Rectal CancerPhase 2NCT01923987
Short Course Radiotherapy Followed Intensive Chemotherapy With Delayed Surgery for Rectal Cancer With Synchronous Distant Metastasis
A Phase 2 study testing Short Course Radiotherapy, Chemotherapy and Delayed Surgery in people with Rectal Cancer and Liver Metastasis, run by Korea Cancer Center Hospital at 2 sites in South Korea.
Trial summary
Radical treatment of primary rectal cancer with synchronous distant metastases includes surgical resection of primary and metastatic lesion. However, primary rectal cancer in case of metastasized disease are often locally advanced disease and need downsizing before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Liver Metastasis, Lung Metastasis
- What is being tested?
- Short Course Radiotherapy, Chemotherapy and Delayed Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Aug 2012to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed adenocarcinoma of rectum
- Lower margin of tumor within 12 cm from anal verge
- Clinically locally advanced (T3-4 or N1-2) disease
- Potentially resectable and synchronous distant metastases in liver and/or lung. The resectability of metastatic lesions is determined by size, number, location, general condition, liver function, and lung function.
- Over 18 years
- Eastern Cooperative Oncology Group performance status 0-2
- Proper organ function (Hemoglobin ≥ 10 g/dl, Absolute neutrophil count (ANC) ≥ 1,500/mm3, Platelet ≥ 100,000/mm3, Creatinine ≤ 1.5 mg/dl, Clearance of creatinine >50 ml/min using Cockcroft-Gault formula, Bilirubin ≤ 1.5 x upper limit of normal (ULN), Liver enzyme (Aspartate aminotransferase/Alanine transaminase/Alkaline phosphatase) ≤ 2.5 x ULN)
- Subject who should sign on the informed consent form before participate the trial.
Who cannot join
- Metastases in other organ except liver or lung
- History of other type of malignancies within 3 years other than non-melanoma of the skin or carcinoma in situ of cervix
- Hereditary colorectal cancer (FAP, HNPCC, and etc)
- Bowel obstruction or impending bowel obstruction
- Uncontrolled severe illness, unsuitable to chemoradiotherapy (within 6 months, myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia, uncontrolled epilepsy, central nervous system disease, psychological disorder, and etc)
- Subject pregnant or breast feeding, or incapable of appropriate contraception
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- Unresected synchronous colorectal cancer
- History of prior pelvic radiotherapy
- History of prior chemotherapy for colorectal cancer
- Great surgery within 4 week before study enrollment
- Participant in other trial within 4 week before study enrollment
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 1 recruiting
- Active, not recruiting
Kyung Hee University Gangdong Hospital
Seoul, 134-727
- Recruiting
Korea Cancer Center Hospital
Seoul, 139-706
Sun Mi Moon, MD, PhD, 82-2-970-1237, msm386@yahoo.co.kr
Won Il Jang, MD, MS, 82-2-970-1262, zzang11@kirams.re.kr
About this study
Official title: Multicenter Phase II Study of Short Course Radiotherapy Followed by Intensive Chemotherapy With Delayed Surgery for Rectal Cancer With Synchronous Distant Metastasis
Radical treatment of primary rectal cancer with synchronous distant metastases includes surgical resection of primary and metastatic lesion. However, primary rectal cancer in case of metastasized disease are often locally advanced disease and need downsizing before surgery. It is reported that pelvic recurrence rates and distant metastasis rates outside liver are 30~35% and 60%, respectively. Therefore, combined treatment with radiotherapy and chemotherapy is used. However, the sequence of treatment modalities is not yet definitely established and preoperative chemoradiotherapy and surgical resection is accepted as an option of treatment. Conventional long course chemoradiotherapy delays administration of full-dose chemotherapy, and metastatic lesion can be progressed during chemoradiotherapy. In present study, we evaluate the efficacy of short course radiotherapy (SCRT) followed by full-dose chemotherapy with delayed surgical resection of the primary tumor and metastases.
