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Rectal Cancer RecurrentPhase 3JCOG1801NCT04288999

Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer

A Phase 3 study testing Chemotherapy, Preoperative radiotherapy and Procedure in people with Rectal Cancer Recurrent, run by National Cancer Center Hospital East at 45 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Rectal Cancer Recurrent
What is being tested?
Chemotherapy, Preoperative radiotherapy and Procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
45 sitesJapan
Study dates
1 Oct 2019to Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Surgical resection (including local resection, with or without lymph node dissection).
  • Endoscopic resection.
  • 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.
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  • Recurrent rectal cancer diagnosed by any of the following modalities after treatment for the initial rectal cancer.
  • The recurrent lesion is pathologically diagnosed. ii) Diagnosed as local recurrence by more than two modalities among contrast-enhanced CT, contrast-enhanced MRI, or positron emission computed tomography (PET).
  • Chronological progression of the lesion seen on more than one modality among contrast-enhanced CT, MRI, or PET.
  • 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 intestine iii) Solitary ovarian metastasis. iv) Recurrence of the common iliac lymph node alone.
  • LRRC is diagnosed as resectable, and all the following conditions must be fulfilled:
  • No distant metastasis on contrast-enhanced CT (cM0). ii) Estimated circumferential resection margin >0 mm. iii) Leg amputation not required. iv) Preservation of the first sacral nerve possible.
  • 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 Aminotransferase (ALT) =< 100 U/L vii) Cr =< 1.5 mg/dL
  • Open surgery or laparoscopic surgery is planned.
  • Written informed consent is obtained.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

45 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yuichiro Tsukada, MD,PhD contact

+80-4-7133-1111

yutsukad@east.ncc.go.jp

Masaaki Ito, MD, PhD contact

+80-4-7133-1111

maito@east.ncc.go.jp

45 sites in 1 country

Japan45 sites, 45 recruiting

  • Chiba Cancer Center

    Chiba

    Nobuhiro Takiguchi

    Recruiting

  • Gifu University School of Medicine

    Gifu

    Kazuhiro Yoshida

    Recruiting

  • Saitama Medical University International Medical Center

    Hidaka

    Shigeki Yamaguchi

    Not yet recruiting

  • Kansai Medical University Hospital

    Hirakata

    Mitsugu Sekimoto

    Not yet recruiting

  • Hiroshima City Asa Citizens Hospital

    Hiroshima

    Mamoru Shimomura

    Recruiting

  • Hiroshima City Hospital

    Hiroshima

    Masazumi Okajima

    Recruiting

  • Shimane University Faculty of Medicine

    Izumo

    Yoshitsugu Tajima

    Recruiting

  • Ishikawa Prefectural Central Hospital

    Kanazawa

    Hiroyuki Bando

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa

    Masaaki Ito

    Recruiting

  • Saitama Medical Center, Saitama Medical University

    Kawagoe

    Hideyuki Ishida

    Recruiting

  • Kochi Health Sciences Center

    Kochi

    Ryo Inada

    Recruiting

  • Kumamoto University Hospital

    Kumamoto

    Hideo Baba

    Recruiting

  • Kurashiki Central Hospital

    Kurashiki

    Kazuyuki Kawamoto

    Recruiting

  • Kurume University School of Medicine

    Kurume

    Yoshito Akagi

    Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama

    Takaya Kobatake

    Recruiting

  • Kyorin University Faculty of Medicine

    Mitaka

    Tadahiko Masaki

    Recruiting

  • Iwate Medical University

    Morioka

    Koki Otsuka

    Not yet recruiting

  • Nagoya University Graduate School of Medicine

    Nagoya

    Keisuke Uehara

    Not yet recruiting

  • Niigata Cancer Center Hospital

    Niigata

    Yasumasa Takii

    Recruiting

  • Hyogo College of Medicine

    Nishinomiya

    Naohiro Tomita

    Recruiting

  • Ogaki Municipal Hospital

    Ōgaki

    Yuichi Takayama

    Recruiting

  • Okayama Saiseikai General Hospital

    Okayama

    Yoshihiro Akazai

    Recruiting

  • National Hospital Organization Osaka National Hospital

    Osaka

    Takeshi Kato

    Recruiting

  • Osaka City General Hospital

    Osaka

    Kiyoshi Maeda

    Recruiting

  • Gunma Prefectural Cancer Center

    Ōta-ku

    Hitoshi Ojima

    Recruiting

  • Saitama Cancer Center

    Saitama

    Yusuke Nishizawa

    Recruiting

  • Sapporo-Kosei General Hospital

    Sapporo

    Hideki Yamagami

    Recruiting

  • Miyagi Cancer Center

    Sendai

    Kou Miura

    Recruiting

  • Shizuoka Cancer Center

    Shizuoka

    Akio Shiomi

    Recruiting

  • Osaka University Graduate School of Medicine

    Suita

    Tsunekazu Mizushima

    Recruiting

  • Suita Municipal Hospital

    Suita

    Shu Okamura

    Recruiting

  • Osaka Medical College

    Takatsuki

    Junji Okuda

    Recruiting

  • National Defense Medical College

    Tokorozawa

    Hideki Ueno

    Recruiting

  • National Cancer Center Hospital

    Tokyo

    Yukihide Kanemitsu

    Recruiting

  • Toho University Ohashi Medical Center

    Tokyo

    Yoshihisa Saida

    Recruiting

  • Toho University Omori Medical Center

    Tokyo

    Kimihiko Funahashi

    Not yet recruiting

  • Tokyo Medical and Dental University Hospital

    Tokyo

    Yusuke Kinugasa

    Recruiting

  • Tokyo Medical University Hospital

    Tokyo

    Akihiko Tsuchida

    Recruiting

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Tokyo

    Keiichi Takahashi

    Recruiting

  • Tochigi Cancer Center

    Utsunomiya

    Shin Fujita

    Recruiting

  • Yamagata Prefectural Central Hospital

    Yamagata

    Toshihiko Sato

    Recruiting

  • Kanagawa Cancer Center

    Yokohama

    Manabu Shiozawa

    Recruiting

  • Saiseikai Yokohama-shi Nanbu Hospital

    Yokohama

    Tadao Fukushima

    Recruiting

  • Yokohama City University Medical Center

    Yokohama

    Jun Watanabe

    Recruiting

  • Oita University Faculty of Medicine

    Yufu

    Masafumi Inomata

    Recruiting

Other trials in Japan

About this study

Official title: JCOG1801: A Phase III Randomized Controlled Trial Comparing Surgery Plus Adjuvant Chemotherapy With Preoperative Chemoradiotherapy Followed by Surgery Plus Adjuvant Chemotherapy for Locally Recurrent Rectal Cancer (RC-SURVIVE Study)

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.

Read the detailed description

In all, 110 patients from 43 Japanese institutions will be recruited over a period of 6 years. Eligible patients would be registered and randomly assigned to each group with an allocation ratio of 1:1. The primary endpoint is local relapse-free survival. The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions), and quality of life after surgery.

Being tested
Chemotherapy, Preoperative radiotherapy, Procedure
Keywords
Rectal cancer, Locally recurrent rectal cancer, Chemoradiotherapy, Surgery, Chemotherapy
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemotherapyDrug

    Also called CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV

    Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV

    CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14)

    mFOLOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours.

    Capecitabine: 2000 mg/m2/day, twice daily, days 1-14

    5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours

  • Preoperative radiotherapyRadiation

    Also called Capecitabine plus radiotherapy

    Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy

    Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)

  • ProcedureOther

    Also called Surgery

    Surgery for Locally Recurrent Rectal Cancer (LRRC) will be performed within 42 days from registration for the patients in arm A, and between days 56 and 98 from the completion of the preCRT for the patients in arm B.

    Appropriate surgical procedure will be performed to achieve R0 resection, such as low anterior resection, super low anterior resection, intersphincteric resection, Hartmann procedure, rectal amputation, pelvic exenteration, tumor resection, or lateral lymph node dissection

Study groups in NCT04288999
Study groupRoleWhat they receive
Arm AExperimentalPreoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr) Adjuvant chemotherapy: CAPOX (capecitabine+oxaliplatin) or mFOLFOX6 (5-fluorouracil+l-leucovorin+oxaliplatin) or capecitabine or 5-fluorouracil (FU) +l-leucovorin (LV) CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14) mFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours. Capecitabine: 2000 mg/m2/day, twice daily, days 1-14 5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours
Receives: Drug: Chemotherapy; Radiation: Preoperative radiotherapy; Other: Procedure
Arm BActive comparatorSurgery plus Adjuvant chemotherapy Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14) mFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours. Capecitabine: 2000 mg/m2/day, twice daily, days 1-14 5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours
Receives: Drug: Chemotherapy; Other: Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Locally recurrent free survival

    the period from registration in the trial to either the first event of local relapse or death from any cause and censored at the last date of contact for a living patient

    Measured: 3-years after registration

Secondary outcomes (10)

  1. Overall survival (OS)

    s the time from registration to death from any cause and censored at the last date of contact for a living patient

    Measured: 3-years after registration

  2. Recurrence free survival (RFS)

    the time from registration to either the first incidence of relapse or death from any cause and censored at the last date of contact for a living patient

    Measured: 3-years after registration

  3. Local relapse rate

    Proportion of local relapse

    Measured: 3-years after registration

  4. Distant relapse rate

    Proportion of distant relapse

    Measured: 3-years after registration

  5. R0 resection rate

    Proportion of patients with pathological R0 resection

    Measured: 1 month after surgery

  6. Response rate of preoperative chemoradiotherapy (preCRT)

    Response rate of preCRT (arm B)

    Measured: before surgery

  7. Pathological complete response rate

    Pathological complete response rate (arm B)

    Measured: 1 month after surgery

  8. Completeness of the protocol treatment

    Proportion of patients who completed the protocol treatment

    Measured: 8 months after surgery

  9. Adverse event rate

    Incidence of adverse events (adverse reactions)

    Measured: 3-years after surgery registration

  10. QOL

    QOL after surgery based on the Trial Outcome Index-Physical/Functional/Colorectal (TOI-PFC) [0(better)-84(worse)]

    Measured: 3-years after registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2020
  2. Study start1 Oct 2019
  3. Primary completionAug 2025 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

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
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04288999
Sponsor's protocol ID
JCOG1801
Acronym
JCOG1801
Status last verified
Jun 2020
First submitted
26 Feb 2020
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hashimoto T, Tsukada Y, Ito M, Kanato K, Mizusawa J, Fukuda H, Tsukamoto S, Takashima A, Kanemitsu Y. Utility of circulating tumour DNA for prognosis and prediction of therapeutic effect in locally recurrent rectal cancer: study protocol for a multi-institutional, prospective observational study (JCOG1801A1, CAP-LR study). BMJ Open. 2023 Aug 16;13(8):e073217. doi: 10.1136/bmjopen-2023-073217.

    PubMed 37586869

  • Kadota T, Tsukada Y, Ito M, Katayama H, Mizusawa J, Nakamura N, Ito Y, Bando H, Ando M, Onaya H, Fukuda H, Kanemitsu Y. A phase III randomized controlled trial comparing surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for locally recurrent rectal cancer: Japan Clinical Oncology Group study JCOG1801 (RC-SURVIVE study). Jpn J Clin Oncol. 2020 Aug 4;50(8):953-957. doi: 10.1093/jjco/hyaa058.

    PubMed 32409830

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chemotherapy, Preoperative radiotherapy and Procedure in people with Rectal Cancer Recurrent, run by National Cancer Center Hospital East at 45 sites in Japan.

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 23 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Japan. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuichiro Tsukada, MD,PhD (+80-4-7133-1111, yutsukad@east.ncc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Locally recurrent free survival (time frame: 3-years after registration). 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 NCT04288999, which also lists 2 linked publications.

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 4 Jun 2020.

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