Rectal Cancer, AdenocarcinomaNCT03042000
Multicenter, Prospective, RCT：Investigation of Combined Modality Therapy for Locally Advanced Mid/Low Rectal Cancer.
A study testing non-NCRT, NCRT and capecitabine with oxaliplatin in people with Rectal Cancer, Adenocarcinoma and Neoadjuvant Chemoradiation, run by Peking Union Medical College Hospital.
Trial summary
At present, the combined modality treatment of preoperative neoadjuvant chemoradiotherapy (NCRT) followed by radical surgery has become the standard of care for the locally advanced mid/low rectal cancer, having been proved to substantially improve the local control of the disease, whereas not being able to improve… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Adenocarcinoma, Neoadjuvant Chemoradiation
- What is being tested?
- non-NCRT, NCRT and capecitabine with oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Dec 2021
- Phase
- Interventional
- 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
- Patients aged 18 to 75 years old. Patients with cT3-4N0M0 or cTanyN+M0 mid/low rectal cancer. Patients with ASA physical status scroe of I to III. Patients who can fully understand the content of the informed consent form and sign it upon their own opinions.
- Patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-ups.
Who cannot join
- Patient has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosis etc.).
- Patient is pregnant or lactating. Patient has a history of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma in a non-mucosal, ultraviolet exposed area, or cervical carcinoma.
- Patient is participating in any other clinical trials within 30 days prior to screening.
- Patient has severe mental illness. Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Prospective, Randomized Clinical Trial to Investigate the Combined Modality Therapy for Locally Advanced Mid/Low Rectal Cancer.
At present, the combined modality treatment of preoperative neoadjuvant chemoradiotherapy (NCRT) followed by radical surgery has become the standard of care for the locally advanced mid/low rectal cancer, having been proved to substantially improve the local control of the disease, whereas not being able to improve the long-term survival. According to present clinical practice guidelines, all patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer are recommended to undergo the preoperative long-term radiotherapy with concurrent 5FU based chemotherapy, followed by the radical resection of the tumor. After surgery, adjuvant chemotherapy (ACT) is recommended for all these patients without considering the postoperative pathological results. Recently, however, some authors proposed that different strategy of combined modality therapy should be applied in different patients according to their risk of relapse, instead of using the uniform NCRT strategy. In this research, on the basis of investigator's previous clinical practice and researches, investigators plan to stratify the patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer into several subgroups according to tumor stages and the risk of relapse. Different therapeutic strategy will be applied in different groups, at the aim of improving the overall therapeutic effects, as well as reducing the treatment adverse effects.
This research consists of four trials.
Read the detailed description
Trial A: A multicenter, prospective, randomized trial to compare neoadjuvant chemoradiotherapy (NCRT) followed by radical surgery with surgery alone for cT3a-bN0-1aM0 mid rectal cancer.
Research objects: Patients with locally advanced rectal cancer, being clinically staged T3a-bN0-1aM0 by rectal MRI and/or endorectal ultrasonography (ERUS), the tumor being located 6-12 cm above the anal verge.
After giving fully informed consent, the prospective participants will be randomly divided into two groups, receiving the following two treatment modalities.
Group A1: radical surgery + adjuvant chemotherapy (ACT) Group A2: NCRT + radical surgery + ACT
Trial B: A multicenter, prospective, randomized trial to compare combined versus single-agent chemotherapy with concurrent radiotherapy for cT4NanyM0 or cTanyN2M0 rectal cancer.
Research objects: Patients with locally advanced rectal cancer, being clinically staged cT4NanyM0 or cTanyN2M0 by rectal MRI and/or ERUS, or patients with any other risk factors for tumor relapse.
After giving fully informed consent, the prospective participants will be randomly divided into two groups, receiving the following two treatment modalities.
