Locally Advanced Colorectal CancerPhase 3NCT02965248
Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)
A Phase 3 study testing Standard adjuvant systemic chemotherapy, Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed and Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin in people with Locally Advanced Colorectal Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Colorectal Cancer
- What is being tested?
- Standard adjuvant systemic chemotherapy, Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed and Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Nov 2023
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Joined the study voluntarily and signed informed consent form
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Life expectancy of more than 5 years
- Colorectal adenocarcinoma / mucinous adenocarcinoma / signet ring cell cancer confirmed by histopathology
- Stage T4NanyM0 cancer; or stage T3NanyM0 mucinous adenocarcinoma / signet ring cell cancer / adenocarcinoma with partly mucinous adenocarcinoma or signet ring cell cancer
- R0 resection of colorectal cancer
- Neutrophils (ANC) ≥ 1.5×10^9/L, Platelet count (Pt) ≥ 100× 10^9/L, Hemoglobin (Hb) ≥ 80 g/L, Hepatic function: ALT and AST ≤ 2.5 times upper limit of normal (ULN) and TBIL ≤ 1.5 times ULN, Renal function: creatinine ≤ 1.5 times ULN
- Use of an effective contraceptive for adults to prevent pregnancy
Who cannot join
- Rectal cancer below peritoneal reflection (≤ 8cm above the anal verge)
- Other malignant tumors within the past 5 years, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived from radical treatment
- Severe adhesion of peritoneal cavity impossible to separate
- Abdominal infection
- Allergic to raltitrexed, 5-FU, and oxaliplatin; Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
- Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
Show all 9Show fewer
- Drug addiction, Alcoholism or AIDS
- Impossible to tolerate the operation due to severe cardiac, lung, and vascular diseases
- Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Guoxiang Cai, M.D. Ph.D., +86 13611831623, gxcai@fudan.edu.cn
About this study
Official title: Multicenter, Randomized Controlled Trial Designed to Evaluate the Efficacy and Safety of Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Raltitrexed or Oxaliplatin Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)
This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer
Read the detailed description
Peritoneum is one of the common sites of metastasis in advanced stage colorectal cancer patients, resulting in a poor prognosis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is effective to colorectal peritoneal metastasis and may play a significant role in reducing the risk of metachronous peritoneal metastasis among patients with locally advanced colorectal cancer. Oxaliplatin is routinely used for HIPEC in the Europe and Raltitrexed may be another ideal drug for HIPEC. The present phase II multicenter, randomized controlled trial is designed to evaluate the efficacy and safety of adjuvant HIPEC with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer.
- Conditions
- Locally Advanced Colorectal Cancer
- Being tested
- Standard adjuvant systemic chemotherapy, Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed, Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin
- Keywords
- Locally advanced colorectal cancer, Hyperthermic intraperitoneal chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard adjuvant systemic chemotherapyDrug
Also called adjuvant oxaliplatin, 5-FU, and leucovorin calcium (mFOLFOX6), adjuvant oxaliplatin and capecitabine (CapeOx), adjuvant 5-FU and leucovorin calcium (sLV5FU2), adjuvant capecitabine (Cape)
Patients undergo radical surgery with standard adjuvant systemic chemotherapy (mFOLFOX6/CapeOx/sLV5FU2/Cape).
mFOLFOX6: oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.
CapeOx: oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.
sLV5FU2: leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.
Cape: capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.
Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexedProcedure or surgery
Also called Intraperitoneal raltitrexed 3 mg/m2
Raltitrexed (3 mg/m2) is added to the perfusate after attaining 42 degrees of inflow temperature and last for 60 minutes.
Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatinProcedure or surgery
Also called I.V. leucovorin calcium 20 mg/m2, I.V. 5-FU 400 mg/m2, Intraperitoneal oxaliplatin 130 mg/m2
Before the beginning of HIPEC, 5-FU 400 mg/m2 and leucovorin calcium 20 mg/m2 will be administered intravenously to potentiate oxaliplatin activity. Oxaliplatin (130 mg/m2) is added to the perfusate after attaining 42 degrees inflow temperature with a total of 30 minutes perfusion time.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Patients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months. Receives: Drug: Standard adjuvant systemic chemotherapy |
| Arm B | Experimental | Patients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months. Patients also undergo HIPEC with raltitrexed (3mg/m2) intraperitoneally for 60 minutes during surgery or within 10 days after the operation. Receives: Drug: Standard adjuvant systemic chemotherapy; Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed |
| Arm C | Experimental | Patients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months. Patients also undergo HIPEC comprising oxaliplatin (130mg/m2) intraperitoneally during surgery and hyperthermia for 30 minutes, following leucovorin calcium (20mg/m2 intravenously) and 5-FU (400 mg/m2 intravenously) Receives: Drug: Standard adjuvant systemic chemotherapy; Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
peritoneal metastasis rate
Measured: 3 years
Secondary outcomes (5)
liver metastasis rate
Measured: 3 years
disease free survival
Measured: 3 years
overall survival
Measured: 5 years
quality of life questionnaire
Measured: 6 months
Toxicity by NCI CTCAE v.4.0
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2021 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoxiang Cai, Fudan University
- Investigators
- Guoxiang Cai, M.D. Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965248
- Sponsor's protocol ID
- 1608163-15
- Status last verified
- Jun 2018
- First submitted
- 11 Nov 2016
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized Controlled Trial Designed to Evaluate the Efficacy and Safety of Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Raltitrexed or Oxaliplatin Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)
- ClinicalTrials.gov ID
- NCT02965248
- Acronym / sponsor ID
- 1608163-15
- Conditions
- Locally Advanced Colorectal Cancer
- Keywords
- Locally advanced colorectal cancer, Hyperthermic intraperitoneal chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 16 Nov 2016 (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.