- Conditions
- Rectal Cancer, Liver Metastasis, Lung Metastasis
- Being tested
- Short Course Radiotherapy, Chemotherapy, Delayed Surgery
- Keywords
- Short course radiotherapy, Modified FOLFOX6, Delayed surgery, Rectal cancer, Synchronous metastasis, Liver metastasis, Lung metastasis
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Course RadiotherapyRadiation
Also called Upfront Short-Course Radiotherapy
Radiotherapy to tumor and draining lymph node with 25 Gy in 5 fractions within 5 working days
ChemotherapyDrug
Also called FOLFOX or FOLFIRI (+-Bevacizumab or Cetuximab)
- Oxaliplatin 85 mg/m2 IV over 2 hrs on Day 1
- Irinotecan 180 mg/m2 IV over 30-90 mins on Day 1
- Leucovorin 400 mg/m2 IV over 2 hrs on Day 1 and 2
- 5-fluorouracil bolus 400 mg/m2 IV push on Day 1 and 2 (or 5-fluorouracil infusion 600 mg/m2 IV continuous infusion over 22 hrs).
- Bevacizumab 5 mg/kg IV over 90 mins on Day 1
- Cetuximab (only for patients with K-ras wild type and positive EGFR mutation) 400 mg/m2 IV over 2 hrs on Day 1, and 250 mg/m2 IV over 1 hr on Day 8, 15, 22, 29, and 36.
- FOLFOX or FOLFIRI (+-Bevacizumab ) repeats every 14 days for up to 3 courses. Cetuximab repeats every week for up to 6 courses
- Postoperative FOLFOX or FOLFIRI (+-Bevacizumab or Cetuximab) for up to 9 cycles (total 12 cycles)
Delayed SurgeryProcedure or surgery
Also called Total (or Tumor-specific) mesorectal excision
If primary tumor and metastases is resectable after FOLFOX or FOLFIRI (+-Bevacizumab or Cetuximab) of 3 cycles, patients have surgical resection (and/or radiofrequency ablation to metastases).
| Study group | Role | What they receive |
|---|---|---|
| SCRT/ChemoTx with Delayed Surgery | Experimental | Short course radiotherapy (25 Gy in 5 fractions) followed by intensive chemotherapy, compromising of FOLFOX of FOLFIRI (+-Bevacizumab or Cetuximab), with delayed surgery for rectal cancer with synchronous distant metastasis Receives: Radiation: Short Course Radiotherapy; Drug: Chemotherapy; Procedure: Delayed Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
R0 resection rate of primary and metastatic lesions
Measured: Expected average of 12 weeks (after resection)
Secondary outcomes (4)
Overall survival rate
From the first date of radiotherapy to the date of death or last follow-up
Measured: 2 years
Progression free survival rate
From the first date of radiotherapy to the date of first failure or last follow-up
Measured: 2 years
Tumor regression grade
Tumor regression grade of primary lesion
Measured: Just after resection & pathologic report
Toxicity
Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Cancer Center Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong, Gachon University Gil Medical Center, Catholic University of Korea, Yeouido St. Mary's Hospital, Pusan National University Yangsan Hospital, Gangnam Severance Hospital, Severance Hospital, Wonju Severance Christian Hospital, Chungnam National University Hospital, Dongtan Sacred Heart Hospital, The Koreran Society of Coloproctology, The Catholic University of Korea
- Responsible party
- Principal investigator, Sun Mi Moon, Korea Cancer Center Hospital
- Investigators
- Sun Mi Moon, MD, PhD, Principal investigator, Korea Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923987
- Sponsor's protocol ID
- K-1208-001-002
- Other IDs
- KCT0000525, K-1208-001-002
- Status last verified
- Sep 2019
- First submitted
- 7 Aug 2013
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study of Short Course Radiotherapy Followed by Intensive Chemotherapy With Delayed Surgery for Rectal Cancer With Synchronous Distant Metastasis
- ClinicalTrials.gov ID
- NCT01923987
- Acronym / sponsor ID
- K-1208-001-002
- Conditions
- Rectal Cancer, Liver Metastasis, Lung Metastasis
- Keywords
- Short course radiotherapy, Modified FOLFOX6, Delayed surgery, Rectal cancer, Synchronous metastasis, Liver metastasis, Lung metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Korea Cancer Center HospitalUniversity, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong, Gachon University Gil Medical Center, Catholic University of Korea, Yeouido St. Mary's Hospital, Pusan National University Yangsan Hospital, Gangnam Severance Hospital, Severance Hospital, Wonju Severance Christian Hospital, Chungnam National University Hospital, Dongtan Sacred Heart Hospital, The Koreran Society of Coloproctology, The Catholic University of Korea
- Study start
- Aug 2012