Group A1: NCRT with combined chemotherapy (Capox regimen) + radical surgery + ACT Group A2: NCRT with single-agent chemotherapy (Capecitabine) + radical surgery + ACT
Trial C: A multicenter, prospective, randomized trial to compare transanal ndoscopic microsurgery (TEM) excision versus radical resection of rectal cancer being staged clinical complete response (cCR) after NCRT.
Research objects: Patients with locally advanced rectal cancer, being clinically staged cCR after NCRT.
After giving fully informed consent, the prospective participants will be randomly divided into two groups, receiving the following two treatment modalities.
Group A1: TEM excision + ACT Group A2: radical surgery + ACT
Trial D: A prospective, observational study to determine the value of circulating tumor DNA (ctDNA) for predicting the therapeutic effects of NCRT for locally advanced rectal cancer and the patients' long-term prognosis.
Research objects: Patients with locally advanced mid/low rectal cancer (cT3-4N0M0 or cTanyN+M0) who undergo NCRT.
After giving fully informed consent, the prospective participants will undergo the classical 'NCRT + radical surgery + ACT' comprehensive treatment. Serial analysis of ctDNA will be performed at specific time points including pre-NCRT, post-NCRT, postoperative week 1, post-ACT, postoperative year 1, 2, and 3. The next-generation sequencing of surgical specimens will be performed as well. Participants will be observed and examined during the entire course of treatment and the follow-up period. The pathological results of the surgical specimen and the 3 year disease free survival (3y-DFS) will be the main end-points.
- Being tested
- non-NCRT, NCRT, capecitabine with oxaliplatin, capecitabine, TEM
- Keywords
- rectal cancer, neoadjuvant chemoradiation, circulating tumor DNA, local recurrence, long-term survival
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-NCRTOther
without the preoperative concurrent chemoradiothearpy (no neoadjuvant chemoradiation)
NCRTOther
the preoperative concurrent chemoradiothearpy (neoadjuvant chemoradiation)
capecitabine with oxaliplatinDrug
combined chemotherapy with capecitabine with oxaliplatin
capecitabineDrug
single-agent chemotherapy with capecitabine
TEMProcedure or surgery
transanal endoscopic microsurgery (TEM) excision of the lesion
radical resectionProcedure or surgery
radical resection of rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Group A1 | Experimental | Patients with cT3a-bN0-1aM0 mid rectal cancer who undergo the treatment modality of 'radical surgery + adjuvant chemotherapy (ACT)' Receives: Other: non-NCRT |
| Group A2 | Active comparator | Patients with cT3a-bN0-1aM0 mid rectal cancer who undergo the treatment modality of 'NCRT + radical surgery + ACT' Receives: Other: NCRT |
| Group B1 | Experimental | Patients with cT4NanyM0 or cTanyN2M0 mid/low rectal cancer who undergo the treatment modality of 'NCRT with combined chemotherapy (Capox regimen) + radical surgery + ACT' Receives: Drug: capecitabine with oxaliplatin |
| Group B2 | Active comparator | Patients with cT4NanyM0 or cTanyN2M0 mid/low rectal cancer who undergo the treatment modality of 'NCRT with single-agent chemotherapy (Capecitabine) + radical surgery + ACT' Receives: Drug: capecitabine |
| Group C1 | Experimental | Patients with locally advanced rectal cancer, being clinically staged cCR after NCRT, who undergo the transanal endoscopic microsurgery (TEM) excision of the lesion. Receives: Procedure: TEM |
| Group C2 | Active comparator | Patients with locally advanced rectal cancer, being clinically staged cCR after NCRT, who undergo the radical resection of the lesion. Receives: Procedure: radical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3y-DFS
the 3-year disease free survival rate
Measured: 3 years
Secondary outcomes (4)
3y-OS
the 3-year overall survival rate
Measured: 3 years
5y-DFS
the 5-year disease free survival rate
Measured: 5 years
5y-OS
the 5-year overall survival rate
Measured: 5 years
pCR
pathological complete tumor response rate
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startFeb 2017 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer, AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Beijing Chao Yang Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Beijing Friendship Hospital, Geneplus-Beijing Co. Ltd.
