Preoperative Chemoradiation Followed by Chemotherapy for Locally Advanced Rectal Cancer (PREPARE)
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ClinicalTrials.gov Identifier: NCT01952951 |
Recruitment Status : Unknown
Verified September 2017 by Sun Young Kim, National Cancer Center, Korea.
Recruitment status was: Active, not recruiting
First Posted : September 30, 2013
Last Update Posted : September 13, 2017
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Condition or disease | Intervention/treatment | Phase |
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Rectal Neoplasms Adenocarcinoma | Drug: Capecitabine Oxaliplatin Radiation: pelvic radiation capecitabine 5-fluorouracil | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase II Trial of Preoperative Chemoradiation (Preop CRT) Followed by CapOx (Capecitabine Plus Oxaliplatin) Versus Preop CRT Alone for Locally Advanced Rectal Cancer (LARC) |
Study Start Date : | June 2014 |
Actual Primary Completion Date : | September 2017 |
Estimated Study Completion Date : | December 2019 |
Arm | Intervention/treatment |
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Experimental: 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)
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Drug: 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.
Other Names:
Radiation: pelvic radiation capecitabine 5-fluorouracil 50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil
Other Names:
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Active Comparator: 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)
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Radiation: pelvic radiation capecitabine 5-fluorouracil
50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil
Other Names:
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- downstaging rate [ Time Frame: expected average of 15 weeks after start of study treatment ]downstaging rate is defined as the proportion of patients with ypStage (pathologic stage after preoperative treatment) 0 or I (from pathologic findings after preoperative treatment and surgery) out of all patients who were assigned to each arm.
- pathologic response [ Time Frame: expected average of 15 weeks after start of study treatment ]pathologic response is assessed by Dworak's grading system from postoperative specimen.
- radiologic response rate [ Time Frame: expected average of 14 weeks after start of study treatment ]radiologic response will be assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline 1.1
- toxicity profile [ Time Frame: expected average of 35 weeks after start of study treatment ]Toxicities or any adverse events during study treatment, surgery and follow-up period will be assessed according to NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.0
- pattern of failure [ Time Frame: 3 years after surgery ]if any recurrent lesion is noticed, anatomic sites of recurrent lesions and the date and the name of exam or imaging study (physical exam, CT or MRI…) will be recorded in case report form.
- local control rate [ Time Frame: 3 years after surgery ]Local recurrence is defined as tumor recurrence confined in radiation field (pelvic cavity). Cumulative incidence of local recurrence will be suggested.
- relapse-free survival [ Time Frame: 3 years after surgery ]Time from date of operation to date of recurrence of disease or deaths due to recurrence or progression of disease.
- Disease-free survival [ Time Frame: 3 years after surgery ]time from date of operation to date of recurrence of disease, a new occurrence of secondary colorectal cancer, a new occurrence of other malignancy, or deaths from any cause.
- overall survival [ Time Frame: 3 years after surgery ]time from date of operation to date of death due to any cause.
- quality of life [ Time Frame: before study treatment, 7 weeks after completion of chemoradiation, and at 4 weeks after surgery ]quality of life will be measured with FACT-C
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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952951
Korea, Republic of | |
National Cancer Center | |
Goyang, Gyeonggi-do, Korea, Republic of, 410-769 | |
Seoul National University Bundang Hospital | |
Seongnam, Gyeonggi-do, Korea, Republic of, 13620 | |
Hallym University Sacred Heart Hospital | |
Anyang, Korea, Republic of | |
Gangneung Asan Hospital | |
Gangneung, Korea, Republic of | |
Severance Hospital | |
Seoul, Korea, Republic of, 03722 | |
Asan Medical Center | |
Seoul, Korea, Republic of, 05505 | |
Chung-Ang University Hospital | |
Seoul, Korea, Republic of, 06973 |
Study Chair: | Sun Young Kim, MD | Asan Medical Center |
Responsible Party: | Sun Young Kim, MD, National Cancer Center, Korea |
ClinicalTrials.gov Identifier: | NCT01952951 |
Other Study ID Numbers: |
KCSG CO14-03 |
First Posted: | September 30, 2013 Key Record Dates |
Last Update Posted: | September 13, 2017 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
rectal neoplasms radiotherapy Antineoplastic Agents |
Rectal Neoplasms Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
Capecitabine Fluorouracil Oxaliplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |