BridgeMD
Compares treatment options for Rectal Cancer Recurrent
Official title Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer
ClinicalTrials.gov ID: NCT04288999
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for rectal cancer recurrent.
Also referred to as CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- JCOG1801 is a randomized phase III trial which was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for local relapse-free survival over standard treatment, i.e. surgery plus adjuvant chemotherapy, for previously non-irradiated locally recurrent rectal cancer.
- Phase 3: a large, late-stage study
- Time commitment: about 6 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80
You may be able to join if
- Histopathologically proven adenocarcinoma or adenosquamous carcinoma on the resected specimen of the initial rectal cancer or endoscopic biopsy from...
- The main tumor location of the initial rectal cancer is upper, middle or lower rectum, or anal canal.
- Either of the following treatments was performed for the initial rectal cancer, and classified as R0/1 or ER (Endoscopical R)0/1 on pathological...
- Patients with distant metastasis during or after treatment for the initial rectal cancer, and radical surgical resection or radical radiotherapy...
- Recurrent rectal cancer diagnosed by any of the following modalities after treatment for the initial rectal cancer. i) The recurrent lesion is...
You likely can't join if
- Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ...
- Infections requiring systemic treatment.
- Body temperature higher than 38 degrees Celsius at registration.
- Pregnant female, female within 28 days post-parturition, or lactating mother. Men with partners planning conception in the near future.
- Severe psychological disease.
- Continuous systemic corticosteroid or immunosuppressant treatment.
See the full eligibility criteria
- Histopathologically proven adenocarcinoma or adenosquamous carcinoma on the resected specimen of the initial rectal cancer or endoscopic biopsy from the initial rectal cancer.
- The main tumor location of the initial rectal cancer is upper, middle or lower rectum, or anal canal.
- Either of the following treatments was performed for the initial rectal cancer, and classified as R0/1 or ER (Endoscopical R)0/1 on pathological diagnosis. i) Surgical resection (including local resection, with or...
- Patients with distant metastasis during or after treatment for the initial rectal cancer, and radical surgical resection or radical radiotherapy performed more than 168 days before registration is eligible.
- Recurrent rectal cancer diagnosed by any of the following modalities after treatment for the initial rectal cancer. i) The recurrent lesion is pathologically diagnosed. ii) Diagnosed as local recurrence by more than two...
- The main tumor location is within pelvis as seen on contrast-enhanced CT and MRI if recurrent lesion is multiple, or recurrent lesions spread outside of pelvis continuously.
- LRRC is diagnosed with no following condition. i) Judged as resectable endoscopically. ii) Depth of invasion within the muscularis propria as seen on contrast-enhanced CT, MRI, or PET in case of recurrence inside the...
- LRRC is diagnosed as resectable, and all the following conditions must be fulfilled: i) No distant metastasis on contrast-enhanced CT (cM0). ii) Estimated circumferential resection margin \>0 mm. iii) Leg amputation not...
- No prior surgery for recurrent rectal cancer.
- No prior pelvic irradiation for any malignancies.
- A patient who has received systemic chemotherapy for any malignancies and the final dose was administered more than 14 days ago.
- Age at registration is 20 to 80 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1.
- Measurable lesion is not mandatory.
- Adequate oral intake.
- Sufficient organ function. i) Neutrophil count \>= 1,500/mm3 ii) Hemoglobin \>= 9.0 g/dL iii) Platelet count \>= 100,000/mm3 iv) Total Bilirubin =\< 2.0 mg/dL v) Aspartate aminotransferase (AST) =\< 100 U/L vi) Alanine...
- Open surgery or laparoscopic surgery is planned.
- Written informed consent is obtained.
- Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
- Infections requiring systemic treatment.
- Body temperature higher than 38 degrees Celsius at registration.
- Pregnant female, female within 28 days post-parturition, or lactating mother. Men with partners planning conception in the near future.
- Severe psychological disease.
- Continuous systemic corticosteroid or immunosuppressant treatment.
- Uncontrollable diabetes mellitus.
- Uncontrollable hypertension.
- Unstable angina pectoris, or history of myocardial infarction within 6 months.
- Uncontrollable valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
- Positive serum Hepatitis B (HB)s antigen or serum Hepatitis C Virus (HCV) antibody.
- Positive serum HIV antibody.
- Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT.
The study team makes the final eligibility decision.
Where it's taking place
- Chiba, Japan
- Gifu, Japan
- Hidaka, Japan
- Hirakata, Japan
- Hiroshima, Japan
- Izumo, Japan
- Kanazawa, Japan
- Kashiwa, Japan
- Kawagoe, Japan
- Kochi, Japan
- Kumamoto, Japan
- Kurashiki, Japan
- Kurume, Japan
- Matsuyama, Japan
- Mitaka, Japan
- Morioka, Japan
- Nagoya, Japan
- Niigata, Japan
- Nishinomiya, Japan
- Okayama, Japan
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chiba, Japan; Gifu, Japan; Hidaka, Japan; Hirakata, Japan; Hiroshima, Japan; Izumo, Japan and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.