- Responsible party
- Principal investigator, Guole Lin, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042000
- Sponsor's protocol ID
- PUMCH-Colorectal Surgery 02
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2017
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou J, Qiu H, Lin G, Xiao Y, Wu B, Wu W, Sun X, Lu J, Zhang G, Xu L, Liu Y. Is adjuvant chemotherapy necessary for patients with pathological complete response after neoadjuvant chemoradiotherapy and radical surgery in locally advanced rectal cancer? Long-term analysis of 40 ypCR patients at a single center. Int J Colorectal Dis. 2016 Jun;31(6):1163-8. doi: 10.1007/s00384-016-2579-5. Epub 2016 Apr 5.
PubMed 27044403Ferrari L, Fichera A. Neoadjuvant chemoradiation therapy and pathological complete response in rectal cancer. Gastroenterol Rep (Oxf). 2015 Nov;3(4):277-88. doi: 10.1093/gastro/gov039. Epub 2015 Aug 19.
PubMed 26290512Breugom AJ, Swets M, Bosset JF, Collette L, Sainato A, Cionini L, Glynne-Jones R, Counsell N, Bastiaannet E, van den Broek CB, Liefers GJ, Putter H, van de Velde CJ. Adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with rectal cancer: a systematic review and meta-analysis of individual patient data. Lancet Oncol. 2015 Feb;16(2):200-7. doi: 10.1016/S1470-2045(14)71199-4. Epub 2015 Jan 12.
PubMed 25589192Bosset JF, Calais G, Mineur L, Maingon P, Stojanovic-Rundic S, Bensadoun RJ, Bardet E, Beny A, Ollier JC, Bolla M, Marchal D, Van Laethem JL, Klein V, Giralt J, Clavere P, Glanzmann C, Cellier P, Collette L; EORTC Radiation Oncology Group. Fluorouracil-based adjuvant chemotherapy after preoperative chemoradiotherapy in rectal cancer: long-term results of the EORTC 22921 randomised study. Lancet Oncol. 2014 Feb;15(2):184-90. doi: 10.1016/S1470-2045(13)70599-0. Epub 2014 Jan 17.
PubMed 24440473Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA Jr, Kinzler KW. Cancer genome landscapes. Science. 2013 Mar 29;339(6127):1546-58. doi: 10.1126/science.1235122.
PubMed 23539594Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.
PubMed 24553385Dawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13.
PubMed 23484797Zhou J, Chang L, Guan Y, Yang L, Xia X, Cui L, Yi X, Lin G. Application of Circulating Tumor DNA as a Non-Invasive Tool for Monitoring the Progression of Colorectal Cancer. PLoS One. 2016 Jul 26;11(7):e0159708. doi: 10.1371/journal.pone.0159708. eCollection 2016.
PubMed 27459628Reinert T, Scholer LV, Thomsen R, Tobiasen H, Vang S, Nordentoft I, Lamy P, Kannerup AS, Mortensen FV, Stribolt K, Hamilton-Dutoit S, Nielsen HJ, Laurberg S, Pallisgaard N, Pedersen JS, Orntoft TF, Andersen CL. Analysis of circulating tumour DNA to monitor disease burden following colorectal cancer surgery. Gut. 2016 Apr;65(4):625-34. doi: 10.1136/gutjnl-2014-308859. Epub 2015 Feb 4.
PubMed 25654990Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.
PubMed 27384348Jung KU, Kim HC, Park JO, Park YS, Park HC, Choi DH, Cho YB, Yun SH, Lee WY, Chun HK. Adjuvant chemotherapy after neoadjuvant chemoradiation and curative resection for rectal cancer: is it necessary for all patients? J Surg Oncol. 2015 Mar 15;111(4):439-44. doi: 10.1002/jso.23835. Epub 2014 Dec 9.
