UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016785 |
|---|---|
| Receipt number | R000019479 |
| Scientific Title | Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer after the local resection |
| Date of disclosure of the study information | 2015/03/12 |
| Last modified on | 2022/03/16 11:47:46 |
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Basic information
Public title
Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer after the local resection
Acronym
Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer
Scientific Title
Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer after the local resection
Scientific Title:Acronym
Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer
Region
| Japan |
Condition
Condition
rectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility of adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer after the local resection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of treatment completion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
adjuvant chemoradiotherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Rectal cancer
2) Local resection is performed within 12 weeks before registration day.
3) En bloc resection and margins negative
4) Histopathologically, the lesion is pSM cancer and it satisfies any one or more of the following conditions.
1. poorly differentiated adenocarcinoma
2. depth of submucosal invasion more than 1mm
3. lymphovascular invasion positive
4. budding Grade 2,3
5) No lymph node metastases and distant metastasis in diagnostic imaging within 16 weeks before registration
6) Rejection of the surgery
7) ECOG Performance Status PS:0,1
8) No history of the chemotherapy and radiotherapy
10) Blood data
1. WBC>3000/mm3
2. Hb>9.0g/dL
3. Plt>100,000/mm3
4. AST,ALT<100 IU/L
5. t-bil<2.0mg/dL
6. Cr<1.5mg/dL
11) Agreement from the patients
Key exclusion criteria
1)Presence of synchronous or metachronous advanced colorectal cancer and malignant diseases in any other
organs
2)Pregnant woman
3)Patients with psychosis
4)Use of the phenytoin and warfarin potassium
5)Use of steroids
6)Activity of hepatitis B or hepatitis C
7)Systemic infection
8)Others
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ikematsu |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology & Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
hikemats@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Noguchi |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology & Gastrointestinal Oncology
Zip code
277-0871
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
manoguch@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
愛知県がんセンター中央病院（愛知県）、石川県立中央病院（石川県）、京都大学病院（京都府）、国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉県）、新潟県立がんセンター新潟病院（新潟県）、山形県立中央病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
No URL for protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33558891/
Number of participants that the trial has enrolled
29
Results
One patient was ineligible. Twenty-three patients completed treatment, with a completion rate of 82% (80% confidence interval, 69-91%); the remaining five patients completed treatment with protocol deviation. The median relative dose intensity of capecitabine was 100% (range, 58-100%). Common adverse events included radiation dermatitis (54%), anal pain (39%) and anal mucositis (29%). No grade-3 or higher adverse events were reported.
Results date posted
| 2022 | Year | 03 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 02 | Month | 09 | Day |
Baseline Characteristics
A total of 29 patients from the six participating institutions were enrolled between May 2015 and February 2018. The median age was 67 (range, 33-77) years, and 64% of the patients were males. All patients had an Eastern Cooperative Oncology Group PS score of 0. The majority of the patients (75%) had rectal cancer below the peritoneal reflection. Seven (25%) patients underwent transanal resection. Regarding histological factors associated with high risk, 26 (95%) patients had a submucosal invasion depth of >1 mm, 10 (36%) patients had lymphovascular invasion, 7 (25%) patients had a tumor budding grade of 2 or 3, and none of the patients had poorly differentiated/mucinous adenocarcinoma or signet ring-cell carcinoma. Overall, 16 (57%), 9 (32%) and 3 (11%) patients had one, two and three histological high-risk factors, respectively. The median interval from resection to CRT was 58 (29-99) days.
Participant flow
Protocol treatment comprised 45.0 Gy radiotherapy with conventional fractionation and 1650 mg/m2 capecitabine given twice daily until radiotherapy completion.
Adverse events
All 28 patients completed RT without any interruption due to adverse events. One patient (4%) discontinued capecitabine due to drug-related toxicity (grade-2 hand-foot syndrome), although this patient met the criteria for treatment completion (>75% of the planned dose received). The remaining 27 (96%) patients were administered capecitabine treatment until the end of RT. No one reduced the dosage of capecitabine and delayed the protocol treatment due to adverse events. No adverse events of grade 3 or higher were observed.
Outcome measures
One patient was ineligible. Twenty-three patients completed treatment, with a completion rate of 82% (80% confidence interval, 69-91%); the remaining five patients completed treatment with protocol deviation. The median relative dose intensity of capecitabine was 100% (range, 58-100%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 02 | Month | 26 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019479