This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer
Detailed description
Peritoneum is one of the common sites of metastasis in advanced stage colorectal cancer patients, resulting in a poor prognosis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is effective to colorectal peritoneal metastasis and may play a significant role in reducing the risk of metachronous peritoneal metastasis among patients with locally advanced colorectal cancer. Oxaliplatin is routinely used for HIPEC in the Europe and Raltitrexed may be another ideal drug for HIPEC. The present phase II multicenter, randomized controlled trial is designed to evaluate the efficacy and safety of adjuvant HIPEC with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Standard adjuvant systemic chemotherapyPatients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months. |
| Arm B | Experimental | Drug: Standard adjuvant systemic chemotherapy, Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexedPatients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months. Patients also undergo HIPEC with raltitrexed (3mg/m2) intraperitoneally for 60 minutes during surgery or within 10 days after the operation. |
| Arm C | Experimental | Drug: Standard adjuvant systemic chemotherapy, Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatinPatients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months. Patients also undergo HIPEC comprising oxaliplatin (130mg/m2) intraperitoneally during surgery and hyperthermia for 30 minutes, following leucovorin calcium (20mg/m2 intravenously) and 5-FU (400 mg/m2 intravenously) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Joined the study voluntarily and signed informed consent form
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Life expectancy of more than 5 years
- Colorectal adenocarcinoma / mucinous adenocarcinoma / signet ring cell cancer confirmed by histopathology
- Stage T4NanyM0 cancer; or stage T3NanyM0 mucinous adenocarcinoma / signet ring cell cancer / adenocarcinoma with partly mucinous adenocarcinoma or signet ring cell cancer
Key exclusion criteria (9 listed)
- Rectal cancer below peritoneal reflection (≤ 8cm above the anal verge)
- Other malignant tumors within the past 5 years, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived from radical treatment
- Severe adhesion of peritoneal cavity impossible to separate
- Abdominal infection
- Allergic to raltitrexed, 5-FU, and oxaliplatin; Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
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 |
|---|---|---|
| Standard adjuvant systemic chemotherapyAlso: adjuvant oxaliplatin, 5-FU, and leucovorin calcium (mFOLFOX6), adjuvant oxaliplatin and capecitabine (CapeOx), adjuvant 5-FU and leucovorin calcium (sLV5FU2), adjuvant capecitabine (Cape)Patients undergo radical surgery with standard adjuvant systemic chemotherapy (mFOLFOX6/CapeOx/sLV5FU2/Cape). mFOLFOX6: oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles. CapeOx: oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles. sLV5FU2: leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles. Cape: capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles. | Drug | Arm A, Arm B, Arm C |
| Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexedAlso: Intraperitoneal raltitrexed 3 mg/m2Raltitrexed (3 mg/m2) is added to the perfusate after attaining 42 degrees of inflow temperature and last for 60 minutes. | Procedure or surgery | Arm B |
| Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatinAlso: I.V. leucovorin calcium 20 mg/m2, I.V. 5-FU 400 mg/m2, Intraperitoneal oxaliplatin 130 mg/m2Before the beginning of HIPEC, 5-FU 400 mg/m2 and leucovorin calcium 20 mg/m2 will be administered intravenously to potentiate oxaliplatin activity. Oxaliplatin (130 mg/m2) is added to the perfusate after attaining 42 degrees inflow temperature with a total of 30 minutes perfusion time. | Procedure or surgery | Arm C |
Primary outcome
peritoneal metastasis rate
Time frame: 3 years
5 secondary outcomes
liver metastasis rate
Time frame: 3 years
disease free survival
Time frame: 3 years
overall survival
Time frame: 5 years
quality of life questionnaire
Time frame: 6 months
Toxicity by NCI CTCAE v.4.0
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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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.
Guoxiang Cai, M.D. Ph.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard adjuvant systemic chemotherapy, Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed and Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin in people with Locally Advanced Colorectal Cancer, run by Fudan University at 1 site in China.
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 9 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 19 Jun 2018. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peritoneal metastasis rate (time frame: 3 years). 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 19 Jun 2018.