PubMed 25488390
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Clinical Trial to Investigate the Combined Modality Therapy for Locally Advanced Mid/Low Rectal Cancer.
- ClinicalTrials.gov ID
- NCT03042000
- Acronym / sponsor ID
- PUMCH-Colorectal Surgery 02
- Keywords
- rectal cancer, neoadjuvant chemoradiation, circulating tumor DNA, local recurrence, long-term survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, Beijing Chao Yang Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Beijing Friendship Hospital, Geneplus-Beijing Co. Ltd.
- Study start
- Feb 2017 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 3 Feb 2017 (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.
At present, the combined modality treatment of preoperative neoadjuvant chemoradiotherapy (NCRT) followed by radical surgery has become the standard of care for the locally advanced mid/low rectal cancer, having been proved to substantially improve the local control of the disease, whereas not being able to improve the long-term survival. According to present clinical practice guidelines, all patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer are recommended to undergo the preoperative long-term radiotherapy with concurrent 5FU based chemotherapy, followed by the radical resection of the tumor. After surgery, adjuvant chemotherapy (ACT) is recommended for all these patients without considering the postoperative pathological results. Recently, however, some authors proposed that different strategy of combined modality therapy should be applied in different patients according to their risk of relapse, instead of using the uniform NCRT strategy. In this research, on the basis of investigator's previous clinical practice and researches, investigators plan to stratify the patients with cT3-4N0M0 or cTanyN1-2M0 mid/low rectal cancer into several subgroups according to tumor stages and the risk of relapse. Different therapeutic strategy will be applied in different groups, at the aim of improving the overall therapeutic effects, as well as reducing the treatment adverse effects.
This research consists of four trials.
Detailed description
Trial A: A multicenter, prospective, randomized trial to compare neoadjuvant chemoradiotherapy (NCRT) followed by radical surgery with surgery alone for cT3a-bN0-1aM0 mid rectal cancer.
Research objects: Patients with locally advanced rectal cancer, being clinically staged T3a-bN0-1aM0 by rectal MRI and/or endorectal ultrasonography (ERUS), the tumor being located 6-12 cm above the anal verge.
After giving fully informed consent, the prospective participants will be randomly divided into two groups, receiving the following two treatment modalities.
Group A1: radical surgery + adjuvant chemotherapy (ACT) Group A2: NCRT + radical surgery + ACT
Trial B: A multicenter, prospective, randomized trial to compare combined versus single-agent chemotherapy with concurrent radiotherapy for cT4NanyM0 or cTanyN2M0 rectal cancer.
Research objects: Patients with locally advanced rectal cancer, being clinically staged cT4NanyM0 or cTanyN2M0 by rectal MRI and/or ERUS, or patients with any other risk factors for tumor relapse.
After giving fully informed consent, the prospective participants will be randomly divided into two groups, receiving the following two treatment modalities.
Group A1: NCRT with combined chemotherapy (Capox regimen) + radical surgery + ACT Group A2: NCRT with single-agent chemotherapy (Capecitabine) + radical surgery + ACT
Trial C: A multicenter, prospective, randomized trial to compare transanal ndoscopic microsurgery (TEM) excision versus radical resection of rectal cancer being staged clinical complete response (cCR) after NCRT.
Research objects: Patients with locally advanced rectal cancer, being clinically staged cCR after NCRT.
After giving fully informed consent, the prospective participants will be randomly divided into two groups, receiving the following two treatment modalities.
Group A1: TEM excision + ACT Group A2: radical surgery + ACT
Trial D: A prospective, observational study to determine the value of circulating tumor DNA (ctDNA) for predicting the therapeutic effects of NCRT for locally advanced rectal cancer and the patients' long-term prognosis.
Research objects: Patients with locally advanced mid/low rectal cancer (cT3-4N0M0 or cTanyN+M0) who undergo NCRT.
