Neoadjuvant Chemotherapy in Patients With Moderate Risk Mid Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether 3 months of neoadjuvant CapOx is non-inferior to neoadjuvant radiotherapy in patients with moderate risk CRM"-" mid rectal cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neoadjuvant Chemotherapy in Patients With Intermediate Risk Upper and Mid Rectal Cancer

NCT04103697

Rectal Neoplasms Malignant Rectum Carcinoma Rectal Cancer

UNKNOWN PHASE3

Induction and Consolidation Chemotherapy in Patients With Locally Advanced CRM-positive Rectal Cancer

NCT04135313

Rectal Neoplasms Malignant Rectum Carcinoma Rectal Cancer

UNKNOWN PHASE3

NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer

NCT03280407

Colorectal Neoplasm Colorectal Cancer Rectal Neoplasms +4 more

UNKNOWN PHASE2

Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer

NCT00081289

Colorectal Cancer

COMPLETED PHASE2

Capecitabine and Oxaliplatin or Standard Follow-Up Care in Treating Patients Who Have Undergone Surgery for Locally Advanced Rectal Cancer

NCT00427713

Colorectal Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This trial aims to investigate the efficacy of neoadjuvant chemotherapy compared to 5x5 Gy neoadjuvant radiotherapy in moderate risk CRM-negative rectal cancer patients. This is a prospective multicenter open-label non-inferiority randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either 4 cycles of neoadjuvant CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, surgery and 4 cycles of adjuvant CapOx chemotherapy or 5x5 Gy radiotherapy, surgery and 8 cycles of adjuvant CapOx chemotherapy. A stratification will be performed based on сN stage and clinical center. Patients with сT3c-T3dN0-1M0, cT1-T3dN2M0 cancer in the middle rectum are included. Chemoradiotherapy (50 Gy with concomitant capecitabine 825 mg/m2 per os bid on radiation days) will be performed for patients with tumor progression after neoadjuvant chemotherapy. The main hypothesis is that the 2-year local recurrence rate is non-inferior after neoadjuvant chemotherapy and neoadjuvant radiotherapy in moderate risk mid rectal cancer patients. The target accrual is 158 patients in each treatment arm (including 10% potential data loss) based on non-recurrence rate of 98% in investigated and 96% in the control group with a non-inferiority margin of 3%, α=0,05, power 80%. An interim analysis is planned after 50% of the patients will reach a 2-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging before and after neoadjuvant chemotherapy and before surgery. Pelvic MRI is subject to central review. Conduction of this study and data collection are controlled by a local institutional board.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Neoplasms Malignant Rectum Carcinoma Rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neoadjuvant chemotherapy

Patients will receive 4 cycles of neoadjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks). In case of partial response or stable disease (based on pelvic MRI) patients proceed to surgery within 2 weeks. In case of disease progression patients receive 50 Gy pelvic chemoradiotherapy with capecitabine 825 mg/m2 bid per os on radiation days and then surgery following 8-10 weeks. After surgery patients receive 4 cycles of adjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks).

Group Type EXPERIMENTAL

Capecitabine

Intervention Type DRUG

2000 mg/m2, bid, per os, days 1-14, 4 cycles

Oxaliplatin

Intervention Type DRUG

130 mg/m2 iv day 1, 4 cycles

Capecitabine

Intervention Type DRUG

825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)

Radiotherapy

Intervention Type RADIATION

Pelvic radiotherapy dose: 44 Gy on regional nodes, 50 Gy on primary tumor

Rectal cancer surgery

Intervention Type PROCEDURE

Laparoscopic or open total mesorectal excision

Neoadjuvant radiotherapy

Patients will receive 5x5 Gy radiotherapy and then surgery following 6-8 weeks. After surgery patients receive 8 cycles of adjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks).

Group Type ACTIVE_COMPARATOR

Capecitabine

Intervention Type DRUG

2000 mg/m2, bid, per os, days 1-14, 4 cycles

Oxaliplatin

Intervention Type DRUG

130 mg/m2 iv day 1, 4 cycles

Rectal cancer surgery

Intervention Type PROCEDURE

Laparoscopic or open total mesorectal excision

Radiotherapy

Intervention Type RADIATION

Pelvic radiotherapy dose: 25 Gy in 5 Gy fractions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Capecitabine

2000 mg/m2, bid, per os, days 1-14, 4 cycles

Intervention Type DRUG

Oxaliplatin

130 mg/m2 iv day 1, 4 cycles

Intervention Type DRUG

Capecitabine

825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)

Intervention Type DRUG

Radiotherapy

Pelvic radiotherapy dose: 44 Gy on regional nodes, 50 Gy on primary tumor

Intervention Type RADIATION

Rectal cancer surgery

Laparoscopic or open total mesorectal excision

Intervention Type PROCEDURE

Radiotherapy

Pelvic radiotherapy dose: 25 Gy in 5 Gy fractions

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Xeloda Xeloda

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Informed consent
* Histologically verified colon rectal adenocarcinoma
* сT3c-T3dN0-1M0, cT1-T3dN2M0. cancer of the middle rectum (based on pelvic MRI)
* Tumor more than 2 mm from mesorectal fascia (based on pelvic MRI)
* Eastern Cooperative Oncology Group (ECOG) status 0-2
* Haemoglobin (HGB) \> 90 g/L
* Platelet Count (PLT) \> 120x10\*9/L
* Serum creatinine \< 150 µmol/L
* Total bilirubin \< 25 µmol/L

Exclusion Criteria

* inability to obtain informed consent
* distant metastases
* synchronous or metachronous tumors
* previous chemotherapy or radiotherapy
* clinically significant cardiovascular disorders (myocardial infarction \< 6 months before visit, stroke \< \< 6 months before visit, instable angina \< 3 months before visit, arrhythmia, uncontrolled hypertension \> 160/100 mm hg
* clinically significant neurological disorders
* previous neuropathy 2 or higher
* current infection or heavy systemic disease
* pregnancy, breastfeeding
* ulcerative colitis
* individual intolerance to treatment components
* proven dihydropyrimidine dehydrogenase (DPD) deficiency
* participation in other clinical trials
* psychiatric disorders, which render patient unable to follow instructions or understand his/her condition
* technical inability to perform pelvic MRI
* inability of long-term followup of the patient
* HIV

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No