cycle

xintilimab injection

Control

Wei Zhang

At present, there are no relevant studies or reports on the effect of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer. Studied in this paper combin neoadjuvant chemoradiation with immune therapy, carry out "Multicenter prospective randomized clinical trial of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer" in order to provide a high-level evidence-based medical evidence for ultra-low rectal cancer treatment and improve ultra-low rectal cancer diagnosis and treatment effect.

Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer

Multicenter Prospective Randomized Clinical Trial of Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer

IPD would be available upon reasonable request.

Rate of patients who achieve clinical complete response

Rate of patients who achieve organ preservation

Rate of patients who achieve anus preservation

DFS was defined as the duration from the date of randomization to the date of the first recurrence (local, distant, or mixed) or death.

OS was calculated from the date of randomization.

The QoL was assessed by EORTC QOL Core Questionnaire.

Changhai Hospital

Chief physician, professor

All patients enrolled will be placed in Arm A. Serum blood draw samples will be collected as well as additional data from medical records will be collected. This data includes demographic data, clinical information from notes, radiology images and reports, diagnostic test results, and procedure and pathology reports.

Serum samples will be obtained from each patient enrolled

Blood Draw

Leah K Miller, MS

Michelle Faucheux, RN

Leah Miller, MS

Mindi TenNapel, PhD

Andrew Hoover, MD

The primary aims of this study is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy. Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. The researchers will also examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.

All male and female patients, aged 18 and older with a histologically proven diagnosis of rectal adenocarcinoma, treated on this study will receive neo adjuvant chemotherapy (consisting of 5 FU or capecitabine) given concurrently with external beam radiation therapy to a dose of 50.4 Gy in 28 fractions. Radiation treatments will be administered daily, Monday thru Friday. Within one week prior to beginning chemotherapy and radiation treatments, a serum sample will be obtained from each patient. Patients will also have serum samples collected every two weeks during radiation, and on the last day of radiation therapy, as well as at their one month follow up visit after completion of radiation and prior to planned surgery. A final serum sample will be collected within one month after definitive surgery. Each serum sample collected will be less than 50 mL.

The study will involve obtaining serum samples from patients before during and after chemoradiation therapy. These serum samples will be analyzed to determine exosomal biomarker levels, which will be correlated with clinical, imaging, laboratory, and pathologic data obtained from the medical record.

Additional data from the patients' medical records will be collected, including demographic data, clinical information from notes in the medical record, radiology images and reports, results of diagnositic tests, and information from procedure notes and pathology reports.

blood serum samples will be collected from patients before, during, and after chemoradiation therapy. These samples will be analyzed and stored for 10 years

Exosomes in Rectal Cancer

Exosomal as Correlative Biomarker in Clinical Outcomes in Patients Undergoing Neoadjuvant Chemoradiation Therapy for Rectal Cancer

Characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy.

Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. Response rates will be graded based on College of American Pathologists Guidelines on neoadjuvant treatment effect, which consist of a 4 tiered grading system categorizing response to neoadjuvant chemoradiation as "complete", "moderate", "minimal", or "poor". These grades are routinely documented in pathology reports for patients undergoing neoadjuvant chemoradiation for rectal cancer and will be obtained from review of pathology reports in the patient medical records.

Examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.

University of Kansas Medical Center

Principle Investigator

Micronutrients

Hematinics

Vitamins

Leucovorin

Fluorouracil

Oxaliplatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Locally advanced rectal cancer receiveing total neoadjuvant treatment

Patients receive mFOLFOX6 for 4 cycles during neoadjuvant radiotherapy, and after CRT, another 4 cycles of mFOLFOX6 would be given before surgery.

mFOLFOX6

Patietns received preoperative radiotherapy, 1.8-2.0GY/23-25F

Radiotherapy

Yanhong Deng, PhD

Yanhong Deng, Phd

Preoperative 5FU based chemoradiotherapy is still the standard of treatment for locally advanced rectal cancer. About 15-20% of patients would achieve pathologic complete response (pCR) after neoadjuvant CRT, and the survival outcome was much better than that of non-pCR. Total neoadjuvant treatment had been evaluated a lot in recent years, including induction chemotherapy or consolidation chemotherapy, or concurrent chemoradiotherapy. We aimed to evaluated the safety and efficacy of total neoadjuvant treatemnt in locally advanced rectal cancer.

Preoperative 5FU based chemoradiotherapy is still the standard of treatment for locally advanced rectal cancer. About 15-20% of patients would achieve pathologic complete response (pCR) after neoadjuvant CRT, and the survival outcome was much better than that of non-pCR. However, distant metastasis would occur in about 30% of patients even after CRT. To improve the survival of rectal cancer patients, we hope to improve the pCR rate. In our previous FOWARC study, mFOLFOX6 with radiation had the pCR rate of 27.5%. It had been reported that adding FOLFOX after neoadjuvant chemo radiation in locally advanced rectal cancer would improve pCR rate. Nowadays, induction or consolidation chemotherapy or concurrent chemoradiotherapy had been used in clincal practice. Here, we are going to evaluate the safety and efficacy of total neoadjuvant therapy in real world.

FOLFOX6 Totally Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer: A Real World Study

Totally Neoadjuvant Chemoradiation Therapy With mFOLFOX6 in Locally Advanced Rectal Cancer: A Real World Study

The pathologic outcome after neoadjuvant CRT showed no tumor residual.

The adverse events after total neoadjuvant treatment

Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I

3 years recurrence free survival of this group of patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)	NCT04138212	Esophageal Squa...	Paclitaxel, Cis... neoadjuvant che...	18 Years - 70 Years	Henan Cancer Hospital
Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer	NCT05215379	Neoadjuvant Che... Rectal Cancer Immunotherapy Microsatellite ...	xintilimab inje... Control	18 Years - 75 Years	Changhai Hospital
Exosomes in Rectal Cancer	NCT03874559	Rectal Cancer	Blood Draw	18 Years -	University of Kansas Medical Center
FOLFOX6 Totally Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer: A Real World Study	NCT02887313	Rectal Cancer	mFOLFOX6 Radiotherapy	18 Years - 75 Years	Sun Yat-sen University
Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer	NCT05215379	Neoadjuvant Che... Rectal Cancer Immunotherapy Microsatellite ...	xintilimab inje... Control	18 Years - 75 Years	Changhai Hospital

Spots Global Cancer Trial Database for neoadjuvant chemoradiation therapy