After giving fully informed consent, the prospective participants will undergo the classical 'NCRT + radical surgery + ACT' comprehensive treatment. Serial analysis of ctDNA will be performed at specific time points including pre-NCRT, post-NCRT, postoperative week 1, post-ACT, postoperative year 1, 2, and 3. The next-generation sequencing of surgical specimens will be performed as well. Participants will be observed and examined during the entire course of treatment and the follow-up period. The pathological results of the surgical specimen and the 3 year disease free survival (3y-DFS) will be the main end-points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A1 | Experimental | Other: non-NCRTPatients with cT3a-bN0-1aM0 mid rectal cancer who undergo the treatment modality of 'radical surgery + adjuvant chemotherapy (ACT)' |
| Group A2 | Active comparator | Other: NCRTPatients with cT3a-bN0-1aM0 mid rectal cancer who undergo the treatment modality of 'NCRT + radical surgery + ACT' |
| Group B1 | Experimental | Drug: capecitabine with oxaliplatinPatients with cT4NanyM0 or cTanyN2M0 mid/low rectal cancer who undergo the treatment modality of 'NCRT with combined chemotherapy (Capox regimen) + radical surgery + ACT' |
| Group B2 | Active comparator | Drug: capecitabinePatients with cT4NanyM0 or cTanyN2M0 mid/low rectal cancer who undergo the treatment modality of 'NCRT with single-agent chemotherapy (Capecitabine) + radical surgery + ACT' |
| Group C1 | Experimental | Procedure: TEMPatients with locally advanced rectal cancer, being clinically staged cCR after NCRT, who undergo the transanal endoscopic microsurgery (TEM) excision of the lesion. |
| Group C2 | Active comparator | Procedure: radical resectionPatients with locally advanced rectal cancer, being clinically staged cCR after NCRT, who undergo the radical resection of the lesion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 75 years old. Patients with cT3-4N0M0 or cTanyN+M0 mid/low rectal cancer. Patients with ASA physical status scroe of I to III. Patients who can fully understand the content of the informed consent form and sign it upon their own opinions.
- Patients who can coordinate with the researchers to undergo the long-term post-treatment rechecks and follow-ups.
Key exclusion criteria (4 listed)
- Patient has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the evaluation of the patient (e.g., end-stage liver disease, pulmonary hypertension, systemic lupus erythematosis etc.).
- Patient is pregnant or lactating. Patient has a history of malignancy within 5 years except curatively treated basal cell carcinoma, squamous cell carcinoma in a non-mucosal, ultraviolet exposed area, or cervical carcinoma.
- Patient is participating in any other clinical trials within 30 days prior to screening.
- Patient has severe mental illness. Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject.
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 |
|---|---|---|
| non-NCRTwithout the preoperative concurrent chemoradiothearpy (no neoadjuvant chemoradiation) | Other | Group A1 |
| NCRTthe preoperative concurrent chemoradiothearpy (neoadjuvant chemoradiation) | Other | Group A2 |
| capecitabine with oxaliplatincombined chemotherapy with capecitabine with oxaliplatin | Drug | Group B1 |
| capecitabinesingle-agent chemotherapy with capecitabine | Drug | Group B2 |
| TEMtransanal endoscopic microsurgery (TEM) excision of the lesion | Procedure or surgery | Group C1 |
| radical resectionradical resection of rectal cancer | Procedure or surgery | Group C2 |
Primary outcome
3y-DFS
Time frame: 3 years
the 3-year disease free survival rate
4 secondary outcomes
3y-OS
Time frame: 3 years
5y-DFS
Time frame: 5 years
5y-OS
Time frame: 5 years
pCR
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Background: PubMed 27044403Zhou J, Qiu H, Lin G, Xiao Y, Wu B, Wu W, Sun X, Lu J, Zhang G, Xu L, Liu Y. Is adjuvant chemotherapy necessary for patients with pathological complete response after neoadjuvant chemoradiotherapy and radical surgery in locally advanced rectal cancer? Long-term analysis of 40 ypCR patients at a single center. Int J Colorectal Dis. 2016 Jun;31(6):1163-8. doi: 10.1007/s00384-016-2579-5. Epub 2016 Apr 5.
