Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced 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

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-12-31

Brief Summary

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

The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence. This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.

Related Clinical Trials

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

Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer

NCT01129700

Rectal Cancer

COMPLETED PHASE2

Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC

NCT03156036

Advanced Rectal Cancer

COMPLETED PHASE2

Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer

NCT01186081

Rectal Cancer

COMPLETED PHASE3

Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study

NCT05998122

Locally Advanced Rectal Cancer Total Neoadjuvant Treatment Anti-PD-1

NOT_YET_RECRUITING PHASE2

Neoadjuvant Treatment for Advanced Rectal Carcinoma

NCT02551237

Rectal Carcinoma

COMPLETED PHASE3

Detailed Description

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

Downstaging rate with CRT using fluoropyrimidine monotherapy is usually 30-40%.In MRI-defined high-risk patients, downstaging rate with conventional fluoropyrimidine-based monotherapy with radiation has not been shown. We assume that the downstaging rate of chemoradiation arm (control arm) would be 30%, and that addition of CapOx after CRT (experimental arm) may increase downstaging rate 30% to 50%. A sample size of 52 patients per group is needed have 85% power to detect downstaging rate = 50% as compared to 30% with type I error rate of 15%. We will perform one interim futility analysis when half of the patients are recruited and evaluated for the primary endpoint. O'Brien-Fleming boundary will be considered. Therefore, when 26 patients per arm are evaluated, the interim futility analysis will be performed, and when the Z score at the interim is less than -0.09192 (one-sided p-value greater than 0.5366192), the study will be stopped for futility. Considering 5% follow-up loss, a sample size of 55 per arm (a total of 110 patients) will be studied.

Conditions

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

Rectal Neoplasms Adenocarcinoma

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.

chemoradiation followed by CapOx

preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by 2 cycles of chemotherapy (Capecitabine Oxaliplatin - CapOx) and surgery (total mesorectal excision)

Group Type EXPERIMENTAL

Capecitabine Oxaliplatin

Intervention Type DRUG

after completion of chemoradiation, two cycles of capecitabine (850mg/m2 twice daily from D1 evening to D15 morning) and oxaliplatin (100mg/m2 on D1) will be administered every 3 weeks.

pelvic radiation capecitabine 5-fluorouracil

Intervention Type RADIATION

50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil

chemoradiation

preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by rest for 8 weeks and surgery (total mesorectal excision)

Group Type ACTIVE_COMPARATOR

pelvic radiation capecitabine 5-fluorouracil

Intervention Type RADIATION

50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil

Interventions

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

Capecitabine Oxaliplatin

after completion of chemoradiation, two cycles of capecitabine (850mg/m2 twice daily from D1 evening to D15 morning) and oxaliplatin (100mg/m2 on D1) will be administered every 3 weeks.

Intervention Type DRUG

pelvic radiation capecitabine 5-fluorouracil

50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil

Intervention Type RADIATION

Other Intervention Names

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

Xeloda Oxalitin preoperative chemoradiation xeloda

Eligibility Criteria

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

Inclusion Criteria

* histologically confirmed adenocarcinoma of the rectum
* distal margin of tumor located from 0 to 12 cm from anal verge measured by digital rectal examination
* high risk clinical stage II or III in MRI (satisfying at least one of the followings)

* circumferential resection margin \< 1 mm involved
* low-lying tumor below anal verge 3 cm
* T3 \> 5 mm extramural spread
* T4 (involving surrounding structures or peritoneum)
* cN2 (4 or more mixed signal intensity or irregularly bordered node or tumor deposit)
* age 20 years or more
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* No prior chemotherapy, radiotherapy to pelvis
* Adequate bone marrow function
* Adequate renal function
* Adequate hepatic function
* patients must sign the informed consent indicating that they were aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria

* malignant disease of the rectum other than adenocarcinoma or arisen from chronic inflammatory bowel disease
* any unresected synchronous colon cancer
* any distant metastases
* intestinal obstruction or impending obstruction, but decompressing colostomy is permitted
* any previous or concurrent malignancy withih 5 years other than non-melanoma skin cancer / in situ cancer of uterine cervix / early gastric cancer / thyroid cancer of low risk
* any other morbidity or situation with relative contraindication for chemoradiotherapy
* patients with history of significant gastric or small bowel resection, or malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may compromise the absorption of capecitabine
* pregnant or lactating women or patients of childbearing potential not predicting adequate contraception

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No