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radical treatment of primary rectal cancer with synchronous distant metastases includes surgical resection of primary and metastatic lesion. However, primary rectal cancer in case of metastasized disease are often locally advanced disease and need downsizing before surgery. It is reported that pelvic recurrence rates and distant metastasis rates outside liver are 30~35% and 60%, respectively. Therefore, combined treatment with radiotherapy and chemotherapy is used. However, the sequence of treatment modalities is not yet definitely established and preoperative chemoradiotherapy and surgical resection is accepted as an option of treatment. Conventional long course chemoradiotherapy delays administration of full-dose chemotherapy, and metastatic lesion can be progressed during chemoradiotherapy. In present study, we evaluate the efficacy of short course radiotherapy (SCRT) followed by full-dose chemotherapy with delayed surgical resection of the primary tumor and metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCRT/ChemoTx with Delayed Surgery | Experimental | Radiation: Short Course Radiotherapy, Drug: Chemotherapy, Procedure: Delayed SurgeryShort course radiotherapy (25 Gy in 5 fractions) followed by intensive chemotherapy, compromising of FOLFOX of FOLFIRI (+-Bevacizumab or Cetuximab), with delayed surgery for rectal cancer with synchronous distant metastasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically confirmed adenocarcinoma of rectum
- Lower margin of tumor within 12 cm from anal verge
- Clinically locally advanced (T3-4 or N1-2) disease
- Potentially resectable and synchronous distant metastases in liver and/or lung. The resectability of metastatic lesions is determined by size, number, location, general condition, liver function, and lung function.
- Over 18 years
Key exclusion criteria (11 listed)
- Metastases in other organ except liver or lung
- History of other type of malignancies within 3 years other than non-melanoma of the skin or carcinoma in situ of cervix
- Hereditary colorectal cancer (FAP, HNPCC, and etc)
- Bowel obstruction or impending bowel obstruction
- Uncontrolled severe illness, unsuitable to chemoradiotherapy (within 6 months, myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia, uncontrolled epilepsy, central nervous system disease, psychological disorder, and etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Course RadiotherapyAlso: Upfront Short-Course RadiotherapyRadiotherapy to tumor and draining lymph node with 25 Gy in 5 fractions within 5 working days | Radiation | SCRT/ChemoTx with Delayed Surgery |
| ChemotherapyAlso: FOLFOX or FOLFIRI (+-Bevacizumab or Cetuximab)* Oxaliplatin 85 mg/m2 IV over 2 hrs on Day 1 * Irinotecan 180 mg/m2 IV over 30-90 mins on Day 1 * Leucovorin 400 mg/m2 IV over 2 hrs on Day 1 and 2 * 5-fluorouracil bolus 400 mg/m2 IV push on Day 1 and 2 (or 5-fluorouracil infusion 600 mg/m2 IV continuous infusion over 22 hrs). * Bevacizumab 5 mg/kg IV over 90 mins on Day 1 * Cetuximab (only for patients with K-ras wild type and positive EGFR mutation) 400 mg/m2 IV over 2 hrs on Day 1, and 250 mg/m2 IV over 1 hr on Day 8, 15, 22, 29, and 36. * FOLFOX or FOLFIRI (+-Bevacizumab ) repeats every 14 days for up to 3 courses. Cetuximab repeats every week for up to 6 courses * Postoperative FOLFOX or FOLFIRI (+-Bevacizumab or Cetuximab) for up to 9 cycles (total 12 cycles) | Drug | SCRT/ChemoTx with Delayed Surgery |
| Delayed SurgeryAlso: Total (or Tumor-specific) mesorectal excisionIf primary tumor and metastases is resectable after FOLFOX or FOLFIRI (+-Bevacizumab or Cetuximab) of 3 cycles, patients have surgical resection (and/or radiofrequency ablation to metastases). | Procedure or surgery | SCRT/ChemoTx with Delayed Surgery |
Primary outcome
R0 resection rate
Time frame: Expected average of 12 weeks (after resection)
R0 resection rate of primary and metastatic lesions
4 secondary outcomes
Overall survival rate
Time frame: 2 years
Progression free survival rate
Time frame: 2 years
Tumor regression grade
Time frame: Just after resection & pathologic report
Toxicity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Mi Moon, MD, PhD principal investigator
Korea Cancer Center Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short Course Radiotherapy, Chemotherapy and Delayed Surgery in people with Rectal Cancer and Liver Metastasis, run by Korea Cancer Center Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Mi Moon, MD, PhD (82-2-970-1237, msm386@yahoo.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: Expected average of 12 weeks (after resection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.