- Background: PubMed 26290512Ferrari L, Fichera A. Neoadjuvant chemoradiation therapy and pathological complete response in rectal cancer. Gastroenterol Rep (Oxf). 2015 Nov;3(4):277-88. doi: 10.1093/gastro/gov039. Epub 2015 Aug 19.
- Background: PubMed 25589192Breugom AJ, Swets M, Bosset JF, Collette L, Sainato A, Cionini L, Glynne-Jones R, Counsell N, Bastiaannet E, van den Broek CB, Liefers GJ, Putter H, van de Velde CJ. Adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with rectal cancer: a systematic review and meta-analysis of individual patient data. Lancet Oncol. 2015 Feb;16(2):200-7. doi: 10.1016/S1470-2045(14)71199-4. Epub 2015 Jan 12.
- Background: PubMed 24440473Bosset JF, Calais G, Mineur L, Maingon P, Stojanovic-Rundic S, Bensadoun RJ, Bardet E, Beny A, Ollier JC, Bolla M, Marchal D, Van Laethem JL, Klein V, Giralt J, Clavere P, Glanzmann C, Cellier P, Collette L; EORTC Radiation Oncology Group. Fluorouracil-based adjuvant chemotherapy after preoperative chemoradiotherapy in rectal cancer: long-term results of the EORTC 22921 randomised study. Lancet Oncol. 2014 Feb;15(2):184-90. doi: 10.1016/S1470-2045(13)70599-0. Epub 2014 Jan 17.
- Background: PubMed 23539594Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA Jr, Kinzler KW. Cancer genome landscapes. Science. 2013 Mar 29;339(6127):1546-58. doi: 10.1126/science.1235122.
- Background: PubMed 24553385Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.
- Background: PubMed 23484797Dawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13.
- Background: PubMed 27459628Zhou J, Chang L, Guan Y, Yang L, Xia X, Cui L, Yi X, Lin G. Application of Circulating Tumor DNA as a Non-Invasive Tool for Monitoring the Progression of Colorectal Cancer. PLoS One. 2016 Jul 26;11(7):e0159708. doi: 10.1371/journal.pone.0159708. eCollection 2016.
- Background: PubMed 25654990Reinert T, Scholer LV, Thomsen R, Tobiasen H, Vang S, Nordentoft I, Lamy P, Kannerup AS, Mortensen FV, Stribolt K, Hamilton-Dutoit S, Nielsen HJ, Laurberg S, Pallisgaard N, Pedersen JS, Orntoft TF, Andersen CL. Analysis of circulating tumour DNA to monitor disease burden following colorectal cancer surgery. Gut. 2016 Apr;65(4):625-34. doi: 10.1136/gutjnl-2014-308859. Epub 2015 Feb 4.
- Background: PubMed 27384348Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.
- Background: PubMed 25488390Jung KU, Kim HC, Park JO, Park YS, Park HC, Choi DH, Cho YB, Yun SH, Lee WY, Chun HK. Adjuvant chemotherapy after neoadjuvant chemoradiation and curative resection for rectal cancer: is it necessary for all patients? J Surg Oncol. 2015 Mar 15;111(4):439-44. doi: 10.1002/jso.23835. Epub 2014 Dec 9.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing non-NCRT, NCRT and capecitabine with oxaliplatin in people with Rectal Cancer, Adenocarcinoma and Neoadjuvant Chemoradiation, run by Peking Union Medical College Hospital.
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 2 inclusion and 4 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Jiaolin Zhou, MD. (8613910136704, conniezhjl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3y-DFS (time frame: 3 years). 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 NCT03042000, which also lists 11 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 3 Feb 2017.