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

Chairat Supsamutchai, MD

Due to colorectal cancer is the fourth most common malignancy in the world. Some patients had present locally advance stage and need to preoperative concurrent chemoradiation (CCRT) before radical surgery. But predictor for pathologic complete response (pCR) after preoperative CCRT remain unclear.

Objectives: To identify possible factor for predict of pCR of rectal cancer after preoperative CCRT.

After permission was obtained from our institutional review board, a cohort of patients who were diagnosed with rectal cancer and received chemoradiation between January 2011 to December 2017 at Ramathibodi hospital, Bangkok were analyzed. Patients who were not received neoadjuvant chemoradiation therapy, loss follow-up, incomplete data in the record, distant organ metastasis and who was not received colorectal surgery were excluded as study flow diagram. Age, sex, performance status, smoking, initial Hb level (g/mL), CEA level (ng/dL), distance of tumor from anal verge, diagnostic variables, clinical T staging, preoperative thickness and length from computer tomography scan (CT scan), organ metastasis before treatment, histology, treatment course, and outcomes after treatment were collected and analyzed.Total dose of radiation, interval time from CCRT to operation, and chemotherapy regimens were also collected between and after treatment. After preoperative CCRT, the radical rectal surgery was performed by eight experienced general surgeons and surgical oncologist using open and laparoscopic techniques. Perioperative data were collected and histology was evaluated by an experienced pathologists. For pathological classification, pathological responses were divided in 2 groups i.e., pathologic complete response (pCR group) and non-pCR group, (partial response, stable disease, and disease progression). Margin of lesions were classified as proximal, distal and circumferential margins. Lymph nodes status after surgery were specified as total lymph nodes harvested and positive lymph nodes.

A Cohort of Predictive Factor of Pathologic Complete Response After Preoperative Neoadjuvant in Rectum Cancer

Pathological of Tumor follow by The American Joint Committee on Cancer (AJCC) edition 8

Pathological of lymph node follow by The American Joint Committee on Cancer (AJCC) edition 8

Ramathibodi Hospital

Mahidol University

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Oxaliplatin

Neoadjuvant chemotherapy and chemoradiation

Chemoradiation

5-FU

Preoperative chemoradiation

Pelvic surgery

Neoadjuvant oxaliplatin

Georg Høyer, DH

Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Effect of treatment, safety profile and quality of life scorings.

Oxaliplatin and 5-FU Based Preoperative Chemoradiation

Oslo University Hospital

Senior consultant medical oncology

open rectal resection

laparoscopic rectal resection

Jae Hwan Oh, M.D., ph.D.

The investigators designed the randomized prospective trial of comparing open and laparoscopic resection in locally advanced rectal cancer after preoperative chemoradiation in order to determine the oncologic and functional efficacy of laparoscopic rectal resection.

1. Title: A comparison for laparoscopically assisted and open surgery for advanced rectal cancer after preoperative chemoradiation - randomized prospective trial
2. Principal investigator: Jae Hwan Oh Co-investigator: Seung Yong Jeong, Sung Bum Kang, Hyo Seong Choi, Seok-Byung Lim
3. Purpose of the study: To compare efficacy of laparoscopic and open resection for locally advanced rectal cancer after preoperative chemoradiation
4. Specific aims

   1. comparison of oncologic outcomes
   2. comparison of quality of life
   3. comparison of anorectal function
5. Materials Rectal cancer \<9cm from anal verge, measured by rigid sigmoidoscopy histologically proven adenocarcinoma locally advanced (T3), determined by CT, transrectal ultrasonography, MRI without any contraindication for general anesthesia,operation and chemoradiation Completion of preoperative chemoradiation
6. Statistics

   1. Sample size calculation for non-inferiority trial: 340
   2. Disease free survival: Log-rank test,Cox regression analysis
   3. QOL and anorectal function: Repeated measured ANCOVA
7. Methods

   1. operation time of operation : 6-8 weeks after end of preoperative chemoradiation surgical technique standard total mesorectal excision and high ligation of inferior mesenteric vessels
   2. preoperative chemoradiation chemotherapy: 2 cycles of 5-FU (400 mg/m2/day) + LV (20 mg/m2/day) IV bolus, for 3 days in 1st \& 5th wks of RT or Capecitabine 825 mg/m2 p.o. bid during RT RT:45 Gy/ 25 fractions to the pelvis, 5.4 Gy/ 3 fractions boost to the primary tumor over 5.5 wks
   3. postoperative chemotherapy 4 cycles of 5-FU (400 mg/m2/day) + LV (20 mg/m2/day) IV bolus, for 5 days, 4 wks interval
   4. oncologic outcomes

