Advanced Rectal CancerPhase 2NCT03156036
Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC
A Phase 2 study testing Capecitabine plus temozolomide VS Capecitabine in people with Advanced Rectal Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This is a prospective biomarker-stratified, randomised phase II study of preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer. The primary endpoint is pathologic complete response rates defined as total regression of the primary tumor. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Rectal Cancer
- What is being tested?
- Capecitabine plus temozolomide VS Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2017to 2 Feb 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for inclusion, each patient must fulfill each of the following criteria:
- Histologically confirmed adenocarcinoma of the rectum
- Tumor located within 12cm of anal verge
- Clinical stage of cT3-4Nany (cStage II) or cTanyN1-2 (cStage III) by rectal MRI
- Available tumor samples for methylation-specific PCR (MSP) to investigate MGMT hypermethylation
- Male or female aged over 20 years
Show all 12Show fewer
- Be ambulatory and have an Eastern Cooperative Oncology Group (ECOG) performance status0-1.
- No prior systemic treatment (chemotherapy, immunotherapy) or radiation therapy
- Adequate major organ functions as following:
- Hematopoietic function: ANC 1,500/mm3, Platelet 100,000/mm3 Hepatic function: serum bilirubin 2.0 mg/dL, AST/ALT levels 2.5 x UNL Renal function: serum creatinine UNL or Cockroft creatinine clearance 50 ml/min
- Be willing and able to comply with the protocol for the duration of the study.
- Give written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Who cannot join
- Patients will be exluded from the study for any of the following reasons:
- Histology other than adenocarcinoma or tumor arising from inflammatory bowel disease
- Inadequate tumor sample for MGMT MSP
- Any evidence of systemic metastasis
- Unresected synchronous colon cancer; endoscopically resected synchronous colon cancer of pTis or pT1 is permitted
- Subjects unable to swallow oral medication because of such as current or impending intestinal obstructions, but bypass surgery (colostomy or ileostomy) is permitted before study treatment
Show all 18Show fewer
- Uncontrolled or severe cardiovascular disease:
- New York Heart Association class III or IV heart disease.
- Unstable angina or myocardial infarction within the past 6 months.
- History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality.
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
- Other malignancy within the past 5 years except cured non-melanomatous skin cancer, carcinoma in situ of the cervix, or thyroid papillary carcinoma.
- Organ allografts requiring immunosuppressive therapy.
- Psychiatric disorder or uncontrolled seizure that would preclude compliance.
- Pregnant, nursing women or patients with reproductive potential without contraception.
- Patients receiving a concomitant treatment with drugs interacting with 5-FU such as flucytosine, phenytoin, or warfarin et al.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Known hypersensitivity to any of the components of the study medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Chemoradiotherapy With Capecitabine With or Without Temozolomide in Patients With Locally Advanced Rectal Cancer; A Prospective Randomised Phase 2 Study Stratified by MGMT (O6-methylguanine DNA Methyltransferase) Status
This is a prospective biomarker-stratified, randomised phase II study of preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer.
The primary endpoint is pathologic complete response rates defined as total regression of the primary tumor.
For each cohort of MGMT hypermethylated versus MGMT unmethylated, patients will be randomised (ratio 1:1 for each arm) into preoperative CRT with capecitabine or preoperative CRT with temozolomide plus capecitabine arms. According to the prior phase I results, MGMT hypermethylated arm is estimated as 70% of total patients and the target pathologic complete response rate was assumed as 35% in this population when treated with preoperative CRT with temozolomide and capecitabine (15% in the standard treatment arm or those with unmethylated MGMT). Investigator would like to demonstrate the superiority in terms of pathologic complete responses when treated with preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer, and to validate the predictive role of MGMT status
Read the detailed description
Preoperative chemoradiation (CRT) with fluoropyrimidine (5-fluorouracil or capecitabine) is now regarded as a standard treatment option in patients with locally advanced resectable rectal cancer and pathologic response rates and tumor regression grades after preoperative CRT have been proved to be important prognostic factors for survival outcomes.
Several studies of preoperative CRT with fluoropyrimidines plus other agents, such as oxaliplatin, irinotecan, cetuximab, and bevacizumab, have been performed to improve pathologic response rates; however, they have failed to show improved results compared to those with fluoropyrimidine alone.
Thus fluoropyrimidine alone is a standard chemotherapeutic strategy in patients with locally advanced resectable rectal cancer who will be treated with preoperative CRT at present.
