Rectal CancerPhase 2Lap RCNCT00635466
Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
A Phase 2 study testing laparoscopic surgery for rectal carcinoma in people with Rectal Cancer, run by Japan Society of Laparoscopic Colorectal Surgery at 1 site in Japan.
Trial summary
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- laparoscopic surgery for rectal carcinoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2008to Sep 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven rectal carcinoma.
- Tumor located in the rectum.
- Clinical Tis, T1, T2 N0 M0
- Without multiple lesions other than carcinoma in situ
- Tumor size <8 cm.
- Sufficient organ function.
Show all 10Show fewer
- No bowel obstruction.
- No history of major colorectal surgery.
- No history of chemotherapy or radiotherapy.
- Provide written informed consent.
Who cannot join
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
- Pregnant or lactating women.
- Severe mental disease.
- Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease.
- Continuous systemic steroid therapy.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma
Read the detailed description
Recently reported randomized controlled trials demonstrated that laparoscopic surgery was comparable or superior to open surgery regarding the long-term outcome for colon and rectosigmoidal carcinoma; however, controversy persists regarding the appropriateness of laparoscopic surgery for patients with rectal carcinoma because of the uncertainty of the long-term outcome, and of concerns over the safety of the procedure. In Japan, lateral lymph node dissection combined with total mesorectal excision remains the standard surgical procedure for patients with advanced lower rectal carcinoma, and lateral lymph node dissection by laparoscopy is still an unexplored frontier. To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, a phase II trial will be conducted in patients with a preoperative diagnosis of stage 0/I rectal carcinoma, under the direction of the Japan Society of Laparoscopic Colorectal Surgery, to which leading hospitals in laparoscopic surgery for colorectal carcinoma in Japan are members.
- Conditions
- Rectal Cancer
- Being tested
- laparoscopic surgery for rectal carcinoma
- Keywords
- laparoscopic surgery, rectal carcinoma, phase II trial
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgery for rectal carcinomaProcedure or surgery
Also called laparoscopic rectal resection
Laparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum. The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge. Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle. Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (<8 cm).
| Study group | Role | What they receive |
|---|---|---|
| Lap, 1 | Experimental | Patients undergoing laparoscopic surgery for rectal carcinoma Receives: Procedure: laparoscopic surgery for rectal carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5 year
Secondary outcomes (1)
anastomotic leakage rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Society of Laparoscopic Colorectal Surgery
- Sponsor type
- Research network
- Investigators
- Masahiko Watanabe, PhD, Study chair, Kitasato University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635466
- Sponsor's protocol ID
- Lap RC
- Other IDs
- NCCHCT19-49
- Acronym
- Lap RC
- Status last verified
- Jun 2011
- First submitted
- 6 Mar 2008
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yamamoto S, Yoshimura K, Konishi F, Watanabe M. Phase II trial to evaluate laparoscopic surgery for Stage 0/I rectal carcinoma. Jpn J Clin Oncol. 2008 Jul;38(7):497-500. doi: 10.1093/jjco/hyn054. Epub 2008 Jun 26.
PubMed 18586667Ito M, Yamamoto S, Okuda J, Fujii S, Yamaguchi S, Otsuka K, Yoshimura K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Long-term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma. Ann Gastroenterol Surg. 2020 May 20;4(3):294-300. doi: 10.1002/ags3.12333. eCollection 2020 May.
PubMed 32490343Yamamoto S, Ito M, Okuda J, Fujii S, Yamaguchi S, Yoshimura K, Sugihara K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Laparoscopic surgery for stage 0/I rectal carcinoma: short-term outcomes of a single-arm phase II trial. Ann Surg. 2013 Aug;258(2):283-8. doi: 10.1097/SLA.0b013e318283669c.
PubMed 23426337
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
- ClinicalTrials.gov ID
- NCT00635466
- Acronym / sponsor ID
- Lap RC / Lap RC
- Conditions
- Rectal Cancer
- Keywords
- laparoscopic surgery, rectal carcinoma, phase II trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Japan Society of Laparoscopic Colorectal SurgeryResearch network
- Study start
- Feb 2008
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 13 Mar 2008 (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.
The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma
Detailed description
Recently reported randomized controlled trials demonstrated that laparoscopic surgery was comparable or superior to open surgery regarding the long-term outcome for colon and rectosigmoidal carcinoma; however, controversy persists regarding the appropriateness of laparoscopic surgery for patients with rectal carcinoma because of the uncertainty of the long-term outcome, and of concerns over the safety of the procedure. In Japan, lateral lymph node dissection combined with total mesorectal excision remains the standard surgical procedure for patients with advanced lower rectal carcinoma, and lateral lymph node dissection by laparoscopy is still an unexplored frontier. To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, a phase II trial will be conducted in patients with a preoperative diagnosis of stage 0/I rectal carcinoma, under the direction of the Japan Society of Laparoscopic Colorectal Surgery, to which leading hospitals in laparoscopic surgery for colorectal carcinoma in Japan are members.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lap, 1 | Experimental | Procedure: laparoscopic surgery for rectal carcinomaPatients undergoing laparoscopic surgery for rectal carcinoma |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven rectal carcinoma.
- Tumor located in the rectum.
- Clinical Tis, T1, T2 N0 M0
- Without multiple lesions other than carcinoma in situ
- Tumor size <8 cm.
Key exclusion criteria (5 listed)
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
- Pregnant or lactating women.
- Severe mental disease.
- Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease.
- Continuous systemic steroid therapy.
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 |
|---|---|---|
| laparoscopic surgery for rectal carcinomaAlso: laparoscopic rectal resectionLaparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum. The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge. Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle. Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (<8 cm). | Procedure or surgery | Lap, 1 |
Primary outcome
overall survival
Time frame: 5 year
1 secondary outcome
anastomotic leakage rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
- Background: PubMed 18586667Yamamoto S, Yoshimura K, Konishi F, Watanabe M. Phase II trial to evaluate laparoscopic surgery for Stage 0/I rectal carcinoma. Jpn J Clin Oncol. 2008 Jul;38(7):497-500. doi: 10.1093/jjco/hyn054. Epub 2008 Jun 26.
- Derived from this study: PubMed 32490343Ito M, Yamamoto S, Okuda J, Fujii S, Yamaguchi S, Otsuka K, Yoshimura K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Long-term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma. Ann Gastroenterol Surg. 2020 May 20;4(3):294-300. doi: 10.1002/ags3.12333. eCollection 2020 May.
- Derived from this study: PubMed 23426337Yamamoto S, Ito M, Okuda J, Fujii S, Yamaguchi S, Yoshimura K, Sugihara K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Laparoscopic surgery for stage 0/I rectal carcinoma: short-term outcomes of a single-arm phase II trial. Ann Surg. 2013 Aug;258(2):283-8. doi: 10.1097/SLA.0b013e318283669c.
- Click here for the information regarding the Japanese Society for Cancer of the Colon and Rectum (JSCCR).Link provided by the sponsor.
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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.
Masahiko Watanabe, PhD study chair
Kitasato University Hospital
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 laparoscopic surgery for rectal carcinoma in people with Rectal Cancer, run by Japan Society of Laparoscopic Colorectal Surgery at 1 site 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 10 inclusion and 5 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 16 Jun 2011. 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 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 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?
Results are not available in the source record.
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?
overall survival (time frame: 5 year). 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 NCT00635466, which also lists 3 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 16 Jun 2011.