      1. Short-term outcomes Surgical length of incision op time blood loss intraoperative complications conversion rate Pathological resection margins (proximal, distal, circumferential) number of harvested lymph nodes length of resected bowel tumor regression grade (Dworak's grading) TNM staging Perioperative recovery duration of use of parenteral narcotics initiation of peristalsis initiation of oral intake duration of hospital stay 30-day postoperative mortality morbidity
      2. Long-term outcomes Primary end point Disease free survival (3 years after surgery) Secondary end points Overall survival Local recurrence Distant metastasis Port-site and wound site recurrence
   5. Quality of life Urinary function Duration of urinary catheterization Residual urine volume at discharge International Prostate Symptom Score (IPSS) Male sexual function International Index of Erectile Function (IIEF) Female sexual function Female Sexual Function Index (FSFI) QOL assessment EORTC QLQ C30 EORTC QLQ CR38
   6. Anorectal function Anorectal manometry Maximum Resting Pressure Maximum Squeezing Pressure High Pressure Zone Sphincter Length Sensory Threshold Rectal Capacity Rectal Compliance Rectoanal Inhibitory Reflex Fecal Incontinence Severity Index (FISI)

Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer

A Comparison for Laparoscopically Assisted and Open Surgery for Advanced Rectal Cancer After Preoperative Chemoradiation- Randomized Prospective Trial

National Cancer Center, Korea

Professor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Agents

Gemcitabine

Paclitaxel

Irinotecan

Albumin-Bound Paclitaxel

Pancrelipase

Pancreatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.

Systemic chemotherapy followed by chemoradiation, followed by definitive surgery

Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles

Gemcitabine and nanoparticle albumin bound paclitaxel

5-fluorouracil and irinotecan

Pre-operative chemoradiation to 40 Gy in 20 fractions

Definitive surgical resection of primary tumor

Definitive resection

Peter Kebbekus, MD, PhD

Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.

Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).

All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.

All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 \& 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.

After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.

Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.

Patients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.

Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla

Phase 2 Evaluation of a Community-Based Multi-modality Management Algorithm for Clinically Non-metastatic Ductal Adenocarcinoma of the Exocrine Pancreas or Ampulla

We will make unidentified dataset available for electronic download.

Percentage of patients alive and free of detectable disease 1 yr from start of treatment

Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection)

Time to death from any cause measured from start of treatment

Essentia Health

Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.

Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles

Definitive resection: Definitive surgical resection of primary tumor

Resectable, Low Risk

Systemic chemotherapy followed by chemoradiation, followed by definitive surgery

Gemcitabine and nanoparticle albumin bound paclitaxel: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles

5-fluorouracil and irinotecan: FOLFIRI.3 given every 14 days x 4 cycles

Preoperative chemoradiation: Pre-operative chemoradiation to 40 Gy in 20 fractions

Definitive resection: Definitive surgical resection of primary tumor

Locally Advanced

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Dr. Bret Friday

Due to excessive toxicity of study regimen, the study was permanently closed prior to data analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Cohort of Predictive Factor of Pathologic Complete Response After Preoperative Neoadjuvant in Rectum Cancer	NCT04443985	Rectum Cancer		18 Years -	Mahidol University
Oxaliplatin and 5-FU Based Preoperative Chemoradiation	NCT00278694	Rectal Cancer	Oxaliplatin Chemoradiation 5-FU Preoperative ch... Pelvic surgery Neoadjuvant oxa...	18 Years -	Oslo University Hospital
Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer	NCT00470951	Rectal Cancer	open rectal res... laparoscopic re...	18 Years - 80 Years	National Cancer Center, Korea
Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla	NCT02626520	Ductal Adenocar... Adenocarcinoma ...	Gemcitabine and... 5-fluorouracil ... Preoperative ch... Definitive rese...	18 Years - 85 Years	Essentia Health

Spots Global Cancer Trial Database for preoperative chemoradiation