Temozolomide is an oral alkylating agent, and has been proved to be effective in patients with glioblastoma or high grade anaplastic glioma when administered with concurrent radiotherapy either as adjuvant or recurrent settings.
Temozolomide has been known to deplete O6-methylguanine DNA methyltransferase (MGMT), which is one of the DNA repair enzymes, and recent studies have shown that MGMT gene silencing (lower expression by immunohistochemistry or hypermethylation by methylation-specific PCR) played a predictive marker of better responses to CRT with temozolomide in patient with glioblastoma and high grade anaplastic glioma.
Silencing of MGMT by promoter hypermethylation has been known to involve colorectal carcinogenesis pathway by the association with KRAS mutation and low-CIMP (CpG island methylation phenotype), and microsatellite instability. There have been suggestions that MGMT promoter hypermethylation played a role as a predictive factor of low recurrence in colorectal cancer patients with adjuvant oral fluoropyrimidine chemotherapy after curative surgery, and also as a predictive factor for treatment response from temozolomide in patients with metastatic colorectal cancer.
Therefore, combination chemotherapy of temozolomide plus capecitabine for rectal cancer patients when treated with preoperative CRT is worthy of investigated especially in those harbouring silenced MGMT gene as following reasons;
- the role of temozolomide has been well established,
- MGMT gene silencing is associated with colorectal carcinogenesis and might act as a predictive biomarker; and
- the addition of temozolomide can be synergistic during preoperative CRT with capecitabine for rectal cancer patients.
Investigator have performed a phase I study of preoperative CRT with temozolomide plus capecitabine in patient with locally advanced rectal cancer, and the results of this study has been published The recommended dose of temozolomide was determined as 75 mg/m2 once daily when combined with standard preoperative CRT with capecitabine, there was no grade 4 adverse events and the treatment was generally well tolerated. MGMT hypermethylation was found in 72% of rectal cancer patients (16/22), and the pathologic complete responses rates were 37.5% (6/16) in patient harbouring hypermethylated MGMT versus 16.7% in those with unmethylated MGMT.
On the basis of prior trial results, Investigator concluded that preoperative CRT with temozolomide plus capecitabine is well tolerated without any notable adverse event, and is worthy of investigation especially in those harbouring MGMT gene silencing.
Investigator planned a prospective, biomarker-stratified, randomised phase II study of preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer to demonstrate the addition of temozolomide in the conventional preoperative CRT might enhance the pathologic responses in those harbouring hypermethylated MGMT.
- Conditions
- Advanced Rectal Cancer
- Being tested
- Capecitabine plus temozolomide VS Capecitabine
- Keywords
- Temozolomide, Capecitabine, MGMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine plus temozolomide VS CapecitabineDrug
Also called Temoram, Xeloda
For each cohort of MGMT hypermethylated versus MGMT unmethylated, patients will be randomised (ratio 1:1 for each arm) into preoperative CRT with capecitabine or preoperative CRT with temozolomide plus capecitabine arms.
Chemotherapy during preoperative chemoradiotherapy:
Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).
dosage: Capecitabine 825 mg/m2 twice daily, Temozolomide 75 mg/m2/day
| Study group | Role | What they receive |
|---|---|---|
| MGMT hypermethylated Cohort A | Experimental | MGMT hypermethylated Cohort A patients will be randomised into preoperative CRT with temozolomide plus capecitabine arms. (n=86) Receives: Drug: Capecitabine plus temozolomide VS Capecitabine |
| MGMT hypermethylated Cohort B | Active comparator | MGMT hypermethylated B Cohort patients will be randomised into preoperative CRT with capecitabine arms. (n=86) Receives: Drug: Capecitabine plus temozolomide VS Capecitabine |
| MGMT unmethylated Cohort A | Active comparator | MGMT unmethylated A patients will be randomised into preoperative CRT with temozolomide plus capecitabine arms. (n=37) Receives: Drug: Capecitabine plus temozolomide VS Capecitabine |
| MGMT unmethylated Cohort B | Active comparator | MGMT unmethylated B patients will be randomised into preoperative CRT with capecitabine arms.
(n=37) Receives: Drug: Capecitabine plus temozolomide VS Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response rate(Pathologic staging and tumor regression grade.)
Surgery is after the completion of CRT
Measured: 6 weeks(maximum 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start30 Nov 2017
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Sang Hong, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156036
- Sponsor's protocol ID
- TemoCap2
- Status last verified
- Sep 2023
- First submitted
- 3 May 2017
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oh CR, Kim JE, Lee JS, Kim SY, Kim TW, Choi J, Kim J, Park IJ, Lim SB, Park JH, Kim JH, Choi MK, Cha Y, Baek JY, Beom SH, Hong YS. Preoperative Chemoradiotherapy With Capecitabine With or Without Temozolomide in Patients With Locally Advanced Rectal Cancer: A Prospective, Randomised Phase II Study Stratified by O6-Methylguanine DNA Methyltransferase Status: KCSG-CO17-02. Clin Oncol (R Coll Radiol). 2023 Feb;35(2):e143-e152. doi: 10.1016/j.clon.2022.10.016. Epub 2022 Nov 12.
PubMed 36376167
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Chemoradiotherapy With Capecitabine With or Without Temozolomide in Patients With Locally Advanced Rectal Cancer; A Prospective Randomised Phase 2 Study Stratified by MGMT (O6-methylguanine DNA Methyltransferase) Status
- ClinicalTrials.gov ID
- NCT03156036
- Acronym / sponsor ID
- TemoCap2
- Conditions
- Advanced Rectal Cancer
- Keywords
- Temozolomide, Capecitabine, MGMT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 17 May 2017 (actual)
- 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.
This is a prospective biomarker-stratified, randomised phase II study of preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer.
The primary endpoint is pathologic complete response rates defined as total regression of the primary tumor.
For each cohort of MGMT hypermethylated versus MGMT unmethylated, patients will be randomised (ratio 1:1 for each arm) into preoperative CRT with capecitabine or preoperative CRT with temozolomide plus capecitabine arms. According to the prior phase I results, MGMT hypermethylated arm is estimated as 70% of total patients and the target pathologic complete response rate was assumed as 35% in this population when treated with preoperative CRT with temozolomide and capecitabine (15% in the standard treatment arm or those with unmethylated MGMT). Investigator would like to demonstrate the superiority in terms of pathologic complete responses when treated with preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer, and to validate the predictive role of MGMT status
Detailed description
Preoperative chemoradiation (CRT) with fluoropyrimidine (5-fluorouracil or capecitabine) is now regarded as a standard treatment option in patients with locally advanced resectable rectal cancer and pathologic response rates and tumor regression grades after preoperative CRT have been proved to be important prognostic factors for survival outcomes.
Several studies of preoperative CRT with fluoropyrimidines plus other agents, such as oxaliplatin, irinotecan, cetuximab, and bevacizumab, have been performed to improve pathologic response rates; however, they have failed to show improved results compared to those with fluoropyrimidine alone.
Thus fluoropyrimidine alone is a standard chemotherapeutic strategy in patients with locally advanced resectable rectal cancer who will be treated with preoperative CRT at present.
Temozolomide is an oral alkylating agent, and has been proved to be effective in patients with glioblastoma or high grade anaplastic glioma when administered with concurrent radiotherapy either as adjuvant or recurrent settings.
Temozolomide has been known to deplete O6-methylguanine DNA methyltransferase (MGMT), which is one of the DNA repair enzymes, and recent studies have shown that MGMT gene silencing (lower expression by immunohistochemistry or hypermethylation by methylation-specific PCR) played a predictive marker of better responses to CRT with temozolomide in patient with glioblastoma and high grade anaplastic glioma.
Silencing of MGMT by promoter hypermethylation has been known to involve colorectal carcinogenesis pathway by the association with KRAS mutation and low-CIMP (CpG island methylation phenotype), and microsatellite instability. There have been suggestions that MGMT promoter hypermethylation played a role as a predictive factor of low recurrence in colorectal cancer patients with adjuvant oral fluoropyrimidine chemotherapy after curative surgery, and also as a predictive factor for treatment response from temozolomide in patients with metastatic colorectal cancer.
Therefore, combination chemotherapy of temozolomide plus capecitabine for rectal cancer patients when treated with preoperative CRT is worthy of investigated especially in those harbouring silenced MGMT gene as following reasons;
- the role of temozolomide has been well established,
- MGMT gene silencing is associated with colorectal carcinogenesis and might act as a predictive biomarker; and
- the addition of temozolomide can be synergistic during preoperative CRT with capecitabine for rectal cancer patients.
Investigator have performed a phase I study of preoperative CRT with temozolomide plus capecitabine in patient with locally advanced rectal cancer, and the results of this study has been published The recommended dose of temozolomide was determined as 75 mg/m2 once daily when combined with standard preoperative CRT with capecitabine, there was no grade 4 adverse events and the treatment was generally well tolerated. MGMT hypermethylation was found in 72% of rectal cancer patients (16/22), and the pathologic complete responses rates were 37.5% (6/16) in patient harbouring hypermethylated MGMT versus 16.7% in those with unmethylated MGMT.
On the basis of prior trial results, Investigator concluded that preoperative CRT with temozolomide plus capecitabine is well tolerated without any notable adverse event, and is worthy of investigation especially in those harbouring MGMT gene silencing.
Investigator planned a prospective, biomarker-stratified, randomised phase II study of preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer to demonstrate the addition of temozolomide in the conventional preoperative CRT might enhance the pathologic responses in those harbouring hypermethylated MGMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MGMT hypermethylated Cohort A | Experimental | Drug: Capecitabine plus temozolomide VS CapecitabineMGMT hypermethylated Cohort A patients will be randomised into preoperative CRT with temozolomide plus capecitabine arms. (n=86) |
| MGMT hypermethylated Cohort B | Active comparator | Drug: Capecitabine plus temozolomide VS CapecitabineMGMT hypermethylated B Cohort patients will be randomised into preoperative CRT with capecitabine arms. (n=86) |
| MGMT unmethylated Cohort A | Active comparator | Drug: Capecitabine plus temozolomide VS CapecitabineMGMT unmethylated A patients will be randomised into preoperative CRT with temozolomide plus capecitabine arms. (n=37) |
| MGMT unmethylated Cohort B | Active comparator | Drug: Capecitabine plus temozolomide VS CapecitabineMGMT unmethylated B patients will be randomised into preoperative CRT with capecitabine arms. (n=37) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- To be eligible for inclusion, each patient must fulfill each of the following criteria:
- Hematopoietic function: ANC 1,500/mm3, Platelet 100,000/mm3 Hepatic function: serum bilirubin 2.0 mg/dL, AST/ALT levels 2.5 x UNL Renal function: serum creatinine UNL or Cockroft creatinine clearance 50 ml/min
Key exclusion criteria (18 listed)
- Patients will be exluded from the study for any of the following reasons:
- Histology other than adenocarcinoma or tumor arising from inflammatory bowel disease
- Inadequate tumor sample for MGMT MSP
- Any evidence of systemic metastasis
- Unresected synchronous colon cancer; endoscopically resected synchronous colon cancer of pTis or pT1 is permitted
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 |
|---|---|---|
| Capecitabine plus temozolomide VS CapecitabineAlso: Temoram, XelodaFor each cohort of MGMT hypermethylated versus MGMT unmethylated, patients will be randomised (ratio 1:1 for each arm) into preoperative CRT with capecitabine or preoperative CRT with temozolomide plus capecitabine arms. Chemotherapy during preoperative chemoradiotherapy: Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break). dosage: Capecitabine 825 mg/m2 twice daily, Temozolomide 75 mg/m2/day | Drug | MGMT hypermethylated Cohort A, MGMT hypermethylated Cohort B, MGMT unmethylated Cohort A, MGMT unmethylated Cohort B |
Primary outcome
Pathologic complete response rate(Pathologic staging and tumor regression grade.)
Time frame: 6 weeks(maximum 7 weeks)
Surgery is after the completion of CRT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 36376167Oh CR, Kim JE, Lee JS, Kim SY, Kim TW, Choi J, Kim J, Park IJ, Lim SB, Park JH, Kim JH, Choi MK, Cha Y, Baek JY, Beom SH, Hong YS. Preoperative Chemoradiotherapy With Capecitabine With or Without Temozolomide in Patients With Locally Advanced Rectal Cancer: A Prospective, Randomised Phase II Study Stratified by O6-Methylguanine DNA Methyltransferase Status: KCSG-CO17-02. Clin Oncol (R Coll Radiol). 2023 Feb;35(2):e143-e152. doi: 10.1016/j.clon.2022.10.016. Epub 2022 Nov 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine plus temozolomide VS Capecitabine in people with Advanced Rectal Cancer, run by Asan Medical Center at 1 site 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 12 inclusion and 18 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: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response rate(Pathologic staging and tumor regression grade.) (time frame: 6 weeks(maximum 7 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03156036, which also lists 1 linked publication.
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 7 